Trial Outcomes & Findings for Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors (NCT NCT03343093)
NCT ID: NCT03343093
Last Updated: 2024-04-02
Results Overview
The Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms.
COMPLETED
NA
403 participants
24 months
2024-04-02
Participant Flow
Participant milestones
| Measure |
Intervention Evaluation Control Group
Surveys at 3 month intervals
Control: usual care, surveys every 3 months
|
Intervention Evaluation Test Group
We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
204
|
|
Overall Study
COMPLETED
|
180
|
175
|
|
Overall Study
NOT COMPLETED
|
19
|
29
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Baseline characteristics by cohort
| Measure |
Intervention Evaluation Control Group
n=197 Participants
Surveys at 3 month intervals
Control: usual care, surveys every 3 months
|
Intervention Evaluation Test Group
n=204 Participants
We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
|
Total
n=401 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62.9 years
STANDARD_DEVIATION 6.6 • n=99 Participants
|
64 years
STANDARD_DEVIATION 6.7 • n=107 Participants
|
63.5 years
STANDARD_DEVIATION 6.6 • n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
197 Participants
n=99 Participants
|
204 Participants
n=107 Participants
|
401 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
179 Participants
n=99 Participants
|
186 Participants
n=107 Participants
|
365 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
8 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: 24 monthsThe Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms.
Outcome measures
| Measure |
Intervention Evaluation Control Group
n=197 Participants
Surveys at 3 month intervals
Control: usual care, surveys every 3 months
|
Intervention Evaluation Test Group
n=204 Participants
We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
|
|---|---|---|
|
Urinary Function Scores
|
80.1 Scores on a scale (0-100)
Interval 78.1 to 82.2
|
81.4 Scores on a scale (0-100)
Interval 79.4 to 83.5
|
PRIMARY outcome
Timeframe: 24 monthsThe Sexual Functioning domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of sexual functioning symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of sexual functioning symptoms.
Outcome measures
| Measure |
Intervention Evaluation Control Group
n=197 Participants
Surveys at 3 month intervals
Control: usual care, surveys every 3 months
|
Intervention Evaluation Test Group
n=204 Participants
We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
|
|---|---|---|
|
Sexual Functioning Scores
|
37.5 Scores on a scale (0-100)
Interval 34.7 to 40.3
|
36.7 Scores on a scale (0-100)
Interval 33.9 to 39.4
|
PRIMARY outcome
Timeframe: 3-month follow-upPopulation: Percent frequencies of those rating the intervention as acceptable
Acceptability was measured by how much intervention group participants would recommend the intervention to a friend (if he had prostate cancer). This single Likert-type item has five response options from 1=strongly agree to 5= strongly disagree. Acceptability will be measured by adding those who answered 1=strongly agree or 2=agree on this item.
Outcome measures
| Measure |
Intervention Evaluation Control Group
n=183 Participants
Surveys at 3 month intervals
Control: usual care, surveys every 3 months
|
Intervention Evaluation Test Group
We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
|
|---|---|---|
|
Intervention Acceptability
|
156 Participants
|
—
|
PRIMARY outcome
Timeframe: 3-month follow-upPopulation: Percent participants who where able to access the intervention at least once.
Feasibility will be measured by monitoring the number of intervention participants who could access the intervention webpage at least once within the first three months of the study.
Outcome measures
| Measure |
Intervention Evaluation Control Group
n=204 Participants
Surveys at 3 month intervals
Control: usual care, surveys every 3 months
|
Intervention Evaluation Test Group
We will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Restore Rehabilitation Program: Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
|
|---|---|---|
|
Intervention Feasibility
|
189 Participants
|
—
|
Adverse Events
Intervention Evaluation Control Group
Intervention Evaluation Test Group
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place