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NCT04986670

NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer

Sponsor: Tufts University

View on ClinicalTrials.gov

Summary

The NutriCare study aims to develop, implement, and evaluate the efficacy of an innovative intervention strategy (medically tailored meals plus nutrition counseling) to integrate nutrition into the standard of care for oncology to improve outcomes of vulnerable patients with lung cancer. The NutriCare study evaluates the efficacy of the intervention on optimizing nutritional status, reducing treatment-related toxicities, and improving the quality of life of patients with lung cancer who are economically disadvantaged, uninsured, racial and ethnic minorities, elderly, and/or rural residents from four major medical centers in diverse regions of the United States (U.S.). There will be two cohorts for NutriCare with cohort 1 recruiting 150 patients completing an 8-month intervention and cohort 2 recruiting 120 patients completing a 6-month intervention.

Official title: NutriCare Intervention on Optimizing Nutritional Status, Reducing Treatment-Related Toxicities, and Improving Quality of Life Among Vulnerable Patients With Lung Cancer

Key Details

Gender

All

Age Range

18 Years - 100 Years

Study Type

INTERVENTIONAL

Enrollment

299

Start Date

2020-11-24

Completion Date

2026-12-31

Last Updated

2025-09-30

Healthy Volunteers

Conditions

Lung Cancer, Small Cell Lung Cancer Metastatic Lung Cancer Recurrent Treatment Side Effects Lung Cancer, Non-small Cell Nutritional Imbalance

Interventions

BEHAVIORAL

Nutritional Counseling

Medical oncology providers will refer participants to oncology RDs for remotely delivered medical nutrition therapy counseling. For cohort 1, participants will receive nutrition counseling for 8 months. The counseling will be provided on a weekly basis during the first 6 months and every other week during the last 2 months (for cohort 1 only). For cohort 2, participants will receive nutrition counseling for 6 months. The ultimate frequency of nutrition counseling being provided to each participant will also be adjusted according to the participant's preference and needs.

OTHER

Medically Tailored Meals (MTMs)

Medically tailored meals will be provided to participants in the intervention group for a total of 24 weeks for both cohorts. During the first 8 weeks of the intervention, 3 meals/day will be provided each week for a total of 168 meals per participant. It will be followed by less frequent meal provision during the subsequent 16 weeks following this schedule: 3 meals/day will be provided every other week for the next 8 weeks (a total of 84 meals per participant); and 3 meals/day will be provided every four weeks during the last 8 weeks (a total of 42 meals per participant). The number of meals provided to each participant may be adjusted according to participant's preference and needs.

BEHAVIORAL

Nutrition Prescription

Oncology providers will advise participants with lung cancer to follow evidence-based nutrition recommendations using a Nutrition Prescription. The Nutrition Prescription aims to enhance providers' role in communicating basic nutrition advice to participants with lung cancer. It contains seven recommendations, adapted from the newly released Cancer Prevention Recommendations by WCRF/AICR with strong evidence-base.

OTHER

Nutrition Assessment

Oncology care providers will assess the nutritional status of patients with lung cancer using PG-SGA Short Form (the Scored Patient-Generated Subjective Global Assessment). PG-SGA is an interdisciplinary patient assessment in oncology and other chronic catabolic conditions. The short form contains four patient generated historical components (weight history, food intake symptoms, and activities and function).

BEHAVIORAL

Nutrition Toolkit

Patients will receive a printed copy of a Nutrition Toolkit from providers. Evidence-based nutrition recommendations have been compiled for cancer survivors from 4 sources into a Nutrition Toolkit. The sources include: (1) AmericanCancer Society (ACS) Nutrition and Physical Activity Guidelines for Cancer Survivors; (2)World Cancer Research Fund / American Institute for Cancer Research (WFRF/AICR) Cancer Nutrition Guide; (3) National Cancer Institute (NCI) Eating Hints; and (4) National Comprehensive Cancer Network (NCCN) Guidelines for Cancer Survivors. The Nutrition Toolkit outlines topics about the impact of cancer treatment on dietary intake patterns and quality, strategies to manage treatment-related eating issues, maintaining a healthy weight post treatment, and evidence-based recommendations and practical. Nutrition Toolkit strategies for improving diet quality and maintaining an optimal weight for cancer survivors.

BEHAVIORAL

Monthly Emails

Monthly emails will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.

Inclusion Criteria: 1. Adults (18+ years of age) 2. Newly diagnosed patients with lung cancer (non-small cell and small cell lung cancer): * Patients with stages I-III lung cancer: 1\) starting multimodality therapy including chemoradiation (either concurrent or sequential), systemic treatment, or radiation alone; and may be followed by surgery; or 2) starting adjuvant therapy after lung resection ((chemotherapy alone, radiation alone, or chemoradiation (either concurrent or sequential)) * Patients with stage IV lung cancer or recurrent/metastatic: Eligible at diagnosis and for up to 3 months after starting treatment o Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) 0-3 3. Vulnerable patients who meet at least one of the following criteria: * Economically disadvantaged (household gross monthly income at or below 130% of the Federal Poverty Level) * Racial and ethnic minorities (African Americans, American Indians and Alaska Natives, Asians and Pacific Islanders, and Hispanics) * No health insurance * Elderly patients (ages 65 years or older) * Reside in rural areas (non-metropolitan counties with less than 50,000 people) 4. Voluntarily provide consent, HIPPA authorization form, and consent from treating oncologist. 5. Able to speak and read English themselves or with minimal help. 6. Able to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, and willing to sign the MTM agreement. Exclusion Criteria: 1. Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program. 2. Have medical conditions that significantly impact digestion, metabolism, or food intake (e.g., surgical loss of esophagus, stomach, or colon; pancreas dysfunction; brain surgery that alters cognition; severe food allergies; etc.) or have active metabolic or digestive illnesses (i.e., Celiac disease, IBS, renal insufficiency, hepatic insufficiency). 3. Pregnant or planning to become pregnant during the study. 4. Unable to receive medically-tailored meals for the course of the study if being assigned to the intervention arm, including lack of a permanent address to which meals can be delivered (a friend or home address is acceptable given it is used on a consistent basis), not having a fully functioning kitchen with a microwave or oven for cooking, not having a standard-sized refrigerator with a freezer with storage capacity to hold one week's worth of meals; or unwilling to sign the MTM agreement.

Locations (4)

Tufts Medical Center

Boston, Massachusetts, United States

The James Cancer Hospital

Columbus, Ohio, United States

Fox Chase Cancer Center

Philadelphia, Pennsylvania, United States

MD Anderson Cancer Center

Houston, Texas, United States

Clinical Research Directory

NutriCare Plus a Medically Tailored Meal Intervention Among Patients With Lung Cancer

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (4)