Abstract
BackgroundMusculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER).MethodsA pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres.DiscussionThe PROSPER intervention 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 final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions.Trial registrationInternational Standard Randomised Controlled Trial Number: ISRCTN 35358984.
Highlights
Musculoskeletal shoulder problems are common after breast cancer treatment
There is some evidence that postoperative exercise may improve shoulder function in women at higher risk of shoulder problems after breast cancer surgery; uncertainty remains over the optimal content, timing and cost-effectiveness of exercise interventions [2]
Previous trials investigating the effectiveness and safety of postoperative exercise have methodological weaknesses including small sample sizes, limited duration of participant follow-up, lack of inclusion of important functional outcomes and failure to describe trial interventions adequately [2]. This weak evidence base resulted in the National Institute for Health Research (NIHR) commissioning the UK PROSPER trial (PRevention Of Shoulder ProblEms tRial); a randomised controlled trial (RCT) evaluating the clinical and cost effectiveness of early exercise in women with newly diagnosed breast cancer
Summary
Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. Previous trials investigating the effectiveness and safety of postoperative exercise have methodological weaknesses including small sample sizes, limited duration of participant follow-up, lack of inclusion of important functional outcomes and failure to describe trial interventions adequately [2]. This weak evidence base resulted in the National Institute for Health Research (NIHR) commissioning the UK PROSPER trial (PRevention Of Shoulder ProblEms tRial); a randomised controlled trial (RCT) evaluating the clinical and cost effectiveness of early exercise in women with newly diagnosed breast cancer. As per Medical Research Council (MRC) guidance for the development and evaluation of complex intervention trials and recent calls for improved reporting of trial interventions, we followed the Template for Intervention Development and Replication (TIDieR), and considered the recently published Consensus on Exercise Reporting Template (CERT) for comprehensive reporting of exercise interventions [4,5,6]
Sign-in/Register to view highlights & summary Sign-in/Register to access full text options 
Talk to us
Join us for a 30 min session where you can share your feedback and ask us any queries you have
Schedule a call
