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Randomized Controlled Trial
. 2024 Jul 5;24(1):802.
doi: 10.1186/s12885-024-12464-7.

Participants' perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study

Amelia Talbot  1 , Susan A Jebb  1 , Claire Foster  2 , Alba X Realpe  3 , Pete Wheatstone  4 , Simon Buczacki  5 , Dimitrios A Koutoukidis  6
Affiliations
Randomized Controlled Trial

Participants' perspectives of being recruited into a randomised trial of a weight loss intervention before colorectal cancer surgery: a qualitative interview study

Amelia Talbot et al. BMC Cancer. .

Abstract

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.

Keywords: Colorectal Cancer; Interviews; Obesity; Qualitative evaluation; Qualitative research; Weight loss.

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Conflict of interest statement

DAK and SAJ report being investigators in two publicly-funded (NIHR) trials where Nestle Health Science and Oviva donated the weight loss intervention to the University of Oxford outside the submitted work. No other authors declare competing interest.

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