Trial Outcomes & Findings for Efficacy of a Couple-Focused mHealth Symptom Self-management Program (NCT NCT03489057)
NCT ID: NCT03489057
Last Updated: 2024-10-03
Results Overview
The Functional Assessment of Cancer Therapy - General (FACT-G) is used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General is a 27-item survey which assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time.
COMPLETED
NA
560 participants
Baseline, month 4, 8 and 12
2024-10-03
Participant Flow
We recruited 280 patients with newly treated localized prostate cancer and their partner caregivers, with a total of 560 individuals into the study
All participants completed informed consent and the baseline assessment of quality of life, symptoms, and their stress-coping processes.
Participant milestones
| Measure |
Participants Receive PERC
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to the experimental condition will receive access to the PERC website.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Caregivers of Participants Receive PERC
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to the experimental condition will receive access to the PERC website. Caregivers of participants receive PERC.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Participants Receive Usual Care
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
Caregivers of Participants Receive Usual Care
Caregivers of participants receive usual care. Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
141
|
141
|
139
|
139
|
|
Overall Study
COMPLETED
|
106
|
106
|
115
|
115
|
|
Overall Study
NOT COMPLETED
|
35
|
35
|
24
|
24
|
Reasons for withdrawal
| Measure |
Participants Receive PERC
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to the experimental condition will receive access to the PERC website.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Caregivers of Participants Receive PERC
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to the experimental condition will receive access to the PERC website. Caregivers of participants receive PERC.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Participants Receive Usual Care
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
Caregivers of Participants Receive Usual Care
Caregivers of participants receive usual care. Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
16
|
16
|
14
|
14
|
|
Overall Study
Withdrawal by Subject
|
12
|
12
|
8
|
8
|
|
Overall Study
Protocol Violation
|
7
|
7
|
2
|
2
|
Baseline Characteristics
Efficacy of a Couple-Focused mHealth Symptom Self-management Program
Baseline characteristics by cohort
| Measure |
PERC Program
n=141 Participants
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Caregivers of Participants Receive PERC
n=141 Participants
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to the experimental condition will receive access to the PERC website. Caregivers of participants receive PERC.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Participants Receive Usual Care
n=139 Participants
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
Caregivers of Participants Receive Usual Care
n=139 Participants
Caregivers of participants receive usual care. Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual Care Plus NCI website: The usual Care Plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
Total
n=560 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
64.33 years
STANDARD_DEVIATION 6.87 • n=5 Participants
|
61.38 years
STANDARD_DEVIATION 7.23 • n=7 Participants
|
63.10 years
STANDARD_DEVIATION 6.55 • n=5 Participants
|
60.83 years
STANDARD_DEVIATION 7.50 • n=4 Participants
|
62.41 years
STANDARD_DEVIATION 7.17 • n=21 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
141 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
138 Participants
n=4 Participants
|
279 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
141 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
139 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
281 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
135 Participants
n=5 Participants
|
135 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
134 Participants
n=4 Participants
|
539 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
28 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
28 Participants
n=4 Participants
|
111 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
107 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
108 Participants
n=5 Participants
|
104 Participants
n=4 Participants
|
427 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
141 participants
n=5 Participants
|
141 participants
n=7 Participants
|
139 participants
n=5 Participants
|
139 participants
n=4 Participants
|
560 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline, month 4, 8 and 12Population: The number reported in the results is based on participants.
The Functional Assessment of Cancer Therapy - General (FACT-G) is used to measure change in quality of life of patient and partner from baseline (T1) to T2 (4 months post-T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Functional assessment of Cancer Therapy-General is a 27-item survey which assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=135 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Quality of Life Over Time as Assessed by Functional Assessment of Cancer Treatment (FACT-G) Scores
|
89.48 score on a scale
Standard Deviation 12.92
|
90.54 score on a scale
Standard Deviation 12.98
|
90.29 score on a scale
Standard Deviation 14.49
|
90.42 score on a scale
Standard Deviation 12.58
|
88.38 score on a scale
Standard Deviation 14.82
|
90.18 score on a scale
Standard Deviation 15.40
|
89.07 score on a scale
Standard Deviation 15.39
|
88.07 score on a scale
Standard Deviation 16.87
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: The number reported in the results is based on participants.
