Trial Outcomes & Findings for Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design (NCT NCT04583891)
NCT ID: NCT04583891
Last Updated: 2025-11-10
Results Overview
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
COMPLETED
NA
313 participants
Baseline
2025-11-10
Participant Flow
3 participants withdrew from the study shortly after being randomized to IntelliCare and never accessed the program. They are therefore not included in any IntelliCare subgroups (i.e., IntelliCare - High Engager, No Coaching; IntelliCare - Low Engager, No Coaching; IntelliCare - Low Engager, Coaching). Subgroup assignment is based on participant engagement with IntelliCare, and because these participants withdrew before engaging with the program, they do not fit into any IntelliCare subgroup.
Participant milestones
| Measure |
IntelliCare - Low Engager, No Coaching
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - High Engager, No Coaching
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
38
|
134
|
34
|
104
|
|
Overall Study
COMPLETED
|
33
|
130
|
32
|
94
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
2
|
10
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Mobile Apps to Reduce Distress in Breast Cancer Survivors Using an Adaptive Design
Baseline characteristics by cohort
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=104 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
Total
n=310 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.4 years
STANDARD_DEVIATION 10.7 • n=5 Participants
|
50.0 years
STANDARD_DEVIATION 10.9 • n=20 Participants
|
50.2 years
STANDARD_DEVIATION 10.9 • n=40 Participants
|
52.2 years
STANDARD_DEVIATION 10.2 • n=28 Participants
|
51.6 years
STANDARD_DEVIATION 10.5 • n=46 Participants
|
|
Sex: Female, Male
Female
|
134 Participants
n=5 Participants
|
38 Participants
n=20 Participants
|
34 Participants
n=40 Participants
|
104 Participants
n=28 Participants
|
310 Participants
n=46 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
2 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
5 Participants
n=28 Participants
|
19 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
124 Participants
n=5 Participants
|
36 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
96 Participants
n=28 Participants
|
288 Participants
n=46 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
3 Participants
n=28 Participants
|
3 Participants
n=46 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
0 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
4 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
0 Participants
n=28 Participants
|
1 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=5 Participants
|
5 Participants
n=20 Participants
|
4 Participants
n=40 Participants
|
7 Participants
n=28 Participants
|
25 Participants
n=46 Participants
|
|
Race (NIH/OMB)
White
|
120 Participants
n=5 Participants
|
32 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
91 Participants
n=28 Participants
|
271 Participants
n=46 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
5 Participants
n=28 Participants
|
8 Participants
n=46 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
1 Participants
n=28 Participants
|
1 Participants
n=46 Participants
|
PRIMARY outcome
Timeframe: BaselinePopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=104 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Patient Health Questionnaire-8
|
12.1 score on a scale
Standard Deviation 4.6
|
11.8 score on a scale
Standard Deviation 4.1
|
12.5 score on a scale
Standard Deviation 4.5
|
12.7 score on a scale
Standard Deviation 4.4
|
PRIMARY outcome
Timeframe: Post 8 weeksPopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=122 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Patient Health Questionnaire-8
|
8.1 score on a scale
Standard Deviation 5.1
|
10.5 score on a scale
Standard Deviation 5.8
|
7.2 score on a scale
Standard Deviation 4.4
|
9.4 score on a scale
Standard Deviation 4.9
|
PRIMARY outcome
Timeframe: 6 month follow upPopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=121 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=93 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Patient Health Questionnaire-8
|
7.2 score on a scale
Standard Deviation 4.9
|
7.4 score on a scale
Standard Deviation 4.3
|
7.2 score on a scale
Standard Deviation 5.1
|
8.8 score on a scale
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: 12 month follow upPopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
8 item scale that measures depression symptoms on a continuous scale. Scores range from 0-24, with a higher score indicating greater severity of symptoms of depression.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=120 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=90 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Patient Health Questionnaire-8
|
6.7 score on a scale
Standard Deviation 4.9
|
7.4 score on a scale
Standard Deviation 3.9
|
6.6 score on a scale
Standard Deviation 5.6
|
8.3 score on a scale
Standard Deviation 5.9
|
PRIMARY outcome
Timeframe: BaselinePopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=104 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7
|
11.4 score on a scale
Standard Deviation 4.0
|
12.2 score on a scale
Standard Deviation 5.0
|
12.4 score on a scale
Standard Deviation 5.2
|
12.6 score on a scale
Standard Deviation 4.7
|
PRIMARY outcome
Timeframe: Post 8 weeksPopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=94 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7
|
6.9 score on a scale
Standard Deviation 4.6
|
7.6 score on a scale
Standard Deviation 4.5
|
7.7 score on a scale
Standard Deviation 5.1
|
8.9 score on a scale
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: 6 month follow upPopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=127 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=94 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7
|
6.3 score on a scale
Standard Deviation 5.0
|
7.0 score on a scale
Standard Deviation 4.6
|
7.3 score on a scale
Standard Deviation 5.7
|
8.0 score on a scale
Standard Deviation 5.5
|
PRIMARY outcome
Timeframe: 12 month follow upPopulation: Breast Cancer Survivors who were classified as high or low engagers and who completed every item of this measure
7 item scale that measures anxiety symptoms on a continuous scale. Scores range from 0-21, with a higher score indicating greater severity of symptoms of anxiety.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=123 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=89 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Generalized Anxiety Disorder-7
|
5.7 score on a scale
Standard Deviation 5.1
|
6.0 score on a scale
Standard Deviation 4.2
|
7.2 score on a scale
Standard Deviation 5.6
|
7.5 score on a scale
Standard Deviation 5.8
|
SECONDARY outcome
Timeframe: Frequency of unique app sessions from Baseline through 8 weeksPopulation: Includes only participants who downloaded their assigned app or intervention.
Frequency of unique app sessions from Baseline through 8 weeks based on median number of app sessions
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=102 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
App Engagement From App Sessions
Week 1
|
12 app sessions
Interval 8.5 to 15.5
|
6 app sessions
Interval 3.5 to 8.5
|
7 app sessions
Interval 5.0 to 9.0
|
2 app sessions
Interval 1.0 to 3.0
|
|
App Engagement From App Sessions
Week 2
|
9 app sessions
Interval 5.0 to 13.0
|
4 app sessions
Interval 2.0 to 6.0
|
4.5 app sessions
Interval 2.0 to 7.0
|
0 app sessions
Interval 0.0 to 1.0
|
|
App Engagement From App Sessions
Week 3
|
8 app sessions
Interval 4.5 to 11.5
|
2.5 app sessions
Interval 1.0 to 4.0
|
5 app sessions
Interval 2.5 to 7.5
|
0 app sessions
Interval 0.0 to 0.0
|
|
App Engagement From App Sessions
Week 4
|
7 app sessions
Interval 3.5 to 10.5
|
1 app sessions
Interval 0.0 to 4.0
|
5 app sessions
Interval 2.0 to 8.0
|
0 app sessions
Interval 0.0 to 0.0
|
|
App Engagement From App Sessions
Week 5
|
6 app sessions
Interval 3.0 to 9.0
|
2 app sessions
Interval 0.5 to 3.5
|
3.5 app sessions
Interval 1.5 to 5.5
|
0 app sessions
Interval 0.0 to 0.0
|
|
App Engagement From App Sessions
Week 6
|
5 app sessions
Interval 2.5 to 7.5
|
1 app sessions
Interval 0.0 to 3.0
|
4 app sessions
Interval 2.0 to 6.0
|
0 app sessions
Interval 0.0 to 0.0
|
|
App Engagement From App Sessions
Week 7
|
5 app sessions
Interval 2.0 to 8.0
|
0.5 app sessions
Interval 0.0 to 4.0
|
4.5 app sessions
Interval 2.5 to 6.5
|
0 app sessions
Interval 0.0 to 0.0
|
|
App Engagement From App Sessions
Week 8
|
4 app sessions
Interval 0.5 to 7.5
|
0.5 app sessions
Interval 0.0 to 3.0
|
3.5 app sessions
Interval 1.5 to 5.5
|
0 app sessions
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: Duration in seconds of app sessions from Baseline through 8 weeksPopulation: Technical problems led to not being able to extract app engagement based on app session duration from any participants. Data related to the gold standard metric of number of app sessions was captured and reported.
Duration in seconds of app sessions from Baseline through 8 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Number of apps downloaded from Baseline through 8 weeksPopulation: Technical problems led to not being able to extract app engagement based on number of app downloads from any participants. Data related to the gold standard metric of number of app sessions was captured and reported.
