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

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

BMJ 2021; 375 doi: https://doi.org/10.1136/bmj-2021-066542 (Published 11 November 2021) Cite this as: BMJ 2021;375:e066542
  1. Julie Bruce, professor of clinical trials1,
  2. Bruno Mazuquin, research fellow2,
  3. Alastair Canaway, health economist1,
  4. Anower Hossain, statistician3,
  5. Esther Williamson, ARC senior research fellow4,
  6. Pankaj Mistry, statistician1,
  7. Ranjit Lall, professor of clinical trials1,
  8. Stavros Petrou, professor of health economics5,
  9. Sarah E Lamb, associate dean for research6,
  10. Sophie Rees, senior research fellow1,
  11. Emma Padfield, senior project manager1,
  12. Raghavan Vidya, consultant oncoplastic breast surgeon7,
  13. Alastair M Thompson, professor of surgery8
  14. on behalf of the Prevention of Shoulder Problems Trial (PROSPER) Study Group
    1. 1Warwick Clinical Trials Unit, Division of Health Sciences, University of Warwick, Coventry, UK
    2. 2Faculty of Health, Psychology and Social Care, Manchester Metropolitan University, Manchester, UK
    3. 3Institute of Statistical Research and Training (ISRT), University of Dhaka, Dhaka, Bangladesh
    4. 4Nuffield Department of Orthopaedics Rheumatology and Musculoskeletal Sciences, University of Oxford, Oxford, UK
    5. 5Nuffield Department of Primary Care Health Sciences, University of Oxford, Oxford, UK
    6. 6Institute of Health Research, University of Exeter, Exeter, UK
    7. 7Royal Wolverhampton NHS Trust, Wolverhampton, UK
    8. 8Department of Surgery, Dan L Duncan Comprehensive Cancer Center, Baylor College of Medicine, Houston, TX 77030, USA
    1. Correspondence to: J Bruce julie.bruce{at}warwick.ac.uk (or @jxbruce on Twitter)
    • Accepted 22 October 2021

    Abstract

    Objective 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.

    Design Multicentre, pragmatic, superiority, randomised controlled trial with economic evaluation.

    Setting 17 UK National Health Service cancer centres.

    Participants 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).

    Interventions 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.

    Main outcome measures 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.

    Results 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.

    Conclusions 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.

    Trial registration ISRCTN Registry ISRCTN35358984.

    Footnotes

    • Contributors: JB, EW, SL, RL, AMT, and SP were responsible for securing funding, design of the trial and intervention, and oversight of study management. RL oversaw statistical analysis undertaken by PM and AH. AC and SP were responsible for health economic analysis. BM and JB oversaw delivery of the intervention. SR coordinated patient representation and qualitative research. EP coordinated trial management. All authors were responsible for interpretation of data and for approving the draft manuscript. JB is the guarantor. The corresponding author attests that all listed authors meet authorship criteria and that no others meeting the criteria have been omitted.

    • Funding: UK National Institute for Health Research (NIHR) Health Technology Assessment Programme project 13/84/10. JB acknowledges support from NIHR Research Capability Funding via University Hospitals Coventry and Warwickshire NHS Trust. EW is supported by the National Institute for Health Research Applied Research Collaboration Oxford and Thames Valley at Oxford Health NHS Foundation Trust. SP receives support as a NIHR senior investigator (NF-SI-0616-10103) and from the NIHR Applied Research Collaboration Oxford and Thames Valley. The funders had no role in considering the study design or in the collection, analysis, interpretation of data, writing of the report, or decision to submit the article for publication. The corresponding author had full access to study data and had final responsibility to submit for publication.

    • Competing interests: All authors have completed the ICMJE uniform disclosure form at www.icmje.org/disclosure-of-interest/ and declare: support from the UK National Institute for Health Research (NIHR) Technology Assessment Programme; JB received grants from the UK NIHR during the conduct of this study and is a member of the NIHR Research for Patient Benefit board; SL reports membership of the UK NIHR Health Technology Assessment (HTA) Additional Capacity Funding Board, HTA End of Life Care and Add-on Studies Board, HTA Prioritisation Group Board, and HTA Trauma Board; no other relationships or activities that could appear to have influenced the submitted work.

    • The lead author affirms that the manuscript is an honest, accurate, and transparent account of the study being reported; that no important aspects of the study have been omitted; and that any discrepancies from the study as planned (and, if relevant, registered) have been explained.

    • Dissemination to participants and related patient and public communities: We had invited trial participants to a dissemination event in March 2020, but this was cancelled owing to covid-19. We will publish a plain language summary of study results on the University of Warwick Clinical Trials Unit website for trial participants and distribute it to cancer units and physiotherapy departments involved in the research.

    • Provenance and peer review: Not commissioned; externally peer reviewed.

    Data availability statement

    All data requests should be submitted to the corresponding author for consideration. Access to anonymised data may be granted following review. Data will be shared, with investigator support, after approval of a proposal, with a signed data access agreement. The study protocol and intervention materials are available online.

    http://creativecommons.org/licenses/by/4.0/

    This is an Open Access article distributed in accordance with the terms of the Creative Commons Attribution (CC BY 4.0) license, which permits others to distribute, remix, adapt and build upon this work, for commercial use, provided the original work is properly cited. See: http://creativecommons.org/licenses/by/4.0/.

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