A physiotherapy-led exercise programme starting within weeks of breast cancer surgery could prevent long-term shoulder problems in women at high risk. Shoulder pain and stiffness are common after breast cancer treatment, especially for women who have lymph node removal, radiotherapy, or limited movement before surgery. Current NHS practice typically offers only an information leaflet with unsupervised exercises. The PROSPER trial tests whether three to six supervised sessions with a specialist physiotherapist, combined with behavioural strategies to encourage adherence, produce better outcomes than this usual care. If the programme proves effective and cost-effective, it could change how the NHS manages post-surgical rehabilitation for breast cancer patients. Rather than leaving women to manage exercises alone, hospitals could offer a structured, monitored pathway that reduces chronic pain, improves arm and shoulder function, and cuts the need for additional treatment. The trial involves 350 women across 10 UK breast cancer centres, with outcomes measured at 12 months using the DASH questionnaire for arm, shoulder and hand function, alongside economic analysis to determine whether the NHS should adopt the intervention widely.
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Hypothesis: An early supervised exercise programme delivered to women after breast cancer surgery can improve outcomes of shoulder function, health-related quality of life and reduce chronic pain and related adverse events at 12 months after treatment. The aim of PROSPER is to investigate early supervised exercise compared to usual care within a randomised controlled trial (RCT), supported by qualitative methods and economic evaluation, to determine whether this is a feasible and cost-effectiveness intervention for the NHS. Design: Pragmatic multicentre RCT with economic evaluation. An internal pilot study incorporating qualitative research will be conducted in two centres the first year. Setting: 10 UK Breast cancer centres Target population: Women requiring surgery for primary breast cancer who are at high risk of developing shoulder problems, including those undergoing: breast surgery with axillary clearance or extensive axillary sampling; postoperative radiotherapy (RT); those with limited range of shoulder movement preoperatively; and obesity. Reconstruction patients will be excluded. Intervention: A physiotherapy-led supervised exercise programme with an agreed monitoring plan incorporating behavioural strategies to encourage adherence will be initiated after surgery. Participants will be offered 3 face-to-face specialist physiotherapy sessions delivered up to 16 weeks after surgery. Additional physiotherapy (+3 sessions) will be provided if needed up to 12 months after surgery. The programme will include controlled early range of movement exercises with subsequent progression to restore strength and function and then a maintenance programme. Comparison: usual care is unsupervised exercise using an information leaflet based upon current best practice. Outcomes: Primary outcome is arm, shoulder and hand function at 12 months, using the DASH questionnaire. Secondary outcomes include instruments to capture treatment side effects (pain, surgical site infection) and health-related quality of life. Healthcare resource use will be collected at 6 and 12 months after surgery. Sample size: 350 women, 175 per treatment arm. The study is powered to allow the detection of an effect size of 0.35 with 80% power, 5% 2-sided significance level and allowing for 25% attrition rate. This effect size is equivalent to a difference in the DASH score of 7 points at 12 months between the two groups based on a standard deviation of 19.65. Project timeline: Year 1) Develop, revise and test the intervention package and launch an internal pilot study in 2 breast cancer centres (Coventry and Oxford). Qualitative interviews will explore the acceptability of the intervention, timing and procedures for approching patient for recruitment and consent. Procedures for screening of risk status will be developed and tested in the pilot study. Year 2). Launch and conduct main trial in 8 other breast cancer centres, giving a total of 10 centres opened by mid-2016. Target recruitment 2 participants per centre. Deliver intervention and conduct monitoring. Year 3) Participant recruitment and postoperative follow-up. Year 4) Complete follow-up, enter, clean and analyse clinical and economic data. Write publications and dissemination.
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