Journal article
Participants’ perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study
- Abstract:
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Background
The period between cancer diagnosis and surgery presents an opportunity for trials to assess the feasibility of behaviour change interventions. However, this can be a worrying time for patients and may hinder recruitment. We describe the perspectives of patients with excess weight awaiting colorectal cancer surgery about their recruitment into a randomised trial of a prehabilitation weight loss intervention.Methods
We interviewed the first 26 participants from the 8 recruitment sites across England in the ‘CARE’ feasibility trial. Participants were randomised into either usual care (n=13) or a low-energy nutritionally-replete total diet replacement programme with weekly remote behavioural support by a dietitian (n=13). The semi-structured interviews occurred shortly after recruitment and the questions focused on participants’ recollections of being recruited into the trial. We analysed data rapidly and then used a mind-mapping technique to develop descriptive themes. Themes were agreed by all co-authors, including a person with lived-experience of colorectal surgery.Results
Participants had a mean body mass index (± SD) of 38 kg/m2 (± 6), age of 50 years (± 12), and 42% were female. People who participated in the trial were motivated by the offer of structured weight loss support that could potentially help them improve their surgical outcomes. However, participants also had concerns around the potential unpalatability of the intervention diet and side effects. Positive attitudes of clinicians towards the trial facilitated recruitment but participants were disappointed when they were randomised to usual care due to clinical teams’ overemphasis on the benefits of losing weight.Conclusions
Patients were motivated to take part by the prospect of improved surgical outcomes. However, the strong preference to be allocated to the intervention suggests that balanced communication of equipoise is crucial to minimise disappointment from randomisation to usual care and differential dropout from the trial.Clinical Trial Registration
ISRCTN39207707, Registration date 13/03/2023
- Publication status:
- Published
- Peer review status:
- Peer reviewed
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(Preview, Version of record, pdf, 1.0MB, Terms of use)
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- Publisher copy:
- 10.1186/s12885-024-12464-7
Authors
- Publisher:
- BioMed Central
- Journal:
- BMC Cancer More from this journal
- Volume:
- 24
- Issue:
- 1
- Article number:
- 802
- Publication date:
- 2024-07-05
- Acceptance date:
- 2024-06-03
- DOI:
- EISSN:
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1471-2407
- Language:
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English
- Keywords:
- Pubs id:
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2003587
- Local pid:
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pubs:2003587
- Deposit date:
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2024-06-03
Terms of use
- Copyright holder:
- Talbot et al
- Copyright date:
- 2024
- Rights statement:
- © The Author(s) 2024 This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made. The images or other third party material in this article are included in the article’s Creative Commons licence, unless indicated otherwise in a credit line to the material. If material is not included in the article’s Creative Commons licence and your intended use is not permitted by statutory regulation or exceeds the permitted use, you will need to obtain permission directly from the copyright holder.
- Licence:
- CC Attribution (CC BY)
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