The impact of FIM interventions on anxiety, depression, and quality of life: Results from NutriCare randomized controlled trial.

Abstract

633 Background: Food is Medicine (FIM) programs, nutrition-focused clinical interventions, have been explored to improve overall health and quality of life among cancer patients. This study assessed patient-reported outcomes on anxiety, depression, and quality of life (QoL) from participants enrolled in NutriCare, a randomized clinical trial of medically tailored meals and nutrition counseling for patients with lung cancer. Methods: A total of 248 patients were randomized to the intervention arm NutriCare (n = 133) or the control arm NutriTool (n = 115). Anxiety and depression were assessed using GAD-7 and PHQ-9, respectively. Overall cancer-related QoL and lung cancer-specific QoL were assessed using QLQC-30 and QLQ-LC13, respectively. Hierarchical generalized linear models were used to estimate differences in changes in mean scores (difference-in-difference [DiD]) and odds ratios for improvement and deterioration in these patient-reported outcomes from baseline to 3 and 6/8 months between the intervention and control groups. Results: Participants in the intervention group had a significant decrease in mean total anxiety (-0.31, 95% CI: -1.18 to -0.56) and depression (-1.07, 95% CI: -2.03 to -0.11) scores at 6/8 months whereas no significant changes were detected in participants in the control group. However, no significant difference was detected between the two groups. For overall cancer-related QoL, intervention participants improved emotional functioning (4.99, 95% CI: 0.90 to 9.09) and reduced financial difficulties (-6.61, 95% CI: -12.17, -1.05) where control participants reduced fatigue (-5.93, 95% CI: -11.22, -0.64), nausea and vomiting (-5.66, 95% CI: -9.49, -1.83), appetite loss (-7.40, 95% CI: -14.18, -0.61), and constipation (-8.26, 95% CI: -14.38, -2.13) at 6/8 months. Compared to the intervention group, controls had a greater reduction in nausea and vomiting from baseline to 6/8 months [DiD]: 6.16, 95% CI: 0.63 to 11.7). For lung cancer-specific QoL, both intervention (-7.31, 95% CI: -12.69, -2.04) and control (-5.82, 95% CI: -10.78 to -0.86) participants reduced pain in chest. Compared to controls, intervention participants had a greater decrease in hemoptysis at 6/8 months (DiD: −3.39, 95% CI: −6.55 to −0.23). No significant differences were observed for global health status, functioning scales, other symptom scales, and financial difficulties between the two groups. Conclusions: A 6-month medically tailored meals plus nutrition counseling intervention did not result in significant improvements in anxiety, depression, or overall quality of life in vulnerable patients with lung cancer undergoing treatment. Clinical trial information: NCT04986670 .