Medically Tailored Meals for Lung Cancer

Recruiting at 3 trial locations

Overseen By Fang Fang Zhang, MD,PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tufts University

Disqualifiers: Cognitive impairment, Metabolic illnesses, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

299 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Colleen Spees, PhD, MEd, RD, LD, FAND

Principal Investigator

Ohio State University

FangFang Zhang, MD, PhD

Principal Investigator

Tufts University

Eligibility Criteria

The NutriCare trial is for vulnerable lung cancer patients who are economically disadvantaged, uninsured, belong to racial and ethnic minorities, elderly, or live in rural areas. They must be adults newly diagnosed with either small cell or non-small cell lung cancer and able to participate fully in the study.

Inclusion Criteria

People who are economically disadvantaged, from minority racial or ethnic groups, do not have health insurance, are elderly, or live in rural areas.

You have an Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 3.

You have recently been diagnosed with non-small cell or small cell lung cancer and meet certain treatment requirements.

Exclusion Criteria

Cognitively unable to consent or have physical or mental limitations that would prevent full participation in the program

Unable to receive medically-tailored meals for the course of the study if being assigned to the intervention arm

You have health problems that affect how your body digests food or uses energy.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive medically tailored meals and nutrition counseling to improve nutritional status and quality of life

6-8 months

3-4 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the intervention

4 weeks

Long-term Follow-up

National Death Index search performed approximately 5 years after the final patient is enrolled to assess cancer mortality

5-8 years

Treatment Details

Interventions

• Medically Tailored Meals (MTMs)
• Monthly Emails
• Nutritional Counseling
• Nutrition Assessment
• Nutrition Prescription
• Nutrition Toolkit

Trial Overview This study tests a combination of medically tailored meals and nutrition counseling designed to improve nutritional status, reduce side effects from treatment, and enhance quality of life among lung cancer patients. Participants will be divided into two groups receiving interventions for different durations (8 months or 6 months).

Participant Groups

Group I: NutriCare Experimental Treatment 6 Interventions

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.

Group II: NutriTool Active Control 2 Interventions

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

Who Is Running the Clinical Trial?

Tufts University

Lead Sponsor

Trials

271

Recruited

595,000+

Ohio State University

Collaborator

Trials

891

Recruited

2,659,000+

Tufts Medical Center

Collaborator

Trials

264

Recruited

264,000+

M.D. Anderson Cancer Center

Collaborator

Trials

3,107

Recruited

1,813,000+

Fox Chase Cancer Center

Collaborator

Trials

236

Recruited

39,300+