PROMIS Pain Interference - Short Form 6b is used to measure change in Pain Interference among patients and their partners from Baseline (T1) to T2 (4 months post-T1), T3 (8-mon post-T1), and T4 (12-mon post-T1). Required by PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The pain measures the extent to which patients experience problems with pain over the past 7 days using a 5-point Likert scale. Higher scores reflect greater Pain Interference. The score value ranges between 41-78.3.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=135 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Pain From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by Patient-Reported Outcome Measurement Information System (PROMIS) Scores
|
48.88 score on a scale
Standard Deviation 9.05
|
48.38 score on a scale
Standard Deviation 9.07
|
49.25 score on a scale
Standard Deviation 9.33
|
48.37 score on a scale
Standard Deviation 8.00
|
49.68 score on a scale
Standard Deviation 9.55
|
48.53 score on a scale
Standard Deviation 9.12
|
50.09 score on a scale
Standard Deviation 10.34
|
50.34 score on a scale
Standard Deviation 9.77
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: The number reported in the results is based on participants.
FACT-G is used to measure the change in the quality of life of patients and partners from baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). Change from baseline is the post-baseline values minus the Baseline value. Functional Assessment of Cancer Therapy-General is a 27-item survey that assesses physical, social/family, emotional, and functional well-being on a 5-point Likert scale, with 0 indicating "not at all" and 4 indicating "very much" in response to item questions. The total FACT-G score is calculated as the sum of four sub-scores including physical, social/family, emotional, and functional well-being. Total scores range between 0-108. Higher scores indicated better well-being. It has also demonstrated sensitivity to change over time.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=135 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Fatigue From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by The Functional Assessment of Cancer Therapy - General (FACT-G) Scores
|
46.99 score on a scale
Standard Deviation 9.40
|
45.78 score on a scale
Standard Deviation 9.57
|
47.02 score on a scale
Standard Deviation 9.94
|
45.77 score on a scale
Standard Deviation 9.05
|
48.44 score on a scale
Standard Deviation 9.57
|
47.38 score on a scale
Standard Deviation 9.79
|
48.57 score on a scale
Standard Deviation 9.96
|
48.94 score on a scale
Standard Deviation 9.26
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: The number reported in the results is based on participants.
PROMIS Sleep Disturbance Short Form 8b is used to examine change in sleep quality of patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Required by the PROMIS scoring instrument, for all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The sleep disturbance sub-scale measured the extent to which participants experienced sleep disturbance over the past 7 days using a 5-point Likert scale. Higher scores reflect greater sleep disturbance. Score value ranges between 28.9-76.5.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=135 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Sleep Disturbance From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS Scores
|
48.82 units on a scale
Standard Deviation 9.73
|
48.54 units on a scale
Standard Deviation 9.22
|
48.58 units on a scale
Standard Deviation 9.26
|
47.43 units on a scale
Standard Deviation 9.10
|
49.96 units on a scale
Standard Deviation 9.47
|
50.08 units on a scale
Standard Deviation 10.26
|
49.59 units on a scale
Standard Deviation 9.84
|
49.79 units on a scale
Standard Deviation 10.01
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: The number reported in the results is based on participants.
