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

30 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this project is to learn whether an intervention that provides households with home-delivered healthy, frozen meals tailored to illness related conditions for 12 weeks during a child's treatment for serious illness is feasible and acceptable to the child and parent mainly responsible for the child's care.

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 data supports the effectiveness of the treatment Medically Tailored Meals for Pediatric Cancer?

Research shows that providing appetizing and flexible meal options can help children with cancer maintain good nutrition, which is crucial for their treatment response and quality of life. Additionally, changes in food temperature, flavor, and timing can improve food acceptance in cancer patients, potentially stabilizing weight and enhancing therapy tolerance. ^{1 2 3 4 5}

Are medically tailored meals safe for children with cancer?

There is no specific safety data on medically tailored meals for children with cancer, but studies on similar nutrition interventions show they are generally well-accepted and can help maintain or improve nutritional status without significant negative effects. ^{3 5 6 7 8}

How are Medically Tailored Meals different from other treatments for pediatric cancer?

Medically Tailored Meals are unique because they provide personalized nutrition designed to meet the specific dietary needs of pediatric cancer patients, addressing malnutrition and improving quality of life, unlike standard treatments that may not focus on individualized nutrition. ^{4 7 9 10 11}

Research Team

Sheila J. Santacroce

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Important aspects of nutrition in children with cancer. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Influencing food acceptance in anorexic cancer patients. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Cook to order: meeting the nutritional needs of children with cancer in hospital. [2009]

4. England pubmed.ncbi.nlm.nih.gov

Malnutrition screening and treatment in pediatric oncology: a scoping review. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Comparing two durations of medically tailored meals posthospitalization: A randomized clinical trial. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Favorable Parental Perception of Proactive Nutrition Intervention in High-risk Pediatric Brain Tumor Population and Impact on Nutrition Outcomes. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Dietary intake and diet quality in children receiving treatment for cancer. [2020]

8. United States 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. [2023]

9. Germany pubmed.ncbi.nlm.nih.gov

Evaluation of an automated pediatric malnutrition screen using anthropometric measurements in the electronic health record: a quality improvement initiative. [2021]

10. Spain pubmed.ncbi.nlm.nih.gov

Nutritional status and adequacy of enteral nutrition in pediatric cancer patients at a reference center in northeastern Brazil. [2012]

11. United States pubmed.ncbi.nlm.nih.gov

Impact of a pediatric oncology nutrition program: Lessons learnt over a decade. [2022]