Number of apps downloaded from Baseline through 8 weeks
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: BaselineThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=104 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Physical Health
|
35.5 score on a scale
Standard Deviation 40.9
|
41.4 score on a scale
Standard Deviation 36.9
|
39.7 score on a scale
Standard Deviation 42.2
|
35.7 score on a scale
Standard Deviation 39.4
|
SECONDARY outcome
Timeframe: 8 weekThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=129 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Physical Health
|
44.7 score on a scale
Standard Deviation 41.9
|
45.8 score on a scale
Standard Deviation 36.6
|
53.8 score on a scale
Standard Deviation 41.5
|
44.5 score on a scale
Standard Deviation 40.2
|
SECONDARY outcome
Timeframe: 6 monthsThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=127 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Physical Health
|
60.3 score on a scale
Standard Deviation 42.1
|
51.5 score on a scale
Standard Deviation 41.0
|
56.5 score on a scale
Standard Deviation 45.2
|
49.0 score on a scale
Standard Deviation 40.1
|
SECONDARY outcome
Timeframe: 12 monthsThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=92 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Physical Health
|
65.9 score on a scale
Standard Deviation 41.3
|
52.3 score on a scale
Standard Deviation 41.6
|
56.0 score on a scale
Standard Deviation 42.5
|
56.8 score on a scale
Standard Deviation 41.8
|
SECONDARY outcome
Timeframe: BaselineThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=104 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Mental Health
|
54.2 score on a scale
Standard Deviation 16.3
|
47.9 score on a scale
Standard Deviation 16.8
|
48.2 score on a scale
Standard Deviation 14.6
|
48.6 score on a scale
Standard Deviation 16.9
|
SECONDARY outcome
Timeframe: 8 weeksThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=129 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Mental Health
|
62.7 score on a scale
Standard Deviation 17.5
|
59.3 score on a scale
Standard Deviation 18.2
|
57.8 score on a scale
Standard Deviation 19.5
|
55.3 score on a scale
Standard Deviation 18.3
|
SECONDARY outcome
Timeframe: 6 monthsThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Mental Health
|
69.6 score on a scale
Standard Deviation 16.4
|
60.7 score on a scale
Standard Deviation 19.0
|
60.3 score on a scale
Standard Deviation 20.9
|
61.3 score on a scale
Standard Deviation 17.4
|
SECONDARY outcome
Timeframe: 12 monthsThe SF-36 is a 36 item scale that is composed of 2 summary scores that measure health status related to both physical and mental health. Scores for each domain range from 0-100, with higher scores indicating better health status.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=92 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
36-Item Short Form Survey - Mental Health
|
68.7 score on a scale
Standard Deviation 16.9
|
66.2 score on a scale
Standard Deviation 14.6
|
64.5 score on a scale
Standard Deviation 18.7
|
63.1 score on a scale
Standard Deviation 19.6
|
SECONDARY outcome
Timeframe: BaselineFatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=35 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=95 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Multidimensional Fatigue Symptom Inventory-Short Form
|
35.4 score on a scale
Standard Deviation 19.5
|
38.8 score on a scale
Standard Deviation 16.4
|
42.9 score on a scale
Standard Deviation 17.4
|
42.0 score on a scale
Standard Deviation 19.8
|
SECONDARY outcome
Timeframe: 8 weeksFatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=120 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=35 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=88 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Multidimensional Fatigue Symptom Inventory-Short Form
|
25.3 score on a scale
Standard Deviation 20.1
|
29.5 score on a scale
Standard Deviation 19.3
|
27.2 score on a scale
Standard Deviation 20.1
|
31.3 score on a scale
Standard Deviation 22.5
|
SECONDARY outcome
Timeframe: 6 monthsFatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=118 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=25 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=87 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Multidimensional Fatigue Symptom Inventory-Short Form
|
21.1 score on a scale
Standard Deviation 21.1
|
26.8 score on a scale
Standard Deviation 19.2
|
24.6 score on a scale
Standard Deviation 19.4
|
29.5 score on a scale
