Medically Tailored Meals for Pediatric Cancer

(MTM-Kids Trial)

Overseen By Andrew Smitherman, MD

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether delivering healthy, frozen meals to families provides helpful and welcome support during a child's cancer treatment. It targets children aged 12 to 17 who have completed at least one round of chemotherapy and are scheduled for more. The meals, known as Medically Tailored Meals, are customized to the child’s condition and include condiments for a personal touch. This trial is available to children treated at the University of North Carolina and their primary parental caregivers who speak English or Spanish. As an unphased trial, it offers families a unique opportunity to receive nutritional support tailored to their child's needs during treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What prior data suggests that medically tailored meals are safe for children undergoing cancer treatment?

Research has shown that specific safety information about medically tailored meals for children with cancer is lacking. However, similar nutrition programs have generally been well-received. Studies in adults indicate that these meals can improve health without major side effects. Specially designed to meet dietary needs, they are a safe choice for most people. As this study focuses on nutrition, the risk of side effects is lower compared to treatments involving medication. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard of care for pediatric cancer, which typically relies on medications and chemotherapy to fight the disease, medically tailored meals focus on supporting the child's overall health and wellbeing during treatment. Researchers are excited about these meals because they provide personalized nutrition that can help reduce treatment side effects and improve recovery. This approach is unique as it delivers up to 10 healthy, frozen meals weekly, customized with condiments for individual preferences, potentially enhancing the child's strength and energy levels during the tough chemotherapy process.

What evidence suggests that medically tailored meals might be an effective treatment for pediatric cancer?

Research has shown that meals specifically designed for medical needs can improve health. For adults, these meals link to better health and lower healthcare costs. In children with long-term health issues, one study found that two weeks of these meals significantly reduced anxiety. Although limited data exists for children with cancer, positive results in other groups suggest potential benefits. In this trial, participants will receive medically tailored meals designed to support health by meeting specific dietary needs during cancer treatment. ^{3 5 6 7 8}

Who Is on the Research Team?

Sheila J. Santacroce

Principal Investigator

University of North Carolina, Chapel Hill

Are You a Good Fit for This Trial?

This trial is for children undergoing treatment for serious illnesses, specifically pediatric cancer. It aims to support the child and their primary caregiver by providing medically tailored meals for 12 weeks.

Inclusion Criteria

I am between 12 and 17 years old.

Eligible children will be under the care of The University of North Carolina at Chapel Hill School of Medicine, Department of Pediatrics, Division of Pediatric Hematology/Oncology

My child is expected to undergo at least two more treatment cycles.

Exclusion Criteria

None if inclusion criteria are met

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive medically tailored meals for 12 weeks during the child's treatment for serious illness

12 weeks

Weekly meal deliveries

Follow-up

Participants are monitored for changes in food-related insecurities, cost coping, parental role demands, and financial well-being

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Medically Tailored Meals

Trial Overview The study is testing the feasibility and acceptability of delivering healthy, frozen meals that are specially prepared to meet the dietary needs related to a child's illness during their treatment period.

How Is the Trial Designed?

Group I: Medically-tailored meals for children being treated for cancer with chemotherapy Experimental Treatment 1 Intervention

The intervention will be 12-weeks induration, with weekly "doses" (meal deliveries) of up to 10 healthy, frozen meals per week for household use as needed, plus selected condiments for personalization.

Who Is Running the Clinical Trial?

UNC Lineberger Comprehensive Cancer Center

Lead Sponsor

Trials

377

Recruited

95,900+

National Institute of Nursing Research (NINR)

Collaborator

Trials

623

Recruited

10,400,000+

Published Research Related to This Trial

This scoping review analyzed 9 studies on malnutrition in pediatric cancer treatment, revealing that various nutritional interventions, such as appetite stimulants and supplements, can lead to improved weight outcomes, although the specific methods used showed no significant differences in effectiveness.

The review highlighted a lack of standardized definitions and screening tools for malnutrition, indicating that while some screening methods may reduce malnutrition risk and improve weight gain, there is a critical need for consistent assessment and treatment strategies in pediatric oncology.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. Franke, J., Bishop, C., Runco, DV.[2022]

Implementing national coverage for medically tailored meals (MTMs) could potentially prevent approximately 1.6 million hospitalizations and save $13.6 billion in health care costs annually for patients with diet-related diseases.

Over a 10-year period, MTM coverage could lead to an estimated 18.3 million averted hospitalizations and $484.5 billion in reduced health care expenditures, highlighting the significant cost-effectiveness of this intervention for patients with chronic diet-sensitive conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Association of National Expansion of Insurance Coverage of Medically Tailored Meals With Estimated Hospitalizations and Health Care Expenditures in the US. Hager, K., Cudhea, FP., Wong, JB., et al.[2023]

A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety and depression scores compared to baseline, while the 4-week group did not show similar improvements.

However, there were no significant differences in overall patient outcomes, such as activities of daily living, nutritional risk, or rates of emergency department visits and rehospitalizations, between the 2-week and 4-week MTM groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. Boxer, R., Drace, ML., Kelly, C., et al.[2023]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40743050/

Study protocol: Feasibility of medically tailored meals for ... Medically-tailored meals (MTM) have shown promise in improving health outcomes in adults with diet-sensitive conditions, but their feasibility ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT06814795

NCT06814795 | Medically Tailored Meals for Kids Children living in poverty with associated adverse SDOH are less likely survive either highly treatable cancers, or high-risk cancers that require regimens with ...

3. journals.plos.org journals.plos.org/plosone/article?id=10.1371/journal.pone.0326762

Feasibility of medically tailored meals for pediatric populations ... The study will provide critical insights into the feasibility of implementing medically tailored meals for pediatric oncology and other patients ...

4. withpower.com withpower.com/trial/medically-tailored-meals-for-pediatric-cancer-ca0f8

Medically Tailored Meals for Pediatric Cancer (MTM-Kids ... A study involving 650 patients with chronic conditions found that receiving medically tailored meals (MTM) for 2 weeks led to a significant reduction in anxiety ...

5. reporter.nih.gov reporter.nih.gov/search/LmkjcBGHE0aE4YLy1ZsD3Q/project-details/10951201

RePORT RePORTER - National Institutes of Health (NIH) | In studies of adults with health conditions, MTM interventions were associated with better health outcomes and less health care spending. We extend the MTM ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06814795

NCT06814795 | Medically Tailored Meals for Kids In pediatric cancer, one approach being studied to address outcome disparities driven by food-related insecurities is to provide the household with gift ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12312939/

Feasibility of medically tailored meals for pediatric populations ... Medically-tailored meals (MTM) have shown promise in improving health outcomes in adults with diet-sensitive conditions, but their feasibility ...

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

Estimated Impact Of Medically Tailored Meals On ... This study investigated the one-year and five-year effects of implementing MTMs in US states on hospitalizations, health care expenditures, and net costs.