title: Improving sexual health in men with prostate cancer: randomised controlled trial of exercise and psychosexual therapies.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  Australian New Zealand Clinical Trials Registry ACTRN12613001179729.
authors.affiliation: Edith Cowan University Health and Wellness Institute, Edith Cowan University, 270 Joondalup Drive, Joondalup, WA 6027, Australia. p.cormie@ecu.edu.au.
authors.forename: Prue
authors.initials: P
authors.lastname: Cormie
authors.forename: Suzanne K
authors.initials: SK
authors.lastname: Chambers
authors.forename: Robert U
authors.initials: RU
authors.lastname: Newton
authors.forename: Robert A
authors.initials: RA
authors.lastname: Gardiner
authors.forename: Nigel
authors.initials: N
authors.lastname: Spry
authors.forename: Dennis R
authors.initials: DR
authors.lastname: Taaffe
authors.forename: David
authors.initials: D
authors.lastname: Joseph
authors.forename: M Akhlil
authors.initials: MA
authors.lastname: Hamid
authors.forename: Peter
authors.initials: P
authors.lastname: Chong
authors.forename: David
authors.initials: D
authors.lastname: Hughes
authors.forename: Kyra
authors.initials: K
authors.lastname: Hamilton
authors.forename: Daniel A
authors.initials: DA
authors.lastname: Galvão
mesh_terms: D003131:Combined Modality Therapy / Q000379:methods; D005081:Exercise Therapy; D006801:Humans; D008297:Male; D011471:Prostatic Neoplasms / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D011788:Quality of Life / Q000523:psychology; D060728:Reproductive Health; D012648:Self Care; D012735:Sexual Dysfunction, Physiological / Q000628:therapy*; D020018:Sexual Dysfunctions, Psychological / Q000628:therapy*; D012944:Social Support; D016896:Treatment Outcome