Standard Deviation 24.3
|
SECONDARY outcome
Timeframe: 12 monthsFatigue will be measured using the MFSI-SF, which is a 30 item self-report measure comprised of five subscales (general, emotional, physical, mental, vigor) and a total fatigue score. Each subscale score ranges from 0 to 24. The Total MSFI-SF score is calculated by adding the general, physical, emotional and mental subscale scores and subtracting vigor subscale score. Total MFSI-SF score ranges from 0 to 96 with a higher score indicating higher levels of cancer-related fatigue experienced by the patient.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=117 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=85 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Multidimensional Fatigue Symptom Inventory-Short Form
|
19.7 score on a scale
Standard Deviation 22.7
|
24.0 score on a scale
Standard Deviation 18.1
|
20.5 score on a scale
Standard Deviation 22.2
|
25.8 score on a scale
Standard Deviation 23.2
|
SECONDARY outcome
Timeframe: BaselineThe Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=123 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=100 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index
|
10.7 score on a scale
Standard Deviation 4.1
|
10.8 score on a scale
Standard Deviation 3.5
|
10.2 score on a scale
Standard Deviation 4.0
|
11.1 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 8 weeksThe Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=118 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=85 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index
|
9.8 score on a scale
Standard Deviation 4.0
|
9.3 score on a scale
Standard Deviation 3.4
|
8.5 score on a scale
Standard Deviation 4.2
|
9.9 score on a scale
Standard Deviation 4.3
|
SECONDARY outcome
Timeframe: 6 monthsThe Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=112 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=28 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=84 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index
|
8.9 score on a scale
Standard Deviation 3.8
|
10.1 score on a scale
Standard Deviation 3.5
|
8.5 score on a scale
Standard Deviation 4.0
|
9.8 score on a scale
Standard Deviation 4.6
|
SECONDARY outcome
Timeframe: 12 monthsThe Pittsburgh Sleep Quality Index contains 19 self-rated questions that assesses sleep quality and disturbances. Global scores range from 0-21, with a score of 5 or more indicating poor sleep quality. The higher the score, the worse the sleep quality.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=110 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=80 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Pittsburgh Sleep Quality Index
|
8.7 score on a scale
Standard Deviation 4.0
|
9.6 score on a scale
Standard Deviation 3.6
|
8.0 score on a scale
Standard Deviation 3.5
|
9.5 score on a scale
Standard Deviation 4.2
|
SECONDARY outcome
Timeframe: BaselineThe Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=132 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=101 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Alcohol Use Disorders Identification Test
|
2.3 score on a scale
Standard Deviation 3.4
|
4.0 score on a scale
Standard Deviation 5.4
|
2.2 score on a scale
Standard Deviation 2.9
|
1.7 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 8 weeksThe Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Alcohol Use Disorders Identification Test
|
2.0 score on a scale
Standard Deviation 3.4
|
3.5 score on a scale
Standard Deviation 5.1
|
1.9 score on a scale
Standard Deviation 2.6
|
1.5 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 6 monthsThe Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=29 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=95 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Alcohol Use Disorders Identification Test
|
1.7 score on a scale
Standard Deviation 2.9
|
3.3 score on a scale
Standard Deviation 5.3
|
1.6 score on a scale
Standard Deviation 2.6
|
1.5 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 12 monthsThe Alcohol Use Disorders Identification Test contains 10 questions (each question is scored 0-4). The range of possible scores is from 0 to 40 where 0 indicates an abstainer who has never had any problems from alcohol. A score of 1 to 7 suggests low-risk consumption according to World Health Organization (WHO) guidelines. Scores from 8 to 14 suggest hazardous or harmful alcohol consumption and a score of 15 or more indicates the likelihood of alcohol dependence (moderate-severe alcohol use disorder).
