Sremanakova Jana, Sowerbutts Anne Marie, Todd Chris, Cooke Richard, Pearce Lyndsay, Leiberman David, McLaughlin John, Hill Jim, Ashby Helen, Ramesh Aswatha, Burden Sorrel
School of Health Sciences, University of Manchester, Oxford Road, Manchester, M13 9PL, UK.
Manchester Academic Health Science Centre, Manchester, M13 9PL, UK.
Eur J Clin Nutr. 2024 Dec;78(12):1095-1104. doi: 10.1038/s41430-024-01491-z. Epub 2024 Aug 27.
Evidence from cohort studies indicates that a healthy lifestyle can improve cancer survival but evidence from randomised controlled trials (RCT) is lacking. Thus, this study tested the feasibility of conducting a lifestyle intervention in patients after colorectal cancer (CRC) treatment.
An intervention was developed based on World Cancer Research Fund and American Institute for Cancer Research (WCRF/AICR) recommendations, the Health Action Process Approach, Motivational Interviewing and tested a feasibility, mixed-methods RCT. Participants were allocated to a three-month telephone-based intervention versus standard care control group. The follow up period was six months. Data on feasibility and secondary outcomes were collected and analysed using Stata (V15, StataCorp LLC) and NVivo 12 (QSR International Pty Ltd., Doncaster, VIC).
Recruitment was challenging (31 ineligible, 37 declined; recruitment rate = 48.6%.). In total, 34/35 participants completed the intervention, and 31 (89%) completed follow up; all 31 completers participated in six telephone calls during intervention and six months follow up. Study retention was 97% (34/35) and 89% (31/35) at three and six months, respectively. Data completion rates were high (>90%). Intervention was acceptable to participants, met their needs and kept them accountable towards their goals. Participants in the intervention group showed significant improvement in WCRF/AICR, Diet Quality Index-International score and a 10% reduction in ultra-processed food consumption.
The HEAL ABC intervention was feasible for 87% of intervention participants, supporting them in healthy lifestyle changes. However, alternative recruitment strategies are needed for a fully powered RCT to determine the effectiveness of the intervention.
队列研究的证据表明,健康的生活方式可以提高癌症生存率,但缺乏随机对照试验(RCT)的证据。因此,本研究测试了对结直肠癌(CRC)治疗后的患者进行生活方式干预的可行性。
基于世界癌症研究基金会和美国癌症研究学会(WCRF/AICR)的建议、健康行动过程方法、动机性访谈开发了一种干预措施,并测试了一项可行性混合方法RCT。参与者被分配到为期三个月的电话干预组或标准护理对照组。随访期为六个月。使用Stata(V15,StataCorp有限责任公司)和NVivo 12(QSR国际私人有限公司,维多利亚州唐卡斯特)收集和分析关于可行性和次要结果的数据。
招募具有挑战性(31人不符合条件,37人拒绝;招募率=48.6%)。总共有34/35名参与者完成了干预,31人(89%)完成了随访;所有31名完成者在干预期间和六个月随访期间都参加了六次电话会议。研究保留率在三个月和六个月时分别为97%(34/35)和89%(31/35)。数据完成率很高(>90%)。干预措施为参与者所接受,满足了他们的需求,并使他们对自己的目标负责。干预组的参与者在WCRF/AICR、国际饮食质量指数得分方面有显著改善,超加工食品消费量减少了10%。
HEAL ABC干预对87%的干预参与者是可行的,支持他们进行健康的生活方式改变。然而,需要采用替代招募策略进行一项有充分效力的RCT,以确定该干预措施的有效性。