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

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

Study Overview

• Status: Completed
• Conditions: Prostatic Neoplasm
• Intervention / Treatment: Behavioral: Control; Behavioral: Restore Rehabilitation Program

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.

• Study Type: Interventional
• Enrollment (Actual): 403
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Minnesota
    • Minneapolis, Minnesota, United States, 55454
      • University of Minnesota Twin Cities Campus

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Gay or Bisexual Men, defined as a biological adult male, who by self-report, has had sex with a man.
2. 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.
3. 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.
4. Internet-using
5. Living in the US (including territories) as measured by valid US zip code
6. 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:

1. No Nerve Sparing and Salvage therapy.
2. Medical contraindications as determined by investigators at screening
3. Heavy smoking: more than 10 cigarettes, cigars, e-cigarettes, snuff pipe or similar product on an average day (screened over last 7 days)
4. Heavy alcohol use: more than 4 drinks per day, on two or more days, last 7 days
5. Participation is limited to English speakers/readers since intervention materials and surveys are in English.
6. Cognitive impairment.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention Evaluation Control Group; Surveys at 3 month intervals	Behavioral: Control; usual care, surveys every 3 months
Experimental: Intervention Evaluation Test Group; 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	Behavioral: Restore Rehabilitation Program; Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Minnesota
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: B. Simon Rosser, PhD, University of Minnesota

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2019
• Primary Completion (Actual): September 15, 2021
• Study Completion (Actual): June 20, 2023

Study Registration Dates

• First Submitted: October 30, 2017
• First Submitted That Met QC Criteria: November 10, 2017
• First Posted (Actual): November 17, 2017

Study Record Updates

• Last Update Posted (Actual): April 2, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Erectile Dysfunction
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Urogenital Diseases; Male Urogenital Diseases; Genital Diseases, Male; Genital Diseases; Prostatic Neoplasms
• Other Study ID Numbers: SPH-2018-26507; 1R01CA218657-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No