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

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer, Small Cell; Treatment Side Effects; Lung Cancer Metastatic; Lung Cancer Recurrent; Lung Cancer, Non-small Cell; Nutritional Imbalance
• Interventions: Behavioral: Nutritional Counseling; Other: Medically Tailored Meals (MTMs); Behavioral: Nutrition Prescription; Other: Nutrition Assessment; Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails

• Registration Number: NCT04986670
• Lead Sponsor: Tufts University

Brief 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. 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-11-24
• Study First Submitted: 2021-07-13
• Study First Submitted QC: 2021-07-30
• Study First Posted: 2021-08-03
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-22
• Last Update Posted: 2024-04-24
• Primary Completion: 2024-08-30
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 299

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
NutriCare	Nutrition Prescription	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.
NutriCare	Nutrition Toolkit	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.
NutriCare	Nutritional Counseling	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.
NutriCare	Medically Tailored Meals (MTMs)	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.
NutriTool	Nutrition Toolkit	The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.
NutriCare	Nutrition Assessment	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.
NutriCare	Monthly Emails	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.
NutriTool	Monthly Emails	The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.

Primary Outcome Measures

Name	Time	Method
Nutritional Intake	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)
Weight	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 and percent weight loss as measured in the clinic

Secondary Outcome Measures

Name	Time	Method
Patient-reported Functional Outcomes	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 PHQ-9
Treatment-related Toxicities	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)
Food Insecurity	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
Cancer Mortality	5-8 Years	National Death Index search performed approximately 5 years after the final patient is enrolled.
Patient-reported Symptoms	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)
Patient quality of life	Baseline, 3-month, and 6 months [for cohort 2] or 8 months [for cohort 1]	Change in quality of life as assessed by EORTC-QLQ-LC13
Hospitalizations	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
ED visits	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
Treatment Compliance	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
Gut Microbial Composition	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)

Trial Locations

Locations (4)

MD Anderson Cancer Center; 🇺🇸 Houston, Texas, United States

Tufts Medical Center; 🇺🇸 Boston, Massachusetts, United States

Fox Chase Cancer Center; 🇺🇸 Philadelphia, Pennsylvania, United States

The James Cancer Hospital; 🇺🇸 Columbus, Ohio, United States