Status:
COMPLETED
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Lead Sponsor:
University of Minnesota
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Prostatic Neoplasm
Eligibility:
MALE
18+ years
Phase:
NA
Brief Summary
Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.
Detailed Description
This study advances research in three areas. First, prostate cancer is the second most common cancer among gay, bisexual, and other men who have sex with men with documented disparities, yet it is se...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 20 2023
Estimated Enrollment :
403 Patients enrolled
Trial Details
Trial ID
NCT03343093
Start Date
January 1 2019
End Date
June 20 2023
Last Update
April 2 2024
Active Locations (1)
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1
University of Minnesota Twin Cities Campus
Minneapolis, Minnesota, United States, 55454