Medically tailored frozen meals for children with cancer
Feasibility of Medically Tailored Meals for Pediatric Populations at Risk for Disparities in Serious Illness Outcomes Due to Inequities in Social Drivers of Health (MTM-Kids)
NA · UNC Lineberger Comprehensive Cancer Center · NCT06814795
This project will try providing home-delivered, medically tailored frozen meals for 12 weeks to children aged 12–17.9 receiving chemotherapy and their primary parent caregivers to see if the approach is feasible and acceptable.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 30 (estimated) |
| Ages | 12 Years to 99 Years |
| Sex | All |
| Sponsor | UNC Lineberger Comprehensive Cancer Center (other) |
| Drugs / interventions | chemotherapy, immunotherapy |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06814795 on ClinicalTrials.gov |
What this trial studies
This is a small feasibility pilot that will deliver home-prepared, medically tailored frozen meals for 12 weeks to pediatric oncology patients and their primary parental caregivers. Eligible children are 12–17.9 years old, treated in the UNC Chapel Hill pediatric hematology/oncology clinic, who have completed at least one chemotherapy cycle known to alter taste and expect at least two more cycles. The study enrolls 15 child–caregiver pairs and measures feasibility and acceptability outcomes, with materials and communications available in English and Spanish. The intervention targets food and nutrition insecurity as actionable social drivers of health during active cancer treatment.
Who should consider this trial
Good fit: Ideal candidates are children aged 12–17.9 receiving care in the UNC pediatric hematology/oncology clinic who have had at least one taste-altering chemotherapy cycle and expect at least two more, together with their primary parental caregiver aged 18 or older who speaks English or Spanish.
Not a fit: Children who are outside the age range, are not receiving the specified chemotherapy regimens, live outside the meal delivery area, or are not experiencing food or nutrition insecurity are unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, this approach could improve nutrition, reduce food insecurity, and help children better tolerate treatment and maintain quality of life during therapy.
How similar studies have performed: Medically tailored meals have shown benefits in adult populations with chronic illness and food insecurity, but applying this specific approach to pediatric oncology patients is largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Eligible children (n=15) 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 * have completed at least one cycle of cancer chemotherapy that included an agent known to cause alterations in taste, * expect to undergo at least two more cycles, * be aged 12-17.9 years * communicate in English or Spanish. Eligible adults (n=15) will: * be the primary parental caregiver of a study-eligible child, * be aged 18 years or older * communicate in English or Spanish. Exclusion Criteria: * none if inclusion criteria are met
Where this trial is running
Chapel Hill, North Carolina
- North Carolina Basnight Cancer Hospital — Chapel Hill, North Carolina, United States (RECRUITING)
Study contacts
- Principal investigator: Sheila J. Santacroce — University of North Carolina, Chapel Hill
- Study coordinator: Sheila J. Santacroce, PhD
- Email: sheila.santacroce@unc.edu
- Phone: (984) 974-0000
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Pediatric Cancer, chemotherapy-induced alterations in taste, Food insecurity, Nutrition insecurity, Household material hardship, Resource hardship, Social drivers of health disparities