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.

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.