Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Primary Purpose
Prostatic Neoplasm
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Restore Rehabilitation Program
Control
Sponsored by
About this trial
This is an interventional supportive care trial for Prostatic Neoplasm focused on measuring Erectile Dysfunction
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.
Sites / Locations
- University of Minnesota Twin Cities Campus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Intervention Evaluation Control Group
Intervention Evaluation Test Group
Arm Description
Surveys at 3 month intervals
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
Outcomes
Primary Outcome Measures
Urinary Incontinence
self- reported instances of urinary incontinence
Erectile Dysfunction
Self-reported instances of erectile dysfunction
Secondary Outcome Measures
Full Information
NCT ID
NCT03343093
First Posted
October 30, 2017
Last Updated
June 21, 2023
Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT03343093
Brief Title
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Official Title
Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
September 15, 2021 (Actual)
Study Completion Date
June 20, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
Collaborators
National Cancer Institute (NCI)
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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 severely under-researched. Because gay sex differs from vaginal sex, physiologically; the results from 614 studies focused on heterosexual men likely do not generalize to gay and bisexual men(GBM) with prostate cancer. There have been no rehabilitation studies specific to GBM survivors of prostate cancer, so clinicians have no relevant studies to inform best practice with their GBM patients.
Second, most prostate cancer studies have tested one or rehabilitation components. The investigators will conduct the first treatment study of a state of clinical practice comprehensive rehabilitation program on GBM's quality of life, including on both urinary and sexual function and bother measures.
Third, almost all prostate cancer studies have focused on men recently treated for prostate cancer.
The long-term objective of this research is to improve the health of gay and bisexual survivors of Prostate cancer and to provide an evidence base for rehabilitation. The Investigators will develop an online rehabilitation program tailored for GBM that addresses both the sexual and urinary effects of prostate cancer treatment. In addition, The Investigators will conduct a comparative recruitment study to identify best methods to recruit 450 GBM with Prostate cancer.
Finally, the Investigators will evaluate the effects of the tailored rehabilitation program on sexual and urinary outcomes. The Investigators will conduct a 24 month, randomized controlled trial of structured rehabilitation versus routine care. The Investigators will study both GBM recently treated (last 2 years) and GBM post-treatment (2+ years), using a stratified design. This randomized control trial will identify whether a structured rehabilitation program is effective in addressing the major sexual and urinary problems caused by Prostate cancer treatment. As the first treatment study to focus on GBM with Prostate cancer (and also on oral and anal sex), it addresses a long-standing health disparity.
The study has high potential to transform rehabilitation for GBM with Prostate cancer, provide a critical evidence base for clinicians, and inform rehabilitation outcomes for all Prostate cancer survivors.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostatic Neoplasm
Keywords
Erectile Dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
403 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention Evaluation Control Group
Arm Type
Experimental
Arm Description
Surveys at 3 month intervals
Arm Title
Intervention Evaluation Test Group
Arm Type
Experimental
Arm 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
Intervention Type
Behavioral
Intervention Name(s)
Restore Rehabilitation Program
Intervention Description
Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
Intervention Type
Behavioral
Intervention Name(s)
Control
Intervention Description
usual care, surveys every 3 months
Primary Outcome Measure Information:
Title
Urinary Incontinence
Description
self- reported instances of urinary incontinence
Time Frame
24 months
Title
Erectile Dysfunction
Description
Self-reported instances of erectile dysfunction
Time Frame
24 months
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Male bodied persons at risk of prostate cancer
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
B. Simon Rosser, PhD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota Twin Cities Campus
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
34348045
Citation
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.
Results Reference
derived
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Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
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