NutriCare:

Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients with Lung Cancer

NutriCare will randomize 270 participants into two groups at a 1:1 ratio to an intervention or an enhanced control group. For participants randomized to the enhanced control group (n=135), the NutriTool, the oncology care team will provide participants with a nutrition toolkit involving printed educational materials. For participants randomized to the intervention group (n=135), the NutriCare, the oncology care team will additionally provide participants with a nutrition prescription, referral to registered dietitians (RDs) for remotely-delivered medical nutrition therapy counseling, and home-delivery of medically tailored meals. This project will address critical gaps in improving the nutritional status of vulnerable patients with lung cancer at the system level by achieving the following specific aims:

Aim One

To adapt an evidence-based nutrition intervention program under the 5As framework (Ask, Advise, Assess, Assist, and Arrange) – the NutriCare program – to streamline vulnerable patients with lung cancer into nutritional care; and to evaluate the implementation of integrating NutriCare into oncology care by measuring: (a) participation; (b) retention; (c) patient compliance with the intervention components; and (d) compliance of the oncology healthcare team to deliver the intervention in outpatient oncology clinics.

Aim Two

To assess the efficacy of the intervention for optimizing nutritional intake, reducing food insecurity, minimizing unintentional weight loss, improving treatment compliance, reducing treatment-related toxicities, reducing hospitalization, readmissions, and emergency department (ED) visits, and improving gut microbiome among vulnerable patients with lung cancer. We will examine: (a) change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III); (b) change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey; (c) change in weight and percent weight loss as measured in the clinic; (d) treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist; (e) treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE); (f) hospitalizations and ED visits assessed by medical record review and linkage with discharge data; and (g) change in gut microbiome via metagenomic whole shotgun sequencing (mWGS).

Aim Three

To evaluate the efficacy of the intervention for improving patient-reported outcomes among vulnerable patients with lung cancer. We will assess: (a) change in patient-reported symptoms (fatigue, pain, nausea, vomiting, appetite loss, and sleep disturbance) as assessed by a Patient-Reported Outcomes version of the CTCAE (PRO-CTCAE); (b) change in quality of life as assessed by EORTC-QLQ-30 and EORTC-QLQ-LC13; (c) change in anxiety assessed by GAD-7; and (d) change in depressive symptoms assessed by PHQ-9.