PROMIS-Emotional Distress-Anxiety Short Form 7a is used to examine change in anxiety among patients and their partners from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). For all PROMS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The anxiety sub-scale of the PROMIS item bank measures the extent to which participants experience anxiety symptoms over the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 36.3 to 82.7 with higher scores reflect higher anxiety.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=135 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Anxiety From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Anxiety Short Form
|
45.15 score on a scale
Standard Deviation 8.27
|
44.46 score on a scale
Standard Deviation 8.12
|
44.32 score on a scale
Standard Deviation 8.50
|
44.11 score on a scale
Standard Deviation 7.95
|
46.09 score on a scale
Standard Deviation 9.40
|
48.04 score on a scale
Standard Deviation 9.13
|
48.53 score on a scale
Standard Deviation 9.20
|
46.83 score on a scale
Standard Deviation 8.95
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: The number reported in the results is based on participants.
PROMIS-Emotional Distress-Depression Short From 8b is used to measure the change in depression scores among patients from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Required by the PROMIS scoring instrument, for all PROMIS measurements, total raw scores are translated into T scores for each participant, where the T score rescales the raw score into a standardized T score with a mean of 50 and a standard deviation (SD) of 10. The depression sub-scale of the PROMIS item bank measures the extent to which participants experience depressive symptoms in the past 7 days using a 5-point Likert scale (1=never; 2=rarely; 3=sometimes; 4=often; and 5=always) with the total scores range from 24.7 to 63.5 with higher scores indicate greater depressive symptoms.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=135 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Depression From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Emotional Distress-Depression
|
56.50 score on a scale
Standard Deviation 7.31
|
56.31 score on a scale
Standard Deviation 6.97
|
57.28 score on a scale
Standard Deviation 7.16
|
56.54 score on a scale
Standard Deviation 7.85
|
56.92 score on a scale
Standard Deviation 7.68
|
56.48 score on a scale
Standard Deviation 7.89
|
56.66 score on a scale
Standard Deviation 7.46
|
56.63 score on a scale
Standard Deviation 8.37
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point.The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Urinary symptom scores change by time were measured using patients' self-assessed urinary symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient urinary function and bother after prostate cancer treatment. EPIC26 was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urinary Symptom Score (Patient Only)
|
67.50 score on a scale
Standard Deviation 20.45
|
79.25 score on a scale
Standard Deviation 16.41
|
82.58 score on a scale
Standard Deviation 16.18
|
80.62 score on a scale
Standard Deviation 15.99
|
68.14 score on a scale
Standard Deviation 19.25
|
79.23 score on a scale
Standard Deviation 16.28
|
80.98 score on a scale
Standard Deviation 14.74
|
80.75 score on a scale
Standard Deviation 17.47
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Bowel symptom scores change by time and were measured using patients' self-assessed bowel symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom Score (Patient Only)
|
91.90 score on a scale
Standard Deviation 14.21
|
93.89 score on a scale
Standard Deviation 14.76
|
94.20 score on a scale
Standard Deviation 10.77
|
95.23 score on a scale
Standard Deviation 10.05
|
90.03 score on a scale
Standard Deviation 13.86
|
93.23 score on a scale
Standard Deviation 12.70
|
93.62 score on a scale
Standard Deviation 13.52
|
92.44 score on a scale
Standard Deviation 13.03
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Sexual symptom scores change by time were measured using patients' self-assessed sexual symptoms subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score (Patients Only)
|
22.96 score on a scale
Standard Deviation 24.13
|
24.98 score on a scale
Standard Deviation 26.73
|
27.65 score on a scale
Standard Deviation 26.30
|
28.20 score on a scale
Standard Deviation 29.39
|
21.51 score on a scale
Standard Deviation 25.64
|
27.40 score on a scale
Standard Deviation 27.11
|
27.06 score on a scale
Standard Deviation 24.36
|
32.11 score on a scale
Standard Deviation 26.32
