Medically Tailored Meals for Lung Cancer

Not currently 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how medically tailored meals (MTMs) and nutrition counseling can improve well-being and treatment management for people with lung cancer. The focus includes enhancing nutrition, reducing cancer treatment side effects, and improving quality of life. Participants will either receive home-delivered meals and counseling or just educational materials. Suitable candidates include those recently diagnosed with lung cancer who are economically disadvantaged, uninsured, minorities, elderly, or living in rural areas. As an unphased trial, this study provides a unique opportunity to explore supportive care options that could significantly enhance well-being during treatment.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this intervention strategy is safe for lung cancer patients?

Research shows that medically tailored meals (MTMs) are generally safe for patients. Studies have found that these meals can improve health by reducing hospital visits and lowering healthcare costs. Importantly, no major safety issues have been reported with MTMs. Previous research suggests that MTMs might also help manage side effects from treatments, making them a promising option for lung cancer patients.

Overall, MTMs are well-tolerated. They are designed to meet the specific nutritional needs of patients, which could help improve their overall well-being. While more research is always helpful, current evidence supports the safety and potential benefits of MTMs for those considering participation in a clinical trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike traditional treatments for lung cancer that focus primarily on chemotherapy, radiation, and surgery, medically tailored meals (MTMs) offer a unique approach by addressing nutritional needs alongside medical care. Researchers are excited about MTMs because they provide personalized nutrition plans that can improve overall health and potentially enhance the effectiveness of conventional cancer treatments. The NutriCare arm goes a step further by including remote counseling from registered dietitians and home-delivered meals, making it easier for patients to access specialized nutrition without additional stress. This holistic approach is innovative, as it integrates dietary support directly into cancer care, potentially improving patient outcomes and quality of life.

What evidence suggests that this trial's treatments could be effective for lung cancer?

Research has shown that specially prepared meals for medical needs, known as medically tailored meals (MTMs), can benefit lung cancer patients. These meals aim to improve nutrition and reduce treatment side effects. In this trial, participants in the NutriCare arm will receive MTMs along with nutritional counseling, which has helped patients maintain a healthy weight and respond better to treatment. Studies have found that MTMs can reduce healthcare needs in high-risk patients, offering hope for those with diet-related issues like lung cancer. Together, these approaches have been linked to a better quality of life and improved treatment outcomes for cancer patients. ^{1 2 4 6 7}

Who Is on the Research Team?

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

Principal Investigator

Ohio State University

FangFang Zhang, MD, PhD

Principal Investigator

Tufts University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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).

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10862975/

How a Medically Tailored Meal Intervention with Intensive ... These findings provide evidence that a food is medicine intervention may buffer some of the adversity related to the diagnosis of lung cancer and create a ...

2. jandonline.org jandonline.org/article/S2212-2672(25)00293-X/fulltext

Adherence to Medically Tailored Meals and Nutrition ... No significant differences were found by baseline characteristics. Lung cancer patients in a FIM intervention had high adherence to nutrition counseling but ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT04986670

NutriCare Plus a Medically Tailored Meal Intervention ... The NutriCare study evaluates the efficacy of the intervention on optimizing nutritional status, reducing treatment-related toxicities, and improving the ...

4. healthaffairs.org healthaffairs.org/doi/10.1377/hlthaff.2024.01307

Estimated Impact Of Medically Tailored Meals On ... Medically tailored meals (MTMs) can reduce health care use among high-risk patients with diet-related conditions.

5. healthcarexfood.org healthcarexfood.org/en/knowledge-hub/publication-hub/medically-tailored-meals-in-lung-cancer-care

Medically tailored meals in lung cancer care The NutriCare Clinical Trial evaluated the impact of medically tailored meals (MTMs) and remote nutrition counseling on vulnerable patients with lung cancer.

6. journals.lww.com journals.lww.com/lww-medicalcare/fulltext/2022/10000/effect_of_medically_tailored_meals_on_clinical.4.aspx

Effect of Medically Tailored Meals on Clinical Outcomes in... The purpose of this study is to evaluate whether medically tailored meals (MTMs) improve outcomes in recently discharged adults with nutrition-sensitive ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9451942/

Effect of Medically Tailored Meals on Clinical Outcomes in ... The purpose of this study is to evaluate whether medically tailored meals (MTMs) improve outcomes in recently discharged adults with nutrition-sensitive ...