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

Tufts University

Status: Active, not recruiting

Conditions: Lung Cancer, Small Cell; Lung Cancer Metastatic; Treatment Side Effects; Nutritional Imbalance; Lung Cancer, Non-small Cell; Lung Cancer Recurrent

Treatments: Behavioral: Nutritional Counseling; Other: Medically Tailored Meals (MTMs); Other: Nutrition Assessment; Behavioral: Nutrition Prescription; Behavioral: Nutrition Toolkit; Behavioral: Monthly Emails

Study type: Interventional

Funder types: Other

Identifiers

NCT04986670

STUDY00000203

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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.

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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299 participants in 2 patient groups

NutriCare

Experimental group

Description:

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.

Treatment:

Behavioral: Nutrition Toolkit

Behavioral: Nutritional Counseling

Behavioral: Monthly Emails

Other: Nutrition Assessment

Other: Medically Tailored Meals (MTMs)

Behavioral: Nutrition Prescription

NutriTool

Active Comparator group

Description:

The oncology care team will provide participants with a nutrition toolkit involving printed educational materials.

Treatment:

Behavioral: Nutrition Toolkit

Behavioral: Monthly Emails