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NCT04986670Active, not recruiting

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2025

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
299 (actual)
First submitted
13 Jul 2021
Start date
24 Nov 2020
Primary completion date
31 Dec 2024
Lead sponsor
Tufts University
Diseases
Lung cancer
NCT number
NCT04986670

What you commit to

  • Study type: Interventional
  • Participants enrolled: 299
  • From 24 Nov 2020 to the primary completion date, 31 Dec 2024
  • 4 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • 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).

Other

  • Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program.
  • 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.

Who the study is looking for

  • 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:
    • 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
  • 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.

Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (4)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Tufts Medical Center
Coordinator of this site? Confirm its status
BostonUnited StatesUnknown status
The James Cancer Hospital
Coordinator of this site? Confirm its status
ColumbusUnited StatesUnknown status
MD Anderson Cancer Center
Coordinator of this site? Confirm its status
HoustonUnited StatesUnknown status
Fox Chase Cancer Center
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.