参与结直肠癌手术前减肥干预随机试验招募的参与者观点：定性访谈研究。

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

机构信息

Nuffield Department of Primary Health Care Sciences, University of Oxford, Radcliffe Primary Care Building, Radcliffe Observatory Quarter, Woodstock Road, Oxford, OX2 6GG, UK.

Centre for Psychosocial Research in Cancer, Faculty of Health Sciences, University of Southampton, Southampton, SO17 1BJ, UK.

出版信息

BMC Cancer. 2024 Jul 5;24(1):802. doi: 10.1186/s12885-024-12464-7.

DOI:10.1186/s12885-024-12464-7

PMID:38969979

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11225294/

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/m (± 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.

摘要

背景

癌症诊断与手术之间的这段时间为评估行为改变干预措施可行性的试验提供了机会。然而，对于患者来说，这可能是一个令人担忧的时期，并且可能会阻碍招募。我们描述了等待结直肠癌手术的超重患者对其入组一项减肥预康复干预的随机试验的看法。

方法

我们在英格兰 8 个招募地点的“CARE”可行性试验中对前 26 名参与者进行了采访。参与者被随机分配到常规护理组（n=13）或低能量营养充足的全饮食替代计划组，由营养师每周提供远程行为支持（n=13）。半结构化访谈在招募后不久进行，问题集中在参与者对入组试验的回忆上。我们快速分析数据，然后使用思维导图技术开发描述性主题。所有合著者，包括一位有结直肠癌手术经历的人，都同意主题。

结果

参与者的平均体重指数（±标准差）为 38kg/m（±6），年龄为 50 岁（±12），42%为女性。参与试验的人是因为提供了有组织的减肥支持而受到激励，这可能有助于他们改善手术结果。然而，参与者也对干预饮食的潜在不可口和副作用表示担忧。临床医生对试验的积极态度促进了招募，但当他们因临床团队过于强调减肥的好处而被随机分配到常规护理组时，参与者感到失望。