N/A
N=403
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Prostatic Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT03343093 ↗Enrolled (actual)
403
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcome: Primary: Urinary Function Scores — 80.1; 81.4 Scores on a scale (0-100)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Restore Rehabilitation Program (Behavioral); Control (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Male
- Sponsor
- University of Minnesota
- Primary completion
- Sep 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Urinary Function Scores |
80.1; 81.4 | — |
| PRIMARY Sexual Functioning Scores |
37.5; 36.7 | — |
| PRIMARY Intervention Acceptability |
156 | — |
| PRIMARY Intervention Feasibility |
189 | — |
Summary
Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.
Eligibility Criteria
Inclusion Criteria
- Gay or Bisexual Men, defined as a biological adult male, who by self-report, has had sex with a man.
- Treated for prostate cancer, defined as (i) having been diagnosed with prostate cancer and measured by being able to report a Prostate- Specific Antigen and Gleason score; and (ii) treated by radical prostatectomy, radiation or systemically.
- Has recent problems with sexual and/or urinary function, by self-report. This is measured by a screener item(s) asking the enrollee to describe their current function (last 4 weeks) and validated by nurse interview.
- Internet-using
- Living in the US (including territories) as measured by valid US zip code
- A unique, validated individual, as measured by our published de-duplication and cross-validation protocols,230-232 and confirmed by video or phone interview.
Exclusion Criteria
- No Nerve Sparing and Salvage therapy.
- Medical contraindications as determined by investigators at screening
- Heavy smoking: more than 10 cigarettes, cigars, e-cigarettes, snuff pipe or similar product on an average day (screened over last 7 days)
- Heavy alcohol use: more than 4 drinks per day, on two or more days, last 7 days
- Participation is limited to English speakers/readers since intervention materials and surveys are in English.
- Cognitive impairment.
Data sourced from ClinicalTrials.gov (NCT03343093). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.