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Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment : the prevention of shoulder problems trial (UK PROSPER)
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PROSPER Study Group (Including: Richmond, Helen, Lait, Clare, Srikesavan, Cynthia, Williamson, Esther, Moser, Jane, Newman, Meredith, Betteley, Lauren, Fordham, Beth, Rees, Sophie, Lamb, S. E. (Sallie E.) and Bruce, J. (Julie)). (2018) Development of an exercise intervention for the prevention of musculoskeletal shoulder problems after breast cancer treatment : the prevention of shoulder problems trial (UK PROSPER). BMC Health Services Research, 18 (1). 463. doi:10.1186/s12913-018-3280-x ISSN 1472-6963.
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Official URL: http://dx.doi.org/10.1186/s12913-018-3280-x
Abstract
Background
Musculoskeletal shoulder problems are common after breast cancer treatment. There is some evidence to suggest that early postoperative exercise is safe and may improve shoulder function. We describe the development and delivery of a complex intervention for evaluation within a randomised controlled trial (RCT), designed to target prevention of musculoskeletal shoulder problems after breast cancer surgery (The Prevention of Shoulder Problems Trial; PROSPER).
Methods
A pragmatic, multicentre RCT to compare the clinical and cost-effectiveness of best practice usual care versus a physiotherapy-led exercise and behavioural support intervention in women at high risk of shoulder problems after breast cancer treatment. PROSPER will recruit 350 women from approximately 15 UK centres, with follow-up at 6 and 12 months. The primary outcome is shoulder function at 12 months; secondary outcomes include postoperative pain, health related quality of life, adverse events and healthcare resource use. A multi-phased approach was used to develop the PROSPER intervention which was underpinned by existing evidence and modified for implementation after input from clinical experts and women with breast cancer. The intervention was tested and refined further after qualitative interviews with patients newly diagnosed with breast cancer; a pilot RCT was then conducted at three UK clinical centres.
Discussion
The PROSPER intervention 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 final PROSPER intervention is fully manualised with clear, documented pathways for clinical assessment, exercise prescription, use of behavioural strategies, and with guidance for treatment of postoperative complications. This paper adheres to TIDieR and CERT recommendations for the transparent, comprehensive and explicit reporting of complex interventions.
Trial registration: International Standard Randomised Controlled Trial Number: ISRCTN 35358984.
| Item Type: | Journal Article | ||||||
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| Subjects: | R Medicine > RC Internal medicine > RC0254 Neoplasms. Tumors. Oncology (including Cancer) R Medicine > RD Surgery |
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| Divisions: | Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Clinical Trials Unit Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School > Health Sciences Faculty of Science, Engineering and Medicine > Medicine > Warwick Medical School |
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| Library of Congress Subject Headings (LCSH): | Breast -- Cancer -- Surgery -- Complications, Shoulder -- Diseases | ||||||
| Journal or Publication Title: | BMC Health Services Research | ||||||
| Publisher: | Biomed Central Ltd | ||||||
| ISSN: | 1472-6963 | ||||||
| Official Date: | 18 June 2018 | ||||||
| Dates: |
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| Volume: | 18 | ||||||
| Number: | 1 | ||||||
| Article Number: | 463 | ||||||
| DOI: | 10.1186/s12913-018-3280-x | ||||||
| Status: | Peer Reviewed | ||||||
| Publication Status: | Published | ||||||
| Access rights to Published version: | Open Access (Creative Commons) | ||||||
| Copyright Holders: | The Authors | ||||||
| Date of first compliant deposit: | 20 July 2018 | ||||||
| Date of first compliant Open Access: | 1 August 2018 | ||||||
| RIOXX Funder/Project Grant: |
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