Please use this identifier to cite or link to this item: http://hdl.handle.net/1893/20436
Appears in Collections:Faculty of Health Sciences and Sport Journal Articles
Peer Review Status: Refereed
Title: Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: Study protocol for a pilot randomised controlled trial
Author(s): Robertson, Jane
Molloy, Gerard
Bollina, Prasad R
Kelly, Daniel
McNeill, S Alan
Forbat, Liz
Contact Email: elizabeth.forbat1@stir.ac.uk
Keywords: Adjustment
Communication
Counselling
Couple
Functioning
Intervention
Prostate cancer
Psychological
Quality of life
Relationship
Sexual
Issue Date: May-2014
Date Deposited: 5-Jun-2014
Citation: Robertson J, Molloy G, Bollina PR, Kelly D, McNeill SA & Forbat L (2014) Exploring the feasibility and acceptability of couple-based psychosexual support following prostate cancer surgery: Study protocol for a pilot randomised controlled trial. Trials, 15, Art. No.: 183. https://doi.org/10.1186/1745-6215-15-183
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/Design: 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. Discussion: 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. Trial registration: ClinicalTrials.gov Identifier: NCT01842438. Registration date: 24 April 2013; Randomisation of first patient: 13 May 2013
DOI Link: 10.1186/1745-6215-15-183
Rights: © 2014 Robertson et al.; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly credited. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
Licence URL(s): http://creativecommons.org/licenses/by/2.0/

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