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

NCT04986670 | Active Not Recruiting

• 1 other identifier: STUDY00000203
• Study Type: interventional
• Target: 299
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

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

Keywords

lung cancer; malnutrition; vulnerability; medically tailored meals; nutrition counseling

Outcome Measures

Primary Outcomes (2)

• Nutritional Intake

  Change in diet quality and intake of key food groups and nutrients as assessed by the National Cancer Institute Diet History Questionnaire (DHQ III)

  Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]

• Weight

  Change in weight measured in the clinic

  Recorded at each clinical visit. From date of beginning baseline until the date of completing the final (6 or 8 month) study visit, an average of 3-4 clinic visits dependent on course of treatment.

Secondary Outcomes (12)

• Food Insecurity

  Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]

• Patient-reported Symptoms

  Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]

• Patient-reported Functional Outcomes - Anxiety

  Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]

• Patient-reported Functional Outcomes - Depression

  Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]

• Health-Related Quality of Life in Cancer Patients

  Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]

Other Outcomes (1)

• MTM Program Implementation

  From consent through study completion, 6 months [for cohort 2] or 8 months [for cohort 1]

Study Arms (2)

NutriCare

EXPERIMENTAL

The oncology care team will provide participants with nutrition toolkit involving printed educational materials, a nutrition prescription, referral to registered dietitians (RDs) for remotely-delivered medical nutrition therapy counseling, and home-delivery of medically tailored meals.

Behavioral: Nutritional Counseling; Other: Medically Tailored Meals (MTMs); Behavioral: Nutrition Prescription; Other: Nutrition Assessment; Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails

NutriTool

ACTIVE COMPARATOR

The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.

Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails

Interventions

Nutritional Counseling BEHAVIORAL

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.

NutriCare

Medically Tailored Meals (MTMs) OTHER

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.

NutriCare

Nutrition Prescription BEHAVIORAL

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.

NutriCare

Nutrition Assessment OTHER

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).

NutriCare

Nutrition Toolkit BEHAVIORAL

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.

NutriCare; NutriTool

Monthly Emails BEHAVIORAL

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

NutriCare; NutriTool

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults (18+ years of age)
• Newly diagnosed patients with lung cancer (non-small cell and small cell lung cancer):
• Patients with stages I-III lung cancer:
• \) 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
• 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)
• Voluntarily provide consent, HIPPA authorization form, and consent from treating oncologist.
• Able to speak and read English themselves or with minimal help.

You may not qualify if:

• Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program.
• 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).
• Pregnant or planning to become pregnant during the study.
• 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.

Sponsors & Collaborators

• Tufts University: lead
• Fox Chase Cancer Center: collaborator
• M.D. Anderson Cancer Center: collaborator
• Ohio State University: collaborator
• Tufts Medical Center: collaborator

Study Sites (4)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

The James Cancer Hospital

Columbus, Ohio, 43210, United States

Location

Fox Chase Cancer Center

Philadelphia, Pennsylvania, 19111, United States

Location

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• NutriCare Study Website

MeSH Terms

Conditions

Small Cell Lung Carcinoma; Carcinoma, Non-Small-Cell Lung; Lung Neoplasms; Malnutrition

Interventions

Nutrition Assessment

Condition Hierarchy (Ancestors)

Carcinoma, Bronchogenic; Bronchial Neoplasms; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Nutrition Disorders; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Epidemiologic Measurements; Public Health; Environment and Public Health

Study Officials

• FangFang Zhang, MD, PhD

  Tufts University

  PRINCIPAL INVESTIGATOR

• Colleen Spees, PhD, MEd, RD, LD, FAND

  Ohio State University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, The Neely Family Professor and Associate Professor

Model Details: For the proposed study, we will randomize 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, the NutriTool, the oncology care team will provide participants with a nutrition toolkit involving printed educational materials. For participants randomized to the intervention group, the NutriCare, the oncology care team will additionally provide participants with home-delivery of medically tailored meals and referral to registered dietitians (RDs) for remotely-delivered nutrition counseling.

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: August 3, 2021
• Study Start: November 24, 2020
• Primary Completion: December 31, 2024
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 30, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)