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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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

403 participants

Primary outcome timeframe

24 months

Results posted on

2024-04-02

Participant Flow

Participant milestones

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

Baseline characteristics by cohort
Measure
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
Intervention Evaluation Control Group
n=197 Participants
Surveys at 3 month intervals Control: usual care, surveys every 3 months
Age, Continuous
64 years
STANDARD_DEVIATION 6.7 • n=7 Participants
63.5 years
STANDARD_DEVIATION 6.6 • n=5 Participants
62.9 years
STANDARD_DEVIATION 6.6 • n=5 Participants
Sex: Female, Male
Female
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Sex: Female, Male
Male
204 Participants
n=7 Participants
401 Participants
n=5 Participants
197 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=7 Participants
2 Participants
n=5 Participants
2 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=7 Participants
0 Participants
n=5 Participants
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
13 Participants
n=7 Participants
22 Participants
n=5 Participants
9 Participants
n=5 Participants
Race (NIH/OMB)
White
186 Participants
n=7 Participants
365 Participants
n=5 Participants
179 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
2 Participants
n=7 Participants
8 Participants
n=5 Participants
6 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
3 Participants
n=7 Participants
4 Participants
n=5 Participants
1 Participants
n=5 Participants

PRIMARY outcome

Timeframe: 24 months

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.

Outcome measures

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 months

The 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

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-up

Population: 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

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-up

Population: 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

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

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Intervention Evaluation Test Group

Serious events: 0 serious events
Other events: 0 other events
Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Gudrun Kilian

University of Minnesota

Phone: 612-626-9568

Results disclosure agreements

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