A paradigm shift is necessary to advance the current model of healthcare to cancer patients who are at high risks of malnutrition. Vulnerable patients are especially affected by malnutrition-associated poor survival and quality of life impairments due to limited access to healthcare and financial barriers to accessing nutritious foods. Leveraging the close bonds between patients with cancer and their oncology providers, this study aims for implementing and evaluating an innovative strategy to integrate nutritional care into standard oncology care.

Project Summary

The NutriCare study aims to develop, implement, and evaluate the efficacy of an innovative intervention strategy to integrate nutrition into standard oncology care on improving outcomes of the vulnerable patient population with lung cancer. The strategy adapts and implements an evidence-based framework to streamline oncology patients into nutritional care, by providing nutrition prescription, nutrition counseling, and medically tailored meals to vulnerable lung cancer patients.

The study will evaluate the efficacy of the intervention on optimizing the nutritional status, reducing treatment-related toxicities, and improving the quality of life of lung cancer patients who are economically disadvantaged, uninsured, racial and ethnic minorities, the elderly, and rural residents from four medical centers in diverse regions of the United States.

Study Design

Using a randomized controlled trial design, we aim to recruit 150 vulnerable patients with a newly diagnosed stage I-IV lung cancer from four sites (Fox Chase Cancer Center, Tufts Medical Center, M.D. Anderson Cancer Center, and Ohio State University) and randomize them equally into an intervention group (NutriCare) and an enhanced control group (NutriTool). 

NutriCare Overview

Following a 5As framework, oncology care providers will assess patients’ nutritional needs using a Nutrition Assessment for Cancer Patients Form (Ask), and advise patients to follow evidence-based nutrition recommendations using a Nutrition Prescription (Advise). Providers will further refer patients to oncology RDs who will assess patients’ individual nutritional needs along with treatment plan, and their ambivalence regarding behavior change (Assess). The RDs will assist patients with individualized goal setting (Assist) as part of the Nutrition Prescription. Providers will subsequently refer patients to RDs for remotely-delivered Nutrition Counseling and home delivery of Medically Tailored Meals and arrange follow-up visits (Arrange). 

Outcomes

This project will generate key findings to inform health policy change to advocating for full integration of nutrition care into the current standard of care for vulnerable cancer patients. Subsequent large implementation trials and cost-effectiveness assessments will validate our findings and reinforce the message. 

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:
     • Eligible at diagnosis for up to 6 weeks after: 1) starting multimodality therapy with combination chemoradiation or chemoradiation followed by surgery; or 2) starting adjuvant therapy after lung resection (chemotherapy alone or chemotherapy followed by radiation therapy)
   • Patients with stage IV lung cancer or recurrent/metastatic:
     • Eligible at diagnosis and for up to 3 months after starting treatment
   • 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.

Funding Agency:

Bristol-Myer Squibb Foundation Project