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Lung Cancer, Small CellNCT04986670

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

A study testing Nutritional Counseling, Medically Tailored Meals (MTMs) and Nutrition Prescription in people with Lung Cancer, Small Cell and Lung Cancer Metastatic, run by Tufts University at 4 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 100 years
What is being tested?
Nutritional Counseling, Medically Tailored Meals (MTMs) and Nutrition Prescription
Could I receive a placebo?
No, everyone receives an active treatment
How many people
299 participants
Where
4 sitesUnited States
Study dates
24 Nov 2020to 31 Dec 2026
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 100 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 16Show fewer
  • 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.

Who cannot join

  • 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.

Trial locations and contacts

4 sites in 1 country.

United States4 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • The James Cancer Hospital

    Columbus, Ohio, 43210

  • MD Anderson Cancer Center

    Houston, Texas, 77030

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

Other trials in United States

About this study

Official title: 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.

Being tested
Nutritional Counseling, Medically Tailored Meals (MTMs), Nutrition Prescription, Nutrition Assessment, Nutrition Toolkit
Keywords
lung cancer, malnutrition, vulnerability, medically tailored meals, nutrition counseling
Medical subject headings
Small Cell Lung Carcinoma, Carcinoma, Non-Small-Cell Lung, Lung Neoplasms, Malnutrition

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nutritional CounselingBehavioural

    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 PrescriptionBehavioural

    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 AssessmentOther

    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 ToolkitBehavioural

    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 EmailsBehavioural

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

Study groups in NCT04986670
Study groupRoleWhat they receive
NutriCareExperimentalThe 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.
Receives: Behavioral: Nutritional Counseling; Other: Medically Tailored Meals (MTMs); Behavioral: Nutrition Prescription; Other: Nutrition Assessment; Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails
NutriToolActive comparatorThe oncology care team will provide participants with a nutrition toolkit involving printed educational materials.
Receives: Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

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

  2. Weight

    Change in weight measured in the clinic

    Measured: 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)

  1. Food Insecurity

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

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

  2. 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)

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

  3. Patient-reported Functional Outcomes - Anxiety

    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).

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

  4. Patient-reported Functional Outcomes - Depression

    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).

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

  5. Health-Related Quality of Life in Cancer Patients

    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.

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

  6. Quality of Life in Lung Cancer Patients

    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.

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

  7. Hospitalizations

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

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

  8. ED visits

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

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

  9. 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)

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

  10. Treatment Compliance

    Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist

    Measured: 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.

  11. Gut Microbial Composition

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

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

  12. Cancer Mortality

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

    Measured: 5-8 Years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Aug 2021
  2. Study start24 Nov 2020
  3. Primary completion31 Dec 2024
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Model description
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.
Masking
None (open label)
Enrolment
299 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04986670
Sponsor's protocol ID
STUDY00000203
Status last verified
Sep 2025
First submitted
13 Jul 2021
Last updated
30 Sep 2025
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Nutritional Counseling, Medically Tailored Meals (MTMs) and Nutrition Prescription in people with Lung Cancer, Small Cell and Lung Cancer Metastatic, run by Tufts University at 4 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 30 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Nutritional Intake (time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04986670.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Sep 2025; AzTrials last refreshed its copy on 6 Nov 2026.

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