From Kitchen to Clinic

NCT07454902 | Not Yet Recruiting

• 1 other identifier: 25SC051
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Children receiving cancer treatment often experience nutrition-related challenges, such as changes in appetite, weight, and food intake, due to treatment side effects and the demands placed on families during care. These challenges can increase caregiver stress, reduce diet quality, and contribute to short- and long-term health risks for children. While medically tailored meals have been shown to improve nutrition and reduce burden in adults with serious illness, their use in pediatric cancer care has not been well studied. This pilot study will evaluate the feasibility and acceptability of a 12-week, family-centered food-as-medicine program for children undergoing active cancer treatment and their caregivers. The program combines weekly delivery of medically tailored meals with individualized caregiver coaching provided by registered dietitian nutritionists. During the first eight weeks, families receive full meal support and weekly coaching sessions, followed by a four-week transition period with tapered meal delivery and bi-weekly coaching to support sustainable nutrition practices. A total of 60 pediatric patients and their caregivers will be enrolled at the Children's Hospital of Philadelphia. The study will assess whether families can be successfully recruited and retained, whether they are able to participate in study activities, and whether the program is acceptable and usable during cancer treatment. The study will also explore preliminary effects on children's dietary intake, weight and growth patterns, treatment tolerance, household nutrition security, and caregiver stress and burden.

Conditions

Pediatric Cancer; Malnutrition, Child; Caregiver Burden

Keywords

Pediatric oncology; Nutrition intervention; Medically tailored meals; Feasibility studies; Caregivers

Outcome Measures

Primary Outcomes (5)

• Recruitment feasibility

  Participants enrolled per month of recruitment

  Up to one year

• Intervention Acceptability

  Acceptability of the medically tailored meals and caregiver coaching program will be assessed using caregiver-focused questions developed by the investigators. Acceptability domains include overall program acceptability, acceptability of medically tailored meals, acceptability of caregiver coaching, and integration of the intervention into family routines. Responses are measured using a 5-point Likert scale, with higher scores indicating greater acceptability.

  12 weeks (end of intervention)

• Treatment adherence

  Caregiver coaching adherence (dose received): Attendance rate Child and family meals consumed will be assessed using three complementary sources: 1. Weekly 3-item caregiver survey 2. Coaching call confirmation 3. Dietary recall cross-check The previous three sources will be used to calculate and confirm: % of provided child meals consumed ;% of family meals consumed A composite adherence score will be calculated: (0-100 index each week; averaged across weeks) Weekly Adherence Index = 0.50 × Child MTM uptake (%) * 0.20 × Family MTM uptake (%) * 0.30 × Coaching session completion (%)

  Weeks 1 - 12 (intervention period)

• Retention feasibility

  Percent of participants providing assessment data at 12 weeks (end of treatment)

  From enrollment until the end of treatment at 12 weeks

• Assessment feasibility

  Proportion of retained participants who provide valid data for each assessment task

  From baseline to 12 months.

Secondary Outcomes (8)

• Change in patient dietary intake

  Baseline, 3, 6 and 12 months

• Change in patient body mass index

  Baseline, 3, 6 and 12 months

• Household food security

  Baseline, 3, 6 and 12 months

• Household nutrition security

  Baseline, 3, 6 and 12 months

• Caregiver emotional distress - anxiety

  Baseline, 3 months, 6 months, and 12 months

Study Arms (1)

Medically tailored meals and caregiver coaching

EXPERIMENTAL

This pilot study is a single-arm clinical trial. Sixty pediatric oncology patients and their caregivers (N=120) will be enrolled at the Children's Hospital of Philadelphia (Buerger and KOP locations).

Other: Medically Tailored Meals; Behavioral: Caregiver Coaching

Interventions

Medically Tailored Meals OTHER

The total length of the intervention is 12 weeks. For 8 weeks, participants will receive weekly deliveries of 21 child-friendly MTMs plus snacks for the patient and 7 meals for the family, alongside weekly caregiver coaching sessions. In weeks 9-12, MTMs will taper to 1 meal/day for the patient, family meal support will continue, and coaching will shift to bi-weekly sessions.

Medically tailored meals and caregiver coaching

Caregiver Coaching BEHAVIORAL

For 8 weeks, participants will receive weekly deliveries of 21 child-friendly MTMs plus snacks for the patient and 7 meals for the family, alongside weekly caregiver coaching sessions. In weeks 9-12, MTMs will taper to 1 meal/day for the patient, family meal support will continue, and coaching will shift to bi-weekly sessions.

Medically tailored meals and caregiver coaching

Eligibility Criteria

• Age: 5 Years - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Receiving cancer treatment for any cancer diagnosis
• Within the first 3-6 weeks of diagnosis i. Diagnosis date is defined as the date of the family meeting relaying diagnosis to the patient/caregiver/family
• At least 5-21 years of age at the time of enrollment
• English-speaking
• Approved to participate by both their oncologist and RDN
• Must anticipate to live in the same household as the designated caregiver for the duration of the study

You may not qualify if:

• Experiencing swallowing or digestive diseases/food allergies (e.g. celiacs, lactose intolerance, nut allergy), or specific food preferences that cannot be accommodated by MANNA.
• Receiving nutrition via nasogastric or gastric tube feedings
• Bone marrow transplant patient

Sponsors & Collaborators

• Drexel University: lead
• Children's Hospital of Philadelphia: