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Active, Not Recruiting

NCT Number: NCT04986670

NutriCare Plus a Medically Tailored Meal Intervention Among 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Lung Cancer, Small Cell Bronchial Neoplasms Carcinoma, Bronchogenic Carcinoma, Non-Small-Cell Lung Lung Cancer Metastatic Lung Cancer Recurrent Lung Cancer, Non-small Cell Lung Diseases Lung Neoplasms Malnutrition Neoplasms Neoplasms by Site Nutrition Disorders Nutritional Imbalance Nutritional and Metabolic Diseases Respiratory Tract Diseases Respiratory Tract Neoplasms Small Cell Lung Carcinoma Thoracic Neoplasms Treatment Side Effects

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tufts Medical Center, Boston, Massachusetts, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.
  • 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

  • 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.

Treatment and study plan

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.

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.

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.

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).

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.

Monthly Emails

Behavioral

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

Primary outcomes

  1. Nutritional Intake

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

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

  2. Weight

    Time frame: 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.

    Change in weight measured in the clinic

Secondary outcomes

  1. Food Insecurity

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

    Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey

  2. Patient-reported Symptoms

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

    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)

  3. Patient-reported Functional Outcomes - Anxiety

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

    Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by General Anxiety Disorder-7 (GAD-7). The total score for the seven items ranges from 0 to 21 (0-4: minimal anxiety. 5-9: mild anxiety. 10-14: moderate anxiety. 15-21: severe anxiety).

  4. Patient-reported Functional Outcomes - Depression

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

    Change in patient-reported functional outcomes (physical, social, and cognitive functioning) assessed by Patient Health Questionnaire-9 (PHQ-9). The total score for the nine items ranges from 0 to 27 (0-4: no depression, 5-9: mild depression, 10-14: moderate depression, 15-19: moderately severe depression, 20-27: severe depression).

  5. Health-Related Quality of Life in Cancer Patients

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

    Change in quality of life as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (EORTC-QLQ-30). All of the scales and single-item measures range in score from 0 to100. A high scale score represents a higher response level. Thus a high score for a functional scale represents a high/healthy level of functioning, a high score for the global health status/QoL represents a high QoL, but a high score for a symptom scale/item represents a high level of symptomatology/problems.

  6. Quality of Life in Lung Cancer Patients

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

    Change in quality of life as assessed by the European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire lung cancer module (EORTC-QLQ-LC13). All of the scales and single-item measures range in score from 0 to 100. A high score for the scales and single items represents a high level of symptomatology or problems.

  7. Hospitalizations

    Time frame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.

    Rate of hospitalizations will assessed by medical record review and linkage with discharge data

  8. ED visits

    Time frame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.

    Rate of ED visits assessed by medical record review and linkage with discharge data

  9. Treatment-related Toxicities

    Time frame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.

    Rate of treatment-related toxicities assessed by the treating medical oncologist using the National Cancer Institute (NCI) Common Toxicity Criteria for Adverse Events (CTCAE)

  10. Treatment Compliance

    Time frame: 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 completion (dose reductions and treatment delays) assessed by the treating medical oncologist

  11. Gut Microbial Composition

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

    Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)

  12. Cancer Mortality

    Time frame: 5-8 Years

    National Death Index search performed approximately 5 years after the final patient is enrolled.

Other outcomes

  1. MTM Program Implementation

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

    Nutrition counseling adherence (rate of attendance)

Sponsors and collaborators

Lead sponsor

Tufts University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2024
Study completion
2026
First posted
Aug 3, 2021
Registry last updated
Sep 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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