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point.The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Hormonal symptom scores change by time were measured using patients' self-assessed hormonal subscale of the Expanded Prostate Cancer Index Composite Short Form (EPIC 26) which is designed to evaluate patient function and bother after prostate cancer treatment. EPIC was used at Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). EPIC26 evaluates patients' functional and symptom-specific issues, including urinary, bowel, sexual, and hormonal symptoms and bother. The patient self-report contains 26 items, and the score range is 0-100. Higher scores represent fewer prostate cancer symptoms and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score (Patient Only)
|
87.57 score on a scale
Standard Deviation 14.19
|
85.24 score on a scale
Standard Deviation 18.09
|
86.69 score on a scale
Standard Deviation 13.86
|
89.41 score on a scale
Standard Deviation 11.25
|
85.62 score on a scale
Standard Deviation 15.74
|
87.44 score on a scale
Standard Deviation 14.47
|
86.95 score on a scale
Standard Deviation 15.02
|
86.13 score on a scale
Standard Deviation 16.20
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Urinary symptom scores change by time were measured using caregiver assessed urinary symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post-T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Urine Symptom Score (Partners Only)
|
76.95 score on a scale
Standard Deviation 30.19
|
86.03 score on a scale
Standard Deviation 21.28
|
90.44 score on a scale
Standard Deviation 17.42
|
86.88 score on a scale
Standard Deviation 23.19
|
78.60 score on a scale
Standard Deviation 26.51
|
87.62 score on a scale
Standard Deviation 19.88
|
86.70 score on a scale
Standard Deviation 25.99
|
83.05 score on a scale
Standard Deviation 26.27
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Bowel symptom scores change by time were measured using caregiver-assessed bowel symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Bowel Symptom (Partners Only)
|
91.13 score on a scale
Standard Deviation 20.73
|
96.78 score on a scale
Standard Deviation 9.79
|
97.79 score on a scale
Standard Deviation 9.47
|
95.00 score on a scale
Standard Deviation 13.43
|
92.45 score on a scale
Standard Deviation 16.93
|
96.00 score on a scale
Standard Deviation 14.09
|
94.15 score on a scale
Standard Deviation 17.46
|
92.05 score on a scale
Standard Deviation 17.59
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point.
Hormonal symptom scores change by time were measured using caregiver-assessed hormonal subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Hormonal Symptom Score Partners Only)
|
76.42 score on a scale
Standard Deviation 30.29
|
77.23 score on a scale
Standard Deviation 31.04
|
73.53 score on a scale
Standard Deviation 37.91
|
75.31 score on a scale
Standard Deviation 31.45
|
76.98 score on a scale
Standard Deviation 28.56
|
73.75 score on a scale
Standard Deviation 32.05
|
73.40 score on a scale
Standard Deviation 33.95
|
80.40 score on a scale
Standard Deviation 27.19
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
Sexual symptom scores change by time were measured using caregiver assessed sexual symptoms subscale of the 4-item caregiver version of the Expanded Prostate Cancer Index Composite Short Form which is designed to assess how much of a bother/burden patients' prostate cancer symptoms were for the partners themselves. EPIC-caregiver was used Baseline (T1) to T2 (4 months post T1), T3 (8 months post-T1), and T4 (12 months post-T1). The partner reported how patients' urinary and bowel, sexual, and hormonal symptoms bothered the caregivers. The score range is 0-100. Higher scores represent fewer bother partners reported and better prostate cancer-related quality of life.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Expanded Prostate Cancer Index Composite Short Form (EPIC 26) Sexual Symptom Score Partners Only)
|
65.11 score on a scale
Standard Deviation 38.26
|
66.16 score on a scale
Standard Deviation 36.12
|
64.06 score on a scale
Standard Deviation 34.74
|
61.56 score on a scale
Standard Deviation 36.44
|
63.22 score on a scale
Standard Deviation 39.64
|
60.86 score on a scale
Standard Deviation 37.82
|
66.67 score on a scale
Standard Deviation 38.06
|
65.23 score on a scale
Standard Deviation 36.24
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
The Lewis Cancer Self-Efficacy will be used to measure change in patient and partner feelings of self-efficacy in dealing with the patient's cancer diagnosis and treatment from Baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-Baseline values minus the Baseline value. Patients will rate statements about how confident they feel on a scale from 1 to 10, where higher scores indicate higher self-efficacy.
