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



Status:Recruiting
Conditions:Prostate Cancer
Therapuetic Areas:Oncology
Healthy:No
Age Range:18 - Any
Updated:1/25/2019
Start Date:January 1, 2019
End Date:August 31, 2022
Contact:Chris J Hoefer
Email:hoefer@umn.edu
Phone:612-625-4799

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Development and evaluation of an online intervention addressing sexual functioning in MSM
after prostate cancer treatment.

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.

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.
We found this trial at
1
site
Minneapolis, Minnesota 55455
Phone: 612-625-4799
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Minneapolis, MN
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