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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Lung Cancer Metastatic; Lung Cancer, Non-small Cell; Treatment Side Effects; Lung Cancer, Small Cell; Lung Cancer Recurrent; Nutritional Imbalance
• Intervention / Treatment: Behavioral: Nutrition Prescription; Other: Nutrition Assessment; Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails; Behavioral: Nutritional Counseling; Other: Medically Tailored Meals (MTMs)

• Study Type: Interventional
• Enrollment (Actual): 299
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Fang Fang Zhang, MD,PhD; Phone Number: 6176363706; Email: Fang_Fang.zhang@tufts.edu
• Study Contact Backup: Name: Mary Cohen, MS,RD; Email: mary_kathryn.cohen@tufts.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The James Cancer Hospital
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19111
      • Fox Chase Cancer Center
  • Texas
    • Houston, Texas, United States, 77030
      • MD Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NutriCare; 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: 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.; 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.
Active Comparator: NutriTool; The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 and percent weight loss as 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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Compliance	Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist	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.
Treatment-related Toxicities	Rate of treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)	From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Hospitalizations	Rate of hospitalizations will assessed by medical record review and linkage with discharge data	From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
ED visits	Rate of ED visits assessed by medical record review and linkage with discharge data	From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Patient-reported Symptoms	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)	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Patient quality of life	Change in quality of life as assessed by EORTC-QLQ-30	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Patient quality of life	Change in quality of life as assessed by EORTC-QLQ-LC13	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Patient-reported Functional Outcomes	Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by GAD-7	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Patient-reported Functional Outcomes	Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by PHQ-9	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Food Insecurity	Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Gut Microbial Composition	Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Cancer Mortality	National Death Index search performed approximately 5 years after the final patient is enrolled.	5-8 Years

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Program Implementation	(a) participation; (b) retention; (c) compliance	From consent through study completion, 6 months [for cohort 2] or 8 months [for cohort 1]

Collaborators and Investigators

• Sponsor: Tufts University
• Collaborators: M.D. Anderson Cancer Center; Fox Chase Cancer Center; Ohio State University; Tufts Medical Center
• Investigators: Principal Investigator: FangFang Zhang, MD, PhD, Tufts University; Principal Investigator: Colleen Spees, PhD, MEd, RD, LD, FAND, Ohio State University

Publications and helpful links

Helpful Links

• NutriCare Study Website

Study record dates

Study Major Dates

• Study Start (Actual): November 24, 2020
• Primary Completion (Estimated): August 30, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: July 13, 2021
• First Submitted That Met QC Criteria: July 30, 2021
• First Posted (Actual): August 3, 2021

Study Record Updates

• Last Update Posted (Actual): April 24, 2024
• Last Update Submitted That Met QC Criteria: April 22, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: lung cancer; malnutrition; vulnerability; nutrition counseling; medically tailored meals
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung; Small Cell Lung Carcinoma
• Other Study ID Numbers: STUDY00000203

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No