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

Prostatic Neoplasm Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03343093
• Other study ID #: SPH-2018-26507
• Secondary ID: 1R01CA218657-01
• Status: Completed
• Phase: N/A
• Start date: January 1, 2019
• Est. completion date: June 20, 2023

Study information

• Verified date: March 2024
• Source: University of Minnesota
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: June 20, 2023
• Est. primary completion date: September 15, 2021
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Prostatic Neoplasm
• Prostatic Neoplasms

Intervention

Behavioral:
• Restore Rehabilitation Program
Multi-component, structured, biopsychosocial, online interactive program to address the sexual and urinary effects of prostate cancer treatment
• Control
usual care, surveys every 3 months

Locations

Country	Name	City	State
United States	University of Minnesota Twin Cities Campus	Minneapolis	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
University of Minnesota	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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