title: Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: study protocol for a pilot randomised controlled trial.
abstract: BACKGROUND
  Men who undergo surgery for prostate cancer frequently experience significant side-effects including urinary and sexual dysfunction. These difficulties can lead to anxiety, depression and reduced quality of life. Many partners also experience psychological distress. An additional impact can be on the couple relationship, with changes to intimacy, and unmet psychosexual supportive needs in relation to sexual recovery and rehabilitation. The aim of this exploratory randomised controlled trial pilot study is to determine the feasibility and acceptability of a novel family-relational-psychosexual intervention to support intimacy and reduce distress among couples following prostate cancer surgery and to estimate the efficacy of this intervention.
  
  
  METHODS
  The intervention will comprise six sessions of psychosexual and relationship support delivered by experienced couple-support practitioners. Specialist training in delivering the intervention will be provided to practitioners and they will be guided by a detailed treatment manual based on systemic principles. Sixty-eight couples will be randomised to receive either the intervention or standard care (comprising usual follow-up hospital appointments). A pre-test, post-test design will be used to test the feasibility of the intervention (baseline, end of intervention and six-month follow-up) and its acceptability to couples and healthcare professionals (qualitative interviews). Both individual and relational outcome measures will assess sexual functioning, anxiety and depression, couple relationship, use of health services and erectile dysfunction medication/technologies. An economic analysis will estimate population costs of the intervention, compared to usual care, using simple modelling to evaluate the affordability of the intervention.
  
  
  CONCLUSIONS
  Given the increasing incidence and survival of post-operative men with prostate cancer, it is timely and appropriate to determine the feasibility of a definitive trial through a pilot randomised controlled trial of a family-relational-psychosexual intervention for couples. The study will provide evidence about the components of a couple-based intervention, its acceptability to patients and healthcare professionals, and its influence on sexual and relational functioning. Data from this study will be used to calculate sample sizes required for any definitive trial.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT01842438.Registration date: 24 April 2013; Randomisation of first patient: 13 May 2013.
authors.forename: Jane M
authors.initials: JM
authors.lastname: Robertson
authors.forename: Gerard J
authors.initials: GJ
authors.lastname: Molloy
authors.forename: Prasad R
authors.initials: PR
authors.lastname: Bollina
authors.forename: Daniel M
authors.initials: DM
authors.lastname: Kelly
authors.forename: S Alan
authors.initials: SA
authors.lastname: McNeill
authors.affiliation: Cancer Care Research Centre, School of Nursing, Midwifery and Health, University of Stirling, Stirling FK9 4LA, UK. elizabeth.forbat@stir.ac.uk.
authors.forename: Liz
authors.initials: L
authors.lastname: Forbat
mesh_terms: D002985:Clinical Protocols; D003362:Cost-Benefit Analysis; D019546:Couples Therapy / Q000191:economics; D005240:Feasibility Studies; D005260:Female; D017048:Health Care Costs; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011471:Prostatic Neoplasms / Q000191:economics / Q000601:surgery*; D012107:Research Design; D012606:Scotland; D012725:Sexual Behavior; D012735:Sexual Dysfunction, Physiological / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000523:psychology / Q000628:therapy*; D020018:Sexual Dysfunctions, Psychological / Q000175:diagnosis / Q000191:economics / Q000209:etiology / Q000628:therapy*; D012747:Sexual Partners / Q000523:psychology*; D018454:Spouses / Q000523:psychology*; D013997:Time Factors; D016896:Treatment Outcome; D013521:Urologic Surgical Procedures, Male / Q000009:adverse effects* / Q000191:economics