Clinical trial · Interventional
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
NCT03343093CI-TRIAL-00075625completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostatic Neoplasm | Prostate Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Control | Behavioral | — | UNRESOLVED |
| Restore Rehabilitation Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Intervention Evaluation Control Group
- description
- Surveys at 3 month intervals
- interventionNames
- Behavioral: Control
- type
- EXPERIMENTAL
- label
- Intervention Evaluation Test Group
- description
- 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
- interventionNames
- Behavioral: Restore Rehabilitation Program
Primary outcomes (4)
- measure
- Urinary Function Scores
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Gay or Bisexual Men, defined as a biological adult male, who by self-report, has had sex with a man. 2. 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. 3. 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. 4. Internet-using 5. Living in the US (including territories) as measured by valid US zip code 6. 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: 1. No Nerve Sparing and Salvage therapy. 2. Medical contraindications as determined by investigators at screening 3. Heavy smoking: more than 10 cigarettes, cigars, e-cigarettes, snuff pipe or similar product on an average day (screened over last 7 days) 4. Heavy alcohol use: more than 4 drinks per day, on two or more days, last 7 days 5. Participation is limited to English speakers/readers since intervention materials and surveys are in English. 6. Cognitive impairment.
References
Publications (1)
- DERIVEDRosser BRS, Polter EJ, Chandiramani N, Cahill S, Wheldon CW, Konety BR, Ryan CJ, Haggart R, Kapoor A. Acceptability and Feasibility of Collecting Sexual Orientation and Expanded Gender Identity Data in Urology and Oncology Clinics. LGBT Health. 2021 Aug-Sep;8(6):420-426. doi: 10.1089/lgbt.2020.0256. Epub 2021 Aug 4. PMID 34348045