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

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ClinicalTrials.gov Identifier: NCT03343093
Recruitment Status : Not yet recruiting
First Posted : November 17, 2017
Last Update Posted : November 17, 2017
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Chris Hoefer, University of Minnesota - Clinical and Translational Science Institute

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

Condition or disease Intervention/treatment Phase
Prostatic Neoplasm Behavioral: Restore Rehabilitation Program Behavioral: Control Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 450 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Restore: Improving Sexual Outcomes of Gay and Bisexual Prostate Cancer Survivors
Estimated Study Start Date : January 1, 2019
Estimated Primary Completion Date : July 1, 2022
Estimated Study Completion Date : August 31, 2022


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




Primary Outcome Measures :
  1. Urinary Incontinence [ Time Frame: 24 months ]
    self- reported instances of urinary incontinence

  2. Erectile Dysfunction [ Time Frame: 24 months ]
    Self-reported instances of erectile dysfunction



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Male bodied persons at risk of prostate cancer
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03343093


Contacts
Contact: Chris J Hoefer 612-625-4799 hoefer@umn.edu
Contact: Gudrun Kilian 612-626-8148 kilian@umn.edu

Sponsors and Collaborators
University of Minnesota, MN
National Cancer Institute (NCI)
Investigators
Principal Investigator: B. Simon Rosser, PhD University of Minnesota - Clinical and Translational Science Institute

Responsible Party: Chris Hoefer, Research Project Coordinator, University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03343093     History of Changes
Other Study ID Numbers: 1R01CA218657-01 ( U.S. NIH Grant/Contract )
1R01CA218657-01 ( U.S. NIH Grant/Contract )
First Posted: November 17, 2017    Key Record Dates
Last Update Posted: November 17, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Chris Hoefer, University of Minnesota - Clinical and Translational Science Institute:
Erectile Dysfunction

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases