Journal Article

Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment: the prevention of shoulder problems trial (UK PROSPER)

Rees, Sophie, Fordham, Beth, Lait, Clare, Moser, Jane, Williamson, Esther, Betteley, Lauren, Lamb, Sarah E., Bruce, Julie, Srikesavan, Cynthia, Richmond, Helen, Newman, Meredith

2018

Overview

Background 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. 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). Methods A 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. Discussion The 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 registration International Standard Randomised Controlled Trial Number: ISRCTN 35358984 .

• Publisher: BioMed Central,BioMed Central Ltd,Springer Nature B.V,BMC
• Subject: Behavior Therapy / Behavioural support strategies / Biomarkers / Breast cancer / Breast Neoplasms - epidemiology / Breast Neoplasms - surgery / Cancer surgery / Cancer therapies / Care and treatment / Chemotherapy / Clinical trials / Connective tissue / Cost analysis / Cost-Benefit Analysis / Diagnosis / Exercise / Exercise Therapy - methods / Female / Fitness training programs / Health Administration / Health aspects / Health Informatics / Health services / Humans / Intervention / Lymphedema / Mastectomy - rehabilitation / Medicine / Medicine & Public Health / Mortality / Musculoskeletal diseases / Musculoskeletal Diseases - prevention & control / Nursing Research / Organization / Pain / Patient Compliance / Patient Outcome Assessment / Patients / Physical activity / Physical fitness / Physical therapy / Physiology / Pilot Projects / Postoperative Complications - prevention & control / Prevention / Public Health / Quality of Life / Radiation therapy / Shoulder / Shoulder - physiopathology / Shoulder dysfunction / Shoulder exercises / structure and delivery of healthcare / Study Protocol / Systematic review / United Kingdom - epidemiology / Upper limb / Womens health