Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
2 other identifiers
interventional
403
1 country
1
Brief Summary
Development and evaluation of an online intervention addressing sexual functioning in gay and bisexual men (GBM) after prostate cancer treatment.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2019
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 30, 2017
CompletedFirst Posted
Study publicly available on registry
November 17, 2017
CompletedStudy Start
First participant enrolled
January 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 20, 2023
CompletedResults Posted
Study results publicly available
April 2, 2024
CompletedApril 2, 2024
March 1, 2024
2.7 years
October 30, 2017
October 23, 2023
March 5, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Urinary Function Scores
The Urinary Function domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of urinary symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of urinary symptoms.
24 months
Sexual Functioning Scores
The Sexual Functioning domain of the Expanded Prostate Cancer Index Composite (EPIC-50) scale was used to assess the frequency of sexual functioning symptoms. Scores range from 0 to 100, with higher scores indicating less frequency of sexual functioning symptoms.
24 months
Intervention Acceptability
Acceptability was measured by how much intervention group participants would recommend the intervention to a friend (if he had prostate cancer). This single Likert-type item has five response options from 1=strongly agree to 5= strongly disagree. Acceptability will be measured by adding those who answered 1=strongly agree or 2=agree on this item.
3-month follow-up
Intervention Feasibility
Feasibility will be measured by monitoring the number of intervention participants who could access the intervention webpage at least once within the first three months of the study.
3-month follow-up
Study Arms (2)
Intervention Evaluation Control Group
EXPERIMENTALSurveys at 3 month intervals
Intervention Evaluation Test Group
EXPERIMENTALWe will evaluate the effects of an educational, tailored, online rehabilitation program addressing sexual and urinary outcomes after treatment by surveying at 3 month intervals
Interventions
Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Minnesotalead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Minnesota Twin Cities Campus
Minneapolis, Minnesota, 55454, United States
Related Publications (1)
Rosser 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: 34348045DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Gudrun Kilian
- Organization
- University of Minnesota
Study Officials
- PRINCIPAL INVESTIGATOR
B. Simon Rosser, PhD
University of Minnesota
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 30, 2017
First Posted
November 17, 2017
Study Start
January 1, 2019
Primary Completion
September 15, 2021
Study Completion
June 20, 2023
Last Updated
April 2, 2024
Results First Posted
April 2, 2024
Record last verified: 2024-03
Data Sharing
- IPD Sharing
- Will not share