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

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

Prostatic Neoplasm

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

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

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.
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.

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