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Alcohol Use Disorders Identification Test
|
2.0 score on a scale
Standard Deviation 3.2
|
3.7 score on a scale
Standard Deviation 5.9
|
1.7 score on a scale
Standard Deviation 3.0
|
1.7 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: BaselineThe PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=131 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=37 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=101 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Global Mental Health v1.2
|
39.5 T-score
Standard Deviation 6.3
|
38.8 T-score
Standard Deviation 6.1
|
37.6 T-score
Standard Deviation 5.6
|
38.4 T-score
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 8 weeksThe PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=95 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Global Mental Health v1.2
|
42.6 T-score
Standard Deviation 7.1
|
41.5 T-score
Standard Deviation 6.0
|
42.4 T-score
Standard Deviation 5.6
|
40.3 T-score
Standard Deviation 7.0
|
SECONDARY outcome
Timeframe: 6 monthsThe PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Global Mental Health v1.2
|
45.2 T-score
Standard Deviation 8.6
|
43.7 T-score
Standard Deviation 6.6
|
43.0 T-score
Standard Deviation 6.6
|
41.4 T-score
Standard Deviation 7.9
|
SECONDARY outcome
Timeframe: 12 monthsThe PROMIS Global Mental Health scale v1.2 contains 4 items that measure mental health. Each question is scored on a 1-5 scale with a raw score total range of 4-20. The raw scores are then transformed into a T-score where higher scores indicate better overall health. PROMIS uses T-scores to standardize results, with a mean of 50 and a standard deviation (SD) of 10 for the general U.S. population. A higher T-score for mental health indicates a better outcome.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Global Mental Health v1.2
|
45.5 T-score
Standard Deviation 8.5
|
45.2 T-score
Standard Deviation 6.0
|
44.8 T-score
Standard Deviation 6.6
|
42.6 T-score
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: BaselineThe PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=127 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=35 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=101 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Satisfaction With Sex Life
|
9.4 score on a scale
Standard Deviation 5.0
|
8.9 score on a scale
Standard Deviation 4.6
|
10.6 score on a scale
Standard Deviation 6.5
|
9.2 score on a scale
Standard Deviation 5.0
|
SECONDARY outcome
Timeframe: 8 weeksThe PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=119 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=35 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=95 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Satisfaction With Sex Life
|
9.3 score on a scale
Standard Deviation 5.1
|
9.1 score on a scale
Standard Deviation 5.1
|
11.7 score on a scale
Standard Deviation 6.3
|
9.9 score on a scale
Standard Deviation 5.1
|
SECONDARY outcome
Timeframe: 6 monthsThe PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=123 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=95 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Satisfaction With Sex Life
|
10.5 score on a scale
Standard Deviation 5.9
|
9.7 score on a scale
Standard Deviation 5.6
|
11.6 score on a scale
Standard Deviation 5.9
|
10.2 score on a scale
Standard Deviation 5.7
|
SECONDARY outcome
Timeframe: 12 monthsThe PROMIS Satisfaction with Sex Life scale v.20 contains 5 items that measure satisfaction with one's sex life. Each question is scored on a 1-5 scale with a total score range of 5-25. Higher scores indicate higher satisfaction with one's sex life.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=121 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=90 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
PROMIS Satisfaction With Sex Life
|
10.6 score on a scale
Standard Deviation 6.1
|
10.4 score on a scale
Standard Deviation 6.0
|
12.0 score on a scale
Standard Deviation 6.5
|
10.5 score on a scale
Standard Deviation 5.9
|
SECONDARY outcome
Timeframe: BaselineThe UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=133 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=104 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
UAMS Health Literacy Measure
|
10.3 score on a scale
Standard Deviation 1.2
|
10.7 score on a scale
Standard Deviation 1.0
|
10.3 score on a scale
Standard Deviation 1.3
|
10.4 score on a scale
Standard Deviation 1.1
|
SECONDARY outcome
Timeframe: 8 weeksThe UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
UAMS Health Literacy Measure
|
10.5 score on a scale
Standard Deviation 1.1
|
10.4 score on a scale
Standard Deviation 1.3
|
10.0 score on a scale
Standard Deviation 1.7
|
10.5 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 6 monthsThe UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=127 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
UAMS Health Literacy Measure
|
10.5 score on a scale
Standard Deviation 1.1
|
10.7 score on a scale
Standard Deviation 1.0
|
10.7 score on a scale
Standard Deviation 0.8
|
10.7 score on a scale
Standard Deviation 1.2
|
SECONDARY outcome
Timeframe: 12 monthsThe UAMS Health Literacy measure consists of 3 items that assess health literacy. Each question is scored on a 1-5 scale, with a possible total score range of 3-15. Higher scores indicate worse health literacy.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=92 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
UAMS Health Literacy Measure
|
10.6 score on a scale
Standard Deviation 1.1
|
10.6 score on a scale
Standard Deviation 0.8
|
10.4 score on a scale