Outcome measures
| Measure |
Baseline -PERC
n=282 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=278 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale
Score change between T2 and T1
|
0.48 score on a scale
Standard Error 0.75
|
-0.75 score on a scale
Standard Error 0.74
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale
Score change between T3 and T1
|
-0.90 score on a scale
Standard Error 0.80
|
-0.76 score on a scale
Standard Error 0.76
|
—
|
—
|
—
|
—
|
—
|
—
|
|
Change in Self-efficacy Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by the Lewis Cancer Self-Efficacy Scale
Score change between T4 and T1
|
-1.00 score on a scale
Standard Error 0.82
|
-1.94 score on a scale
Standard Error 0.79
|
—
|
—
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported in the results participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
The Patient-Reported Outcomes Measurement Information System (PROMIS) 8a is a National Institute of Health-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. PROMISE is a set of measures that evaluates and monitors physical, mental, and social health. It uses a 5-point Likert scale. The scoring process involved collecting PROMIS data from participants and calculating the PROMIS score as the sum of responses to each question. Then Health Measures Scoring Service was used to calculate the PROMIS T-score - the standardized score. Specifically, PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population (T-scores have a mean of 50 and a standard deviation (SD) of 10). On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Informational Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Assessed by PROMIS-Informational Support Short Form
|
57.24 score on a scale
Standard Deviation 8.52
|
57.29 score on a scale
Standard Deviation 7.82
|
58.27 score on a scale
Standard Deviation 8.44
|
57.52 score on a scale
Standard Deviation 8.80
|
57.07 score on a scale
Standard Deviation 7.76
|
57.02 score on a scale
Standard Deviation 8.87
|
57.21 score on a scale
Standard Deviation 8.77
|
57.17 score on a scale
Standard Deviation 9.23
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point. The number reported in the results participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
The Patient-Reported Outcomes Measurement Information System (PROMIS) 8a is a National Institute of Health-funded initiative to develop and validate patient-reported outcomes (PROs) for clinical research and practice. PROMISE is a set of measures that evaluates and monitors physical, mental, and social health. It uses a 5-point Likert scale. The scoring process involved collecting PROMIS data from participants and calculating the PROMIS score as the sum of responses to each question. Then Health Measures Scoring Service was used to calculate the PROMIS T-score - the standardized score. Specifically, PROMIS uses a T-score metric in which 50 is the mean of a relevant reference population and 10 is the standard deviation (SD) of that population (T-scores have a mean of 50 and a standard deviation (SD) of 10). On the T-score metric: A score of 40 is one SD lower than the mean of the reference population; A score of 60 is one SD higher than the mean of the reference population.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Instrumental Support Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by PROMIS Instrumental Support-Short Form 8a
|
60.38 score on a scale
Standard Error 6.05
|
60.59 score on a scale
Standard Error 5.84
|
60.30 score on a scale
Standard Error 6.45
|
61.22 score on a scale
Standard Error 6.07
|
60.81 score on a scale
Standard Error 5.72
|
60.78 score on a scale
Standard Error 6.14
|
60.89 score on a scale
Standard Error 6.15
|
59.74 score on a scale
Standard Error 7.04
|
SECONDARY outcome
Timeframe: Baseline, month 4, 8, and 12Population: Subjects completed the study assessment at a time point.The number reported in the results participant flow is the dyad with the intention-to-treat principle. Each dyad contains one patient and one partner.
The appraisal of Illness scale is used to measure changes in perception of prostate cancer and related issues among patients and their partners. The Appraisal of Illness scale is a 20-item measure that uses Likert Scales ranging from 1 to 5 (very false to very true). The score range is 1-5. The higher score indicated a better cognitive appraisal of the illness the patient or partner had. The score is calculated by the Prorated mean scale scores. The formula is prorated scale score =\[SUM OF ITEM SCORES\]x\[N OF ITEMS IN SCALE\]/\[N OF ITEMS ANSWERED\]. Measurements were performed at baseline (T1) to T2 (4 months post T1), T3 (8-months post-T1), and T4 (12-months post-T1). Change from baseline is the post-baseline values minus the baseline value. Higher scores indicate better support.
