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作为治疗手段的进食行为干预(EAT)用于改善头颈部癌症患者营养状况的健康行为改变干预措施:一项阶梯式随机对照试验的 5 年死亡率结果。

Five-Year Mortality Outcomes for Eating As Treatment (EAT), a Health Behavior Change Intervention to Improve Nutrition in Patients With Head and Neck Cancer: A Stepped-Wedge, Randomized Controlled Trial.

机构信息

Hunter New England Health Mental Health, Hunter New England Local Health District, Newcastle, New South Wales, Australia; School of Medicine and Public Health, University of Newcastle, Callaghan, New South Wales, Australia.

National Drug and Alcohol Research Centre, University of New South Wales, Randwick, New South Wales, Australia.

出版信息

Int J Radiat Oncol Biol Phys. 2024 Jul 15;119(4):1166-1170. doi: 10.1016/j.ijrobp.2024.01.205. Epub 2024 Feb 5.

DOI:10.1016/j.ijrobp.2024.01.205
PMID:38320712
Abstract

PURPOSE

Malnutrition affects up to 80% of patients with head and neck cancer (HNC) and is associated with higher burden of disease, poorer treatment outcomes, and greater mortality. The Eating As Treatment (EAT) intervention is a behavioral intervention previously demonstrated to be effective in improving nutritional status, depression, and quality of life in patients with HNC. This article examines the effects of the EAT intervention on 5-year mortality among participants.

METHODS AND MATERIALS

A multicenter, stepped-wedge, randomized controlled trial was conducted in 5 Australian hospitals. Dietitians were trained to deliver EAT, a combination of motivational interviewing and cognitive behavior therapy strategies, to patients with HNC receiving radiation therapy. Secondary analyses of survival benefit on an intention-to-treat basis were performed. Differences in proportions of 5-year all-cause mortality between the control and EAT intervention arms were analyzed using multivariable logistic regression, and 5-year survival rates were analyzed using Cox proportional hazards regression. Analyses controlled for temporal effects (study duration), hospital site (clustering), and baseline nutritional status differences.

RESULTS

Overall, there were 64 deaths in the 5 years after enrollment, 36 (24%) among those assigned to the control condition and 28 (18%) among those assigned to EAT. Logistic regression showed statistically significant reduced odds in favor of EAT (odds ratio, 0.33; 95% CI, 0.11-0.96), with an absolute risk reduction of 17% (95% CI, 0.01-0.33) and a relative risk reduction of 55% (95% CI, 0.22-0.92), resulting in a number needed to treat of 6 (95% CI, 4-13). Survival analysis revealed that risk of death was significantly reduced by the EAT intervention (hazard ratio, 0.39; 0.16-0.96).

CONCLUSIONS

Participation in EAT provided a statistically and clinically meaningful survival benefit, likely via improved nutrition during radiation therapy. This survival benefit strengthens the finding of the main trial, showing that a behavioral intervention focused on nutrition could improve HNC outcomes. Replication studies using stepped-wedge designs for implementation into clinical practice may be warranted.

摘要

目的

营养不良影响多达 80%的头颈部癌症(HNC)患者,与疾病负担增加、治疗效果较差和死亡率较高有关。饮食即治疗(EAT)干预措施是一种行为干预措施,先前已证明该措施可有效改善 HNC 患者的营养状况、抑郁和生活质量。本文研究了 EAT 干预措施对参与者 5 年死亡率的影响。

方法和材料

在澳大利亚的 5 家医院进行了一项多中心、阶梯式、随机对照试验。营养师接受培训,为接受放射治疗的 HNC 患者提供 EAT,即动机访谈和认知行为治疗策略的结合。基于意向治疗进行了生存获益的二次分析。使用多变量逻辑回归分析控制时间效应(研究持续时间)、医院地点(聚类)和基线营养状况差异后,分析控制组和 EAT 干预组之间 5 年全因死亡率的差异。使用 Cox 比例风险回归分析 5 年生存率。

结果

总体而言,在入组后 5 年内有 64 例死亡,其中 36 例(24%)分配到对照组,28 例(18%)分配到 EAT 组。逻辑回归显示 EAT 显著降低了死亡风险(优势比,0.33;95%CI,0.11-0.96),绝对风险降低了 17%(95%CI,0.01-0.33),相对风险降低了 55%(95%CI,0.22-0.92),需要治疗的人数为 6 人(95%CI,4-13)。生存分析表明,EAT 干预显著降低了死亡风险(风险比,0.39;0.16-0.96)。

结论

参与 EAT 提供了具有统计学和临床意义的生存获益,可能是通过放射治疗期间改善营养实现的。这种生存获益加强了主要试验的发现,表明关注营养的行为干预措施可以改善 HNC 结局。可能需要使用阶梯式设计的复制研究来将其实施到临床实践中。

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