Eating As Treatment (EAT): A Stepped-Wedge, Randomized Controlled Trial of a Health Behavior Change Intervention Provided by Dietitians to Improve Nutrition in Patients With Head and Neck Cancer Undergoing Radiation Therapy (TROG 12.03)

Purpose: Malnutrition in head and neck cancer (HNC) treatment is common and associated with poorer morbidity and mortality outcomes. This trial aimed to improve nutritional status during radiation therapy (RT) using a novel method of training dietitians to deliver psychological techniques to improve nutritional behaviors in patients with HNC.

Methods and Materials: This trial used a stepped-wedge, randomized controlled design to assess the efficacy of the Eating As Treatment (EAT) program. Based on motivational interviewing and cognitive behavioral therapy, EAT was designed to be delivered by oncology dietitians and integrated into their clinical practice. During control steps, dietitians provided treatment as usual, before being trained in EAT and moving into the intervention phase. The training was principles based and sought to improve behavior-change skills rather than provide specific scripts. Patients recruited to the trial (151 controls, 156 intervention) were assessed at 4 time points (the first and the final weeks of RT, and 4 and 12 weeks afterward). The primary outcome was nutritional status at the end of RT as measured by the Patient-Generated Subjective Global Assessment.

Results: Patients who received the EAT intervention had significantly better scores on the primary outcome of nutritional status at the critical end-of-treatment time point (beta = -1.53 [-2.93 to -.13], P =.03). Intervention patients were also significantly more likely than control patients to be assessed as well-nourished at each time point, lose a smaller percentage of weight, have fewer treatment interruptions, present lower depression scores, and report a higher quality of life. Although results were not statistically significant, patients who received the intervention had fewer and shorter unplanned hospital admissions.

Conclusions: This trial is the first of its kind to demonstrate the effectiveness of a psychological intervention to improve nutrition in patients with HNC who are receiving RT. The intervention provides a means to ameliorate malnutrition and the important related outcomes and consequently should be incorporated into standard care for patients receiving RT for HNC. (C) 2018 Elsevier Inc. All rights reserved.