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N/A Completed N=403 Randomized Single-blind Supportive Care

Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors

Source: ClinicalTrials.gov NCT03343093 ↗
Enrolled (actual)
403
Serious AEs
0.0%
Results posted
Apr 2024
Primary outcomePrimary: Urinary Function Scores — 80.1; 81.4 Scores on a scale (0-100)

Summary

Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.

Outcome Measures

OutcomeResultp-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

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.
View full record on ClinicalTrials.gov →

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. Informational only — not medical advice.

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