Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery.
Methods This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and incorporates three main components: shoulder-specific exercises targeting range of movement and strength; general physical activity and behavioural strategies to encourage adherence and support exercise behaviour. The primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions.
Discussion The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation.
Protocol version Version 2.1; dated 11 January 2017
Trial registration number ISRCTN35358984; Pre-results.
- breast surgery
- clinical trials
- rehabilitation medicine
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Data Monitoring Committee Professor Malcolm Reed (Chair), Dr Rhian Gabe, Dr Matthew Maddocks.
Trial Steering Committee Professor Steven Duffy (Chair), Dr Anna Kirby, Dr Karen Robb. We dedicate this article to Professor Adele Frances (Deceased) who served on the PROSPER TSC from 2015 to 2016.
Contributors JB obtained study funding with support from SEL, EW, RL, SP and AMT. JB, SEL, EW, CL, RL, AMT, LB, SR and SP participated in the design of the study. EJW and LB coordinate study administration, acquisition of trial data and administrative support (CT/LC). PM will undertake statistical analysis, under direction of RL, senior trial statistician. AC is responsible for health economic analysis, supported by SP, senior health economist. JB and HR drafted the manuscript. All authors critically revised the manuscript for intellectual content and approved the final manuscript. This trial protocol is published on behalf of the PROSPER Study Group.
Funding The PROSPER trial is funded by the National Institute of Health Research Technology Assessment Programme (NiHR HTA), project number 13/84/10. The views expressed in this publication are those of the authors and not necessarily those of the NIHR or Department of Health. This project benefited from facilities funded by Birmingham Science City Translational Medicine Clinical Research and Infrastructure Trials Platform, with support from Advantage West Midlands (AWM). The trial sponsor is the University of Warwick and University Hospitals Coventry and Warwickshire NHS Trust. SL and EW are supported by funding from the National Institute for Health Research (NIHR) Collaboration for Leadership in Applied Health Research and Care Oxford at Oxford Health NHS Foundation Trust, and the NIHR Biomedical Research Unit, Oxford.
Disclaimer The views expressed are those of the author(s) and not necessarily those of the NHS, the NIHR or the Department of Health.
Competing interests CL provides private physiotherapy to patients with cancer.
Patient consent Obtained.
Ethics approval Ethical approval was granted from the NHS National Research Ethics Service (NRES) Committee West Midlands (Solihull) (15/WM/0224) on 20 July 2015. Site-specific approvals have been obtained from NHS Research, Development and Innovation departments.
Provenance and peer review Not commissioned; externally peer reviewed.
Collaborators PROSPER Study Group: chief investigator: Professor Julie Bruce. Co-investigators (Grant holders): Professor Sarah E Lamb, Dr Esther Williamson, Dr Ranjit Lall, Professor Stavros Petrou, Mr Alastair M Thompson, Dr John Williams and Dr Catherine Harkin (deceased). Trial co-ordination/administration: Mrs Emma J Withers, Mrs Lauren Betteley, Mr Craig Turner, Mrs Loraine Chowdhury. Senior Project Managers: Mrs Susie Hennings, Mrs Helen Higgins. Research Fellows/Associates: Dr Helen Richmond, Mrs Clare Lait (Physiotherapist), Dr Sophie Rees (Qualitative), Mr Bruno Mazuquin (Research Physiotherapist), Mr Pankaj Mistry (Medical Statistics), Dr Alastair Canaway (Health Economics). Patient representatives: Dr Catherine Harkin (deceased), Mrs Marie van Laar, Mrs Lyn Ankcorn. Surgical leads: Miss Abigail Tomlins, Miss Raghavan Vidya, Ms Pankaj G Roy, Miss Kat McEvoy, Miss Rachel Soulsby. Intervention development: Mrs Clare Lait, Dr Esther Williamson, Dr Cynthia Srikesavan, Mrs Jane Moser, Dr Meredith Newman, Dr Sophie Rees, Mrs Lauren Betteley, Dr Helen Richmond, Dr Beth Fordham, Professor Sarah E Lamb and Professor Julie Bruce. Data programming team: Mr Ade Willis, Mr Henry Adjei. Quality assurance: Ms Claire Daffern.
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