Randomised controlled trial of exercise to prevent shoulder problems in women undergoing breast cancer treatment: study protocol for the prevention of shoulder problems trial (UK PROSPER).

Musculoskeletal shoulder problems are common after breast cancer treatment. Early postoperative exercises targeting the upper limb may improve shoulder function. This protocol describes a National Institute for Health Research-funded randomised controlled trial (RCT) to evaluate the clinical and cost-effectiveness of an early supervised structured exercise programme compared with usual care, for women at high risk of developing shoulder problems after breast cancer surgery. This pragmatic two-armed, multicentre RCT is underway within secondary care in the UK. PRevention Of Shoulder ProblEms tRial (PROSPER) aims to recruit 350 women from approximately 15 UK centres with follow-up at 6 weeks, 6 and 12 months after randomisation. Recruitment processes and intervention development were optimised through qualitative research during a 6-month internal pilot phase. Participants are randomised to the PROSPER intervention or best practice usual care only. The PROSPER intervention is delivered by physiotherapists and 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 primary outcome is upper arm function assessed using the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire at 12 months postrandomisation. Secondary outcomes include DASH subscales, acute and chronic pain, complications, health-related quality of life and healthcare resource use. We will interview a subsample of 20 participants to explore their experiences of the trial interventions. The PROSPER study is the first multicentre UK clinical trial to investigate the clinical and cost-effectiveness of supported exercise in the prevention of shoulder problems in high-risk women undergoing breast cancer surgery. The findings will inform future clinical practice and provide valuable insight into the role of physiotherapy-supported exercise in breast cancer rehabilitation. Version 2.1; dated 11 January 2017 TRIAL REGISTRATION NUMBER: ISRCTN35358984; Pre-results.

Bruce J ，Williamson E ，Lait C ，Richmond H ，Betteley L ，Lall R ，Petrou S ，Rees S ，Withers EJ ，Lamb SE ，Thompson AM ，PROSPER Study Group ... -  《BMJ Open》

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

Richmond H ，Lait C ，Srikesavan C ，Williamson E ，Moser J ，Newman M ，Betteley L ，Fordham B ，Rees S ，Lamb SE ，Bruce J ，PROSPER Study Group ... -  《BMC HEALTH SERVICES RESEARCH》

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

Bruce J ，Mazuquin B ，Mistry P ，Rees S ，Canaway A ，Hossain A ，Williamson E ，Padfield EJ ，Lall R ，Richmond H ，Chowdhury L ，Lait C ，Petrou S ，Booth K ，Lamb SE ，Vidya R ，Thompson AM ... -  《-》

Exercise versus usual care after non-reconstructive breast cancer surgery (UK PROSPER): multicentre randomised controlled trial and economic evaluation.

To evaluate whether a structured exercise programme improved functional and health related quality of life outcomes compared with usual care for women at high risk of upper limb disability after breast cancer surgery. Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation. 17 UK National Health Service cancer centres. 392 women undergoing breast cancer surgery, at risk of postoperative upper limb morbidity, randomised (1:1) to usual care with structured exercise (n=196) or usual care alone (n=196). Usual care (information leaflets) only or usual care plus a physiotherapy led exercise programme, incorporating stretching, strengthening, physical activity, and behavioural change techniques to support adherence to exercise, introduced at 7-10 days postoperatively, with two further appointments at one and three months. Disability of Arm, Hand and Shoulder (DASH) questionnaire at 12 months, analysed by intention to treat. Secondary outcomes included DASH subscales, pain, complications, health related quality of life, and resource use, from a health and personal social services perspective. Between 26 January 2016 and 31 July 2017, 951 patients were screened and 392 (mean age 58.1 years) were randomly allocated, with 382 (97%) eligible for intention to treat analysis. 181 (95%) of 191 participants allocated to exercise attended at least one appointment. Upper limb function improved after exercise compared with usual care (mean DASH 16.3 (SD 17.6) for exercise (n=132); 23.7 (22.9) usual care (n=138); adjusted mean difference 7.81, 95% confidence interval 3.17 to 12.44; P=0.001). Secondary outcomes favoured exercise over usual care, with lower pain intensity at 12 months (adjusted mean difference on numerical rating scale -0.68, -1.23 to -0.12; P=0.02) and fewer arm disability symptoms at 12 months (adjusted mean difference on Functional Assessment of Cancer Therapy-Breast+4 (FACT-B+4) -2.02, -3.11 to -0.93; P=0.001). No increase in complications, lymphoedema, or adverse events was noted in participants allocated to exercise. Exercise accrued lower costs per patient (on average -£387 (€457; $533) (95% confidence interval -£2491 to £1718; 2015 pricing) and was cost effective compared with usual care. The PROSPER exercise programme was clinically effective and cost effective and reduced upper limb disability one year after breast cancer treatment in patients at risk of treatment related postoperative complications. ISRCTN Registry ISRCTN35358984.

Bruce J ，Mazuquin B ，Canaway A ，Hossain A ，Williamson E ，Mistry P ，Lall R ，Petrou S ，Lamb SE ，Rees S ，Padfield E ，Vidya R ，Thompson AM ，Prevention of Shoulder Problems Trial (PROSPER) Study Group ... -  《BMJ-British Medical Journal》

Role of physiotherapy in supporting recovery from breast cancer treatment: a qualitative study embedded within the UK PROSPER trial.

To explore the experiences of women with breast cancer taking part in an early physiotherapy-led exercise intervention compared with the experiences of those receiving usual care. To understand physiotherapists' experience of delivering the trial intervention. To explore acceptability of the intervention and issues related to the implementation of the Prevention Of Shoulder Problems (PROSPER) programme from participant and physiotherapist perspective. Qualitative semistructured interviews with thematic analysis. UK National Health Service. Twenty participants at high risk of shoulder problems after breast cancer surgery recruited to the UK PROSPER trial (10 each from the intervention arm and control arm), and 11 physiotherapists who delivered the intervention. Trial participants were sampled using convenience sampling. Physiotherapists were purposively sampled from high and low recruiting sites. Participants described that the PROSPER exercise intervention helped them feel confident in what their body could do and helped them regain a sense of control in the context of cancer treatment, which was largely disempowering. Control arm participants expressed less of a sense of control over their well-being. Physiotherapists found the exercise intervention enjoyable to deliver and felt it was valuable to their patients. The extra time allocated for appointments during intervention delivery made physiotherapists feel they were providing optimal care, being the 'perfect physio'. Lessons were learnt about the implementation of a complex exercise intervention for women with breast cancer, and the issues raised will inform the development of a future implementation strategy. A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies helped women at risk of shoulder problems following breast cancer treatment to feel more confident in their ability to mobilise their arm post-surgery. A physiotherapist-delivered early supported exercise intervention with integrated behavioural strategies may address the sense of powerlessness that many women experience during breast cancer treatment.Trial registration number ISRCTN35358984.

Rees S ，Mazuquin B ，Richmond H ，Williamson E ，Bruce J ，UK PROSPER Study Group ... -  《BMJ Open》