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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

313 participants

Primary outcome timeframe

Baseline

Results posted on

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

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

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: Baseline

Population: 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

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 weeks

Population: 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

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 up

Population: 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

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 up

Population: 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

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: Baseline

Population: 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

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 weeks

Population: 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

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 up

Population: 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

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 up

Population: 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

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 weeks

Population: 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

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 weeks

Population: 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 weeks

Population: 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: Baseline

The 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

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 week

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

Fatigue 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

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 weeks

Fatigue 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

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 months

Fatigue 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

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 months

Fatigue 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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: Baseline

The 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

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 weeks

The 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

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 months

The 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

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 months

The 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

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.
Ten Item Personality Inventory - Openness
10.4 score on a scale
Standard Deviation 2.4
10.0 score on a scale
Standard Deviation 2.6
10.2 score on a scale
Standard Deviation 2.5
10.2 score on a scale
Standard Deviation 2.7

SECONDARY outcome

Timeframe: Baseline

Population: 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 weeks

Population: 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 months

Population: 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 months

Population: 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 weeks

A 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

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 weeks

A 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

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 weeks

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 1 deaths

IntelliCare - Low Engager, No Coaching

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

IntelliCare - Low Engager, Coaching

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Patient Education

Serious events: 0 serious events
Other events: 0 other events
Deaths: 2 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Philip Chow

University of Virginia

Phone: 9146453458

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place