Outcome measures
| Measure |
Baseline -PERC
n=141 Participants
Baseline Mean FACT-G Score
|
PERC 4-months
n=113 Participants
The mean FACT-G Score of the participant received PERC at 4 months.
|
PERC 8-months
n=104 Participants
The mean FACT-G Score of the participant received PERC at 8 months.
|
PERC 12-months
n=106 Participants
The mean FACT-G Score of the participant received PERC at 12 months.
|
Baseline Usual Care
n=139 Participants
Mean FACT-G Score of participants receive usual care at baseline.
|
Usual Care 4 Months
n=112 Participants
Mean FACT-G Score of participants receiving usual care at 4 months
|
Usual Care 8 Months
n=113 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
Usual Care 12 Months.
n=115 Participants
Mean FACT-G Score of participants receiving usual care at 8 months.
|
|---|---|---|---|---|---|---|---|---|
|
Change in Appraisal of Illness Scores From Baseline to 4-, 8-, and 12-month Post Baseline as Measured by Appraisal of Illness Scale
|
3.73 score on a scale
Standard Deviation 0.61
|
3.86 score on a scale
Standard Deviation 0.73
|
3.83 score on a scale
Standard Deviation 0.72
|
3.95 score on a scale
Standard Deviation 0.66
|
3.81 score on a scale
Standard Deviation 0.70
|
3.86 score on a scale
Standard Deviation 0.70
|
3.91 score on a scale
Standard Deviation 0.70
|
3.83 score on a scale
Standard Deviation 0.72
|
Adverse Events
PERC Program- Patients Participants
Usual Care Plus NCI Website- Patients Participants
Serious adverse events
| Measure |
PERC Program- Patients Participants
n=141 participants at risk
Prostate Cancer Education and Resources for Couples (PERC) program. Participants assigned to experimental condition will receive access to the PERC website.
Prostate Cancer Education and Resources for Couples (PERC): PERC uses mHealth technologies to dramatically increase couples' accessibility to posttreatment supportive care whenever and wherever they feel comfortable accessing it. PERC aims to improve QOL for both patients and partners by enhancing positive appraisals of illness and boosting self-efficacy, social support from multiple sources, and healthy behaviors for symptom self-management at home.
|
Usual Care Plus NCI Website- Patients Participants
n=139 participants at risk
Participants in this usual care plus NCI website group will be automatically directed to the NCI prostate cancer website after logging in to the study website homepage.
Usual care plus NCI website: The usual Care plus NCI website provides generic information about prostate cancer treatment options, research, causes, and statistics; coping resources that are not prostate cancer-specific; support from non-providers via a toll-free phone and LiveHelp Online Chat about cancer-related questions, clinical trials, and quitting smoking.
|
|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
188244007
|
1.4%
2/141 • Up to 12 months
Only Adverse Events that occurred in patient participants were reported. Patient participants' caregivers were not included in adverse event reporting.
|
0.72%
1/139 • Up to 12 months
Only Adverse Events that occurred in patient participants were reported. Patient participants' caregivers were not included in adverse event reporting.
|
|
General disorders
sudden death
|
0.71%
1/141 • Up to 12 months
Only Adverse Events that occurred in patient participants were reported. Patient participants' caregivers were not included in adverse event reporting.
|
0.00%
0/139 • Up to 12 months
Only Adverse Events that occurred in patient participants were reported. Patient participants' caregivers were not included in adverse event reporting.
|
Other adverse events
Adverse event data not reported
Additional Information
Xianming Tan, PhD
University of North Carolina Lineberger Comprehensive Cancer Center
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place