Standard Deviation 1.2
|
10.7 score on a scale
Standard Deviation 0.9
|
SECONDARY outcome
Timeframe: BaselineThe Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=124 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=97 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Penn State Worry Questionnaire
|
56.8 score on a scale
Standard Deviation 12.7
|
57.8 score on a scale
Standard Deviation 13.7
|
61.3 score on a scale
Standard Deviation 14.1
|
59.5 score on a scale
Standard Deviation 12.7
|
SECONDARY outcome
Timeframe: 8 weeksThe Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=120 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Penn State Worry Questionnaire
|
53.1 score on a scale
Standard Deviation 12.9
|
54.0 score on a scale
Standard Deviation 12.8
|
54.2 score on a scale
Standard Deviation 14.3
|
55.0 score on a scale
Standard Deviation 12.4
|
SECONDARY outcome
Timeframe: 6 monthsThe Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=122 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=27 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Penn State Worry Questionnaire
|
50.1 score on a scale
Standard Deviation 13.9
|
50.8 score on a scale
Standard Deviation 10.2
|
55.9 score on a scale
Standard Deviation 15.5
|
55.0 score on a scale
Standard Deviation 13.5
|
SECONDARY outcome
Timeframe: 12 monthsThe Penn State Worry Questionnaire consists of 16 items that assess the trait of worry. Each question is scored on a 1-5 scale with a possible total score range of 16-80. Higher scores indicate higher levels of trait worry.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=118 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Penn State Worry Questionnaire
|
48.8 score on a scale
Standard Deviation 13.0
|
49.4 score on a scale
Standard Deviation 12.3
|
51.9 score on a scale
Standard Deviation 14.6
|
54.4 score on a scale
Standard Deviation 14.4
|
SECONDARY outcome
Timeframe: BaselineThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=134 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=100 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory- Extraversion
|
8.0 score on a scale
Standard Deviation 3.5
|
8.1 score on a scale
Standard Deviation 3.5
|
8.8 score on a scale
Standard Deviation 3.7
|
7.4 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 8 weeksThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Extraversion
|
8.1 score on a scale
Standard Deviation 3.2
|
8.2 score on a scale
Standard Deviation 3.4
|
8.7 score on a scale
Standard Deviation 3.9
|
7.3 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: 6 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=95 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Extraversion
|
8.2 score on a scale
Standard Deviation 3.3
|
8.1 score on a scale
Standard Deviation 3.3
|
8.4 score on a scale
Standard Deviation 3.2
|
7.8 score on a scale
Standard Deviation 3.1
|
SECONDARY outcome
Timeframe: 12 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Extraversion is assessed by 2 items, each of which is scored on a 1-7 scale and the responses are summed for a total Extraversion score. Therefore, scores for Extraversion range from 2-14. Higher scores indicates higher levels of Extraversion.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Extraversion
|
8.3 score on a scale
Standard Deviation 3.1
|
7.9 score on a scale
Standard Deviation 3.2
|
8.8 score on a scale
Standard Deviation 3.5
|
8.0 score on a scale
Standard Deviation 3.3
|
SECONDARY outcome
Timeframe: BaselineThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=133 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=101 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Agreeableness
|
10.9 score on a scale
Standard Deviation 2.2
|
10.2 score on a scale
Standard Deviation 2.3
|
10.3 score on a scale
Standard Deviation 2.0
|
10.2 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 8 weeksThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=129 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Agreeableness
|
11.1 score on a scale
Standard Deviation 2.3
|
10.9 score on a scale
Standard Deviation 2.3
|
11.0 score on a scale
Standard Deviation 2.4
|
10.7 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 6 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=127 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=29 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Agreeableness
|
11.2 score on a scale
Standard Deviation 2.3
|
10.8 score on a scale
Standard Deviation 2.2
|
11.1 score on a scale
Standard Deviation 2.1
|
10.7 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 12 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Agreeableness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Agreeableness score. Therefore, scores for Agreeableness range from 2-14. Higher scores indicates higher levels of Agreeableness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Agreeableness
|
11.2 score on a scale
Standard Deviation 2.5
|
10.7 score on a scale
Standard Deviation 2.2
|
10.6 score on a scale
Standard Deviation 2.3
|
11.0 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: BaselineThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=132 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=102 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Conscientiousness
|
11.0 score on a scale
Standard Deviation 2.6
|
10.8 score on a scale
Standard Deviation 2.6
|
10.5 score on a scale
Standard Deviation 2.6
|
10.9 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: 8 weeksThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=31 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Conscientiousness
|
11.2 score on a scale
Standard Deviation 2.2
|
10.4 score on a scale
Standard Deviation 3.0
|
11.0 score on a scale
Standard Deviation 2.8
|
10.7 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 6 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Conscientiousness
|
11.3 score on a scale
Standard Deviation 2.5
|
10.8 score on a scale
Standard Deviation 2.7
|
10.9 score on a scale
Standard Deviation 2.7
|
10.7 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 12 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Conscientiousness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Conscientiousness score. Therefore, scores for Conscientiousness range from 2-14. Higher scores indicates higher levels of Conscientiousness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=88 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Conscientiousness
|
11.2 score on a scale
Standard Deviation 2.4
|
11.0 score on a scale
Standard Deviation 2.7
|
10.0 score on a scale
Standard Deviation 2.8
|
11.1 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: BaselineThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=132 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=103 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Neuroticism
|
7.6 score on a scale
Standard Deviation 2.7
|
7.7 score on a scale
Standard Deviation 2.6
|
6.6 score on a scale
Standard Deviation 2.7
|
7.3 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 8 weeksThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=35 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=97 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Neuroticism
|
8.5 score on a scale
Standard Deviation 2.7
|
8.5 score on a scale
Standard Deviation 2.5
|
8.3 score on a scale
Standard Deviation 2.8
|
7.9 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 6 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Neuroticism
|
8.9 score on a scale
Standard Deviation 3.0
|
8.5 score on a scale
Standard Deviation 2.5
|
8.4 score on a scale
Standard Deviation 2.5
|
8.2 score on a scale
Standard Deviation 2.8
|
SECONDARY outcome
Timeframe: 12 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Neuroticism is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Neuroticism score. Therefore, scores for Neuroticism range from 2-14. Higher scores indicates higher levels of Neuroticism.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=125 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=91 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Neuroticism
|
9.5 score on a scale
Standard Deviation 2.7
|
8.9 score on a scale
Standard Deviation 2.6
|
8.3 score on a scale
Standard Deviation 2.8
|
8.4 score on a scale
Standard Deviation 2.9
|
SECONDARY outcome
Timeframe: BaselineThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=133 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=38 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=34 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=102 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Openness
|
10.1 score on a scale
Standard Deviation 2.5
|
9.7 score on a scale
Standard Deviation 2.3
|
10.8 score on a scale
Standard Deviation 2.0
|
9.6 score on a scale
Standard Deviation 2.5
|
SECONDARY outcome
Timeframe: 8 weeksThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=128 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=98 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Openness
|
10.2 score on a scale
Standard Deviation 2.3
|
10.2 score on a scale
Standard Deviation 2.5
|
10.5 score on a scale
Standard Deviation 2.0
|
9.6 score on a scale
Standard Deviation 2.7
|
SECONDARY outcome
Timeframe: 6 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=30 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=96 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Ten Item Personality Inventory - Openness
|
10.2 score on a scale
Standard Deviation 2.5
|
10.6 score on a scale
Standard Deviation 2.7
|
10.5 score on a scale
Standard Deviation 2.1
|
10.2 score on a scale
Standard Deviation 2.3
|
SECONDARY outcome
Timeframe: 12 monthsThe Ten Item Personality Inventory consists of 10 items that assess the Big 5 personality domains (i.e., conscientiousness, openness, agreeableness, extraversion, neuroticism). Openness is assessed by 2 of the items, each of which is scored on a 1-7 scale and the responses are summed for a total Openness score. Therefore, scores for Openness range from 2-14. Higher scores indicates higher levels of Openness.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=126 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=32 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=90 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
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|---|---|---|---|---|
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Ten Item Personality Inventory - Openness
|
10.4 score on a scale
Standard Deviation 2.4
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10.0 score on a scale
Standard Deviation 2.6
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10.2 score on a scale
Standard Deviation 2.5
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10.2 score on a scale
Standard Deviation 2.7
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SECONDARY outcome
Timeframe: BaselinePopulation: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 8 weeksPopulation: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 6 monthsPopulation: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 12 monthsPopulation: This measure was not administered because it was deemed to be redundant with the other intervention engagement and adherence measures. It was omitted to reduce participant burden.
The TWEETS scale consists of 9 items on a 5-point Likert scale (0-4). Of the 9 items, 3 are aimed at assessing behavioral engagement, 3 on cognitive engagement, and 3 of affective engagement. Higher scores indicate higher levels on each of the engagement domains.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksA 12-item questionnaire with subscales of perceived utility and perceived impact of digital interventions. Each item is rated on a 0 (not at all) to 5 (very) scale and the items are summed to compute a total score ranging from 0-60. Higher scores indicate higher perceived utility and impact of a digital intervention.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=132 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=100 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Digital Intervention Evaluation Questionnaire
|
27.8 score on a scale
Standard Deviation 10.5
|
25.7 score on a scale
Standard Deviation 10.4
|
30.4 score on a scale
Standard Deviation 9.7
|
23.5 score on a scale
Standard Deviation 10.7
|
OTHER_PRE_SPECIFIED outcome
Timeframe: 8 weeksA 26 item questionnaire that assesses perceived adherence to a digital intervention due to barriers to use. Each item is scored on a 0 (not at all) to 2 (very) scale and the items are summed to compute a total score ranging from 0-52. Higher scores indicate lower perceived adherence to a digital intervention due to barriers to use.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=132 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=36 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=33 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
n=100 Participants
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Digital Intervention Adherence Questionnaire
|
7.6 score on a scale
Standard Deviation 7.1
|
10.6 score on a scale
Standard Deviation 9.3
|
7.3 score on a scale
Standard Deviation 6.0
|
5.1 score on a scale
Standard Deviation 5.9
|
POST_HOC outcome
Timeframe: 8 weeksPopulation: The data collected were qualitative based on interviews with participants who received IntelliCare. The "Patient Education" participants did not receive the Intellicare App. The count of participants that endorsed each theme is provided, however, it is important to stress that the goal was to identify meaningful patterns and concepts within the data, not just count how many people mention a theme.
The purpose of collecting this data was to explore how the intervention could be improved upon in future trials. Only those that receive the IntelliCare apps will be administered a qualitative interview that contains items assessing how the app intervention met their needs as a breast cancer survivor and possible changes to improve fit. Study staff will administer this interview on the phone and manually type in the participant responses during the interview. 10 questions will assess overall impressions of the IntelliCare app program to inform how it could be improved upon for future trials. When new data no longer adds new information or a new theme to the analysis, the theme is considered sufficiently explored and important. A numerical threshold for theme importance in qualitative analysis is not important, as this can lead to losing valuable, nuanced insights.
Outcome measures
| Measure |
IntelliCare - High Engager, No Coaching
n=44 Participants
This arm included participants who received IntelliCare and displayed optimal levels of engagement to the intervention in the first week. These participants were not eligible to receive added coaching after week two. They continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, No Coaching
n=23 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive no added coaching and continued to use IntelliCare as usual.
|
IntelliCare - Low Engager, Coaching
n=19 Participants
This arm included participants who received IntelliCare and displayed suboptimal levels of engagement to the intervention in the first week. These participants were eligible to receive added coaching after week two. They were randomized to receive added coaching which consisted of an initial phone call with a human coach, a midpoint check-in, and regular messaging with their coach.
|
Patient Education
The patient education app will contain psychoeducational information about distress prevalence and distress management. It will serve as an active control condition to compare with the IntelliCare apps.
Psychoeducation: The Patient Education app will contain content relevant for general distress management. This includes information about thoughts/worries, prevalence of mood symptoms, CBT strategies for coping with negative affect, and other information typical of education-based mental health apps. The structure of this app will closely mirror patient education websites and apps which mimic the form and structure of apps that target cancer survivors and that primarily provide educational information about cancer and related symptoms.
|
|---|---|---|---|---|
|
Limited List of Questions for Exit Interview
More variety of activities in the behavioral activation portion of the intervention
|
3 Participants
|
4 Participants
|
4 Participants
|
0 Participants
|
|
Limited List of Questions for Exit Interview
Create a progress report for users as they use the app over time
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Limited List of Questions for Exit Interview
Include cancer related examples in the activities in the app to make them more relatable
|
17 Participants
|
8 Participants
|
9 Participants
|
0 Participants
|
|
Limited List of Questions for Exit Interview
Make loading pictures easier
|
2 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Limited List of Questions for Exit Interview
Have a way for users to connect with one another directly to provide emotional support
|
8 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Limited List of Questions for Exit Interview
Want more variety of activities and exercises to choose from to learn additional skills
|
10 Participants
|
6 Participants
|
3 Participants
|
0 Participants
|
Adverse Events
IntelliCare - High Engager, No Coaching
IntelliCare - Low Engager, No Coaching
IntelliCare - Low Engager, Coaching
Patient Education
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place