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Open Access Study protocol

Improving sexual health in men with prostate cancer: randomised controlled trial of exercise and psychosexual therapies

Prue Cormie1*, Suzanne K Chambers12346, Robert U Newton1, Robert A Gardiner156, Nigel Spry178, Dennis R Taaffe19, David Joseph178, M Akhlil Hamid110, Peter Chong11, David Hughes12, Kyra Hamilton2 and Daniel A Galvão1

Author Affiliations

1 Edith Cowan University Health and Wellness Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027, Australia

2 Griffith Health Institute, Griffith University, Southport, Australia

3 Cancer Council Queensland, Brisbane, Australia

4 Prostate Cancer Foundation of Australia, Sydney, Australia

5 Department of Urology, Royal Brisbane and Women’s Hospital, Brisbane, Australia

6 Centre for Clinical Research, The University of Queensland, Brisbane, Australia

7 Department of Radiation Oncology, Sir Charles Gairdner Hospital, Nedlands, Australia

8 Faculty of Medicine, University of Western Australia, Nedlands, Australia

9 School of Environmental and Life Sciences, University of Newcastle, Ourimbah, Australia

10 Department of Urology, Royal Perth Hospital, Perth, Western Australia, Australia

11 Lake Macquarie Urology, Newcastle, New South Wales, Australia

12 Bangalow Community Health Centre, Bangalow, New South Wales, Australia

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BMC Cancer 2014, 14:199  doi:10.1186/1471-2407-14-199

Published: 18 March 2014

Abstract

Background

Despite being a critical survivorship care issue, there is a clear gap in current knowledge of the optimal treatment of sexual dysfunction in men with prostate cancer. There is sound theoretical rationale and emerging evidence that exercise may be an innovative therapy to counteract sexual dysfunction in men with prostate cancer. Furthermore, despite the multidimensional aetiology of sexual dysfunction, there is a paucity of research investigating the efficacy of integrated treatment models. Therefore, the purpose of this study is to: 1) examine the efficacy of exercise as a therapy to aid in the management of sexual dysfunction in men with prostate cancer; 2) determine if combining exercise and brief psychosexual intervention results in more pronounced improvements in sexual health; and 3) assess if any benefit of exercise and psychosexual intervention on sexual dysfunction is sustained long term.

Methods/Design

A three-arm, multi-site randomised controlled trial involving 240 prostate cancer survivors will be implemented. Participants will be randomised to: 1) ‘Exercise’ intervention; 2) ‘Exercise + Psychosexual’ intervention; or 3) ‘Usual Care’. The Exercise group will receive a 6-month, group based, supervised resistance and aerobic exercise intervention. The Exercise + Psychosexual group will receive the same exercise intervention plus a brief psychosexual self-management intervention that addresses psychological and sexual well-being. The Usual Care group will maintain standard care for 6 months. Measurements for primary and secondary endpoints will take place at baseline, 6 months (post-intervention) and 1 year follow-up. The primary endpoint is sexual health and secondary endpoints include key factors associated with sexual health in men with prostate cancer.

Discussion

Sexual dysfunction is one of the most prevalent and distressing consequences of prostate cancer. Despite this, very little is known about the management of sexual dysfunction and current health care services do not adequately meet sexual health needs of survivors. This project will examine the potential role of exercise in the management of sexual dysfunction and evaluate a potential best-practice management approach by integrating pharmacological, physiological and psychological treatment modalities to address the complex and multifaceted aetiology of sexual dysfunction following cancer.

Trial registration

Australian New Zealand Clinical Trials Registry ACTRN12613001179729.

Keywords:
Prostate cancer; Sexual health; Erectile dysfunction; Exercise; Resistance training; Aerobic exercise; Psychosexual support; Self-management