An interventional study of Nutritional Counseling and Medically Tailored Meals (MTMs) in Lung Cancer, Small Cell, Lung Cancer Metastatic and Lung Cancer Recurrent, sponsored by Tufts University. Active, not recruiting at 4 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2025-09-30.
Sponsored by Tufts University · Not applicable, Interventional, and Supportive care
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.
1,203 studies on the registry are indexed under Small Cell Lung Carcinoma; 342 are open to participants now.
This study's enrollment of 299 is above the median of 56 across 1,031 interventional studies indexed under Small Cell Lung Carcinoma.
Browse Small Cell Lung Carcinoma studies →Tufts University is the lead sponsor of 225 studies on the registry; 24 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 7 (70%) have results posted.
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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))
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:
Exclusion Criteria:
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
The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.
Behavioral: Nutrition Toolkit · Behavioral: Monthly Emails
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 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.
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.
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).
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 will be sent to participants to encourage the use of the toolkit with healthy recipes and general nutrition information.
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)
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Weight
Change in weight measured in the clinic
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.
Food Insecurity
Change in food insecurity measured by the U.S. Department of Agriculture (USDA) Household Food Security Survey
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
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)
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
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).
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
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).
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
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.
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
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.
Time frame: Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]
Hospitalizations
Rate of hospitalizations will assessed by medical record review and linkage with discharge data
Time frame: 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
Time frame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
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)
Time frame: From baseline until the date of completing the 6 months [for cohort 2] or 8 months [for cohort 1] study visit.
Treatment Compliance
Treatment completion (dose reductions and treatment delays) assessed by the treating medical oncologist
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.
Gut Microbial Composition
Change in gut microbiome via metagenomic whole shotgun sequencing (mWGS)
Time frame: 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.
Time frame: 5-8 Years
MTM Program Implementation
Nutrition counseling adherence (rate of attendance)
Time frame: From consent through study completion, 6 months [for cohort 2] or 8 months [for cohort 1]
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