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Randomized Controlled Trial
. 2017 Oct 2;17(1):664.
doi: 10.1186/s12885-017-3652-3.

TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial

D Wittmann  1 , A Mehta  2 , L Northouse  3 , R Dunn  3 , T Braun  3 , A Duby  3 , L An  3 , L Arab  4 , R Bangs  3 , S Bober  5 , J Brandon  3 , M Coward  6 , M Dunn  6 , M Galbraith  7 , M Garcia  8 , J Giblin  2 , M Glode  7 , B Koontz  9 , A Lowe  10 , S Mitchell  3 , J Mulhall  11 , C Nelson  11 , K Paich  12 , C Saigal  4 , T Skolarus  3   13 , J Stanford  14   15 , T Walsh  15 , C E Pollack  16
Affiliations
Randomized Controlled Trial

TrueNTH sexual recovery study protocol: a multi-institutional collaborative approach to developing and testing a web-based intervention for couples coping with the side-effects of prostate cancer treatment in a randomized controlled trial

D Wittmann et al. BMC Cancer. .

Abstract

Background: Over half of men who receive treatment for prostate suffer from a range of sexual problems that affect negatively their sexual health, sexual intimacy with their partners and their quality of life. In clinical practice, however, care for the sexual side effects of treatment is often suboptimal or unavailable. The goal of the current study is to test a web-based intervention to support the recovery of sexual intimacy of prostate cancer survivors and their partners after treatment.

Methods: The study team developed an interactive, web-based intervention, tailored to type of treatment received, relationship status (partnered/non-partnered) and sexual orientation. It consists of 10 modules, six follow the trajectory of the illness and four are theme based. They address sexual side effects, rehabilitation, psychological impacts and coaching for self-efficacy. Each includes a video to engage participants, psychoeducation and activities completed by participants on the web. Tailored strategies for identified concerns are sent by email after each module. Six of these modules will be tested in a randomized controlled trial and compared to usual care. Men with localized prostate cancer with partners will be recruited from five academic medical centers. These couples (N = 140) will be assessed prior to treatment, then 3 months and 6 months after treatment. The primary outcome will be the survivors' and partners' Global Satisfaction with Sex Life, assessed by a Patient Reported Outcome Measure Information Systems (PROMIS) measure. Secondary outcomes will include interest in sex, sexual activity, use of sexual aids, dyadic coping, knowledge about sexual recovery, grief about the loss of sexual function, and quality of life. The impact of the intervention on the couple will be assessed using the Actor-Partner Interaction Model, a mixed-effects linear regression model able to estimate both the association of partner characteristics with partner and patient outcomes and the association of patient characteristics with both outcomes.

Discussion: The web-based tool represents a novel approach to addressing the sexual health needs of prostate cancer survivors and their partners that-if found efficacious-will improve access to much needed specialty care in prostate cancer survivorship.

Trial registration: Clinicaltrials.gov registration # NCT02702453 , registered on March 3, 2016.

Keywords: Prostate cancer sexual recovery cancer survivorship intervention.

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Conflict of interest statement

Ethics approval and consent to participate

The study was approved by the following institutional review boards:

University of Michigan: Medical School Institutional Review Board (IRBMED).

Emory University: Institutional Review Board (IRB).

Memorial Sloan Kettering Cancer Center: Institutional Review Board/Privacy Board-B.

University of California Los Angeles: Office of Human Research Protection Program (OHRPP).

Johns Hopkins University: Office of Human Subjects Research Institutional Review Boards.

All participants must sign informed consent before enrolling in the study.

Consent for publication

Consent for publication is not needed as no individual patient data or images are involved in this research.

Competing interests

  1. ◦ Dr. Wittmann has Movember Foundation research funding.

  2. ◦ Dr. Coward is a Consultant to Coloplast Corporation

  3. ◦ Dr. Koontz receives research funding from Janssen Pharmaceuticals and royalties from UpToDate®. She acts on an Advisory Board for Blue Earth Pharmaceuticals

  4. ◦ Dr. Lowe is the Chief Executive Officer of Prostate Cancer Foundation of Australia and consults to the Menzies Health Institute Queensland, Griffith University and ANZUP Cancer Trails Group Limited

  5. ◦ Dr. Mulhall has research funding from Pfizer, Inc. and is a Consultant to the following entitites: Eli Lilly and Co., Alliance for Fertility Preservation, Nexmed, Absorption Pharmaceuticals, AMS, Meda, Vivus, and has a leadership role with the Association of Peyronie’s Disease Advocates

  6. ◦ Ms. Paich is a US Project Manager for TrueNTH Movember Foundation

  7. ◦ Dr. Skolarus is supported by a VA HSR&D Career Development Award - 2 (CDA 12–171) and receives royalties from UpToDate®.

  8. ◦ Dr. Saigal is WiserCare Cofounder and Board Member

  9. ◦ Dr. Walsh is a Consultant to Coloplast Corporation and Boston Scientific

  10. ◦ All other authors have no relevant disclosures

  11. ◦ The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Tailored web-based intervention to support couples’ sexual recovery after treatment for localized prostate cancer (RCT of 6 modules in a pre-treatm6nt to 6-month post-treatment time-frame)
Fig. 2
Fig. 2
Study progression
See this image and copyright information in PMC

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