Title: Exercise to prevent shoulder conditions in patients undergoing breast cancer treatment. The PRevention Of Shoulder Problems Study (PROSPER)
Funder: Department of Health and Social Care

Abstract: 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.

Lay abstract: Breast cancer is the most common form of cancer in the UK. More women now survive, with 2 out of 3 women living for 20 years beyond their diagnosis. It is extremely important that the NHS cares for women to ensure recovery and return to usual activities after cancer treatment. Most women have surgery to the breast and axilla (armpit); some also have radiotherapy and chemotherapy. These treatments can affect the muscles, nerves and lymphatic vessels in the shoulder and upper body resulting in limited range of motion, weakness, persistent pain, altered sensations and lymphoedema (swelling due to accumulated lymphatic fluid). Studies suggest that between 10% and 64% of women have symptoms in their arm or shoulder up to 3 years after treatment. These persistent symptoms can limit daily activities, reduce quality of life and delay recovery. Research suggests that structured exercises programmes, commenced within days or weeks of surgery, can improve shoulder movement and reduce complications. These exercise programmes, if delivered to all, would be costly to the NHS. Usual NHS care is to provide information leaflets recommending upper body movements after breast cancer surgery to all women. Current NHS pressures mean that many cancer centres implement the "23-hour" care pathway, with the majority of women discharged hours or days after surgery without any physiotherapy support. Women who have extensive cancer treatment (e.g surgery to the axilla or radiotherapy) are at greater risk of developing shoulder problems. This study will compare 2 interventions for women at higher risk of upper body symptoms after cancer treatment: (a) usual care, which is a written information leaflet, compared to (b) a physiotherapy-led exercise programme with an individualised monitoring plan. The exercise programme will involve different phases: early controlled movements immediately after surgery (e.g. arm movement limited to shoulder height, 90° elevation); progression of exercises to restore full shoulder and arm range of motion; strengthening exercises to improve arm and shoulder strength and function and a maintenance phase to ensure motion and strength are retained (up to 12 months). A minimum of 3 face to face appointments with a physiotherapist will be offered within the first 16 weeks of surgery. Where possible, physiotherapy reviews will coincide with postoperative assessment clinics to prevent the need for additional hospital appointments. Milestones to monitor progress will be agreed at each physiotherapy review. Additional physiotherapy support will be available based on this monitoring plan - this may include support over the telephone. Strategies to help women to exercise regularly will be used in the active intervention, including exercise diaries, goal setting and problem solving to remove barriers to exercising. The research team have successfully used these behavioural methods in other clinical trials of exercise for musculoskeletal conditions. Patient interviews will explore acceptance of the exercise intervention. Patients will be asked to complete questionnaires at baseline, 6 and 12 months. We will compare differences in arm and shoulder function, quality of life, chronic pain and other symptoms at 1 year after breast cancer treatment. We will calculate costs for the development and delivery of the exercise intervention and compare to usual care.

Research activity codes: 6.7 PHYSICAL
Health categories: CANCER AND NEOPLASMS;MUSCULOSKELETAL