Exercise to prevent shoulder problems after breast cancer surgery: the PROSPER RCT

• Published in: Health technology assessment (Winchester, England) England), 2022-02, Vol.26 (15), p.1-124
• Main Authors: Bruce, Julie, Mazuquin, Bruno, Mistry, Pankaj, Rees, Sophie, Canaway, Alastair, Hossain, Anower, Williamson, Esther, Padfield, Emma J, Lall, Ranjit, Richmond, Helen, Chowdhury, Loraine, Lait, Clare, Petrou, Stavros, Booth, Katie, Lamb, Sarah E, Vidya, Raghavan, Thompson, Alastair M
• Format: Article
• Language: English
• Subjects: Adult; Aged; Aged, 80 and over; breast cancer; Breast Neoplasms - surgery; Cost-Benefit Analysis; economic evaluation; Exercise; Female; Humans; Lymphedema; Middle Aged; Pain; physiotherapy; Quality of Life; randomised controlled trial; Shoulder; Upper Extremity
• ISSN: 1366-5278; 2046-4924
• DOI: 10.3310/JKNZ2003

Upper limb problems are common after breast cancer treatment. To investigate the clinical effectiveness and cost-effectiveness of a structured exercise programme compared with usual care on upper limb function, health-related outcomes and costs in women undergoing breast cancer surgery. This was a two-arm, pragmatic, randomised controlled trial with embedded qualitative research, process evaluation and parallel economic analysis; the unit of randomisation was the individual (allocated ratio 1 : 1). Breast cancer centres, secondary care. Women aged ≥ 18 years who had been diagnosed with breast cancer and were at higher risk of developing shoulder problems. Women were screened to identify their risk status. All participants received usual-care information leaflets. Those randomised to exercise were referred to physiotherapy for an early, structured exercise programme (three to six face-to-face appointments that included strengthening, physical activity and behavioural change strategies). The primary outcome was upper limb function at 12 months as assessed using the Disabilities of Arm, Hand and Shoulder questionnaire. Secondary outcomes were function (Disabilities of Arm, Hand and Shoulder questionnaire subscales), pain, complications (e.g. wound-related complications, lymphoedema), health-related quality of life (e.g. EuroQol-5 Dimensions, five-level version; Short Form questionnaire-12 items), physical activity and health service resource use. The economic evaluation was expressed in terms of incremental cost per quality-adjusted life-year and incremental net monetary benefit gained from an NHS and Personal Social Services perspective. Participants and physiotherapists were not blinded to group assignment, but data collectors were blinded. Between 2016 and 2017, we randomised 392 participants from 17 breast cancer centres across England: 196 (50%) to the usual-care group and 196 (50%) to the exercise group. Ten participants (10/392; 3%) were withdrawn at randomisation and 32 (8%) did not provide complete baseline data. A total of 175 participants (89%) from each treatment group provided baseline data. Participants' mean age was 58.1 years (standard deviation 12.1 years; range 28-88 years). Most participants had undergone axillary node clearance surgery (327/392; 83%) and 317 (81%) had received radiotherapy. Uptake of the exercise treatment was high, with 181 out of 196 (92%) participants attending at least one physiotherapy appointment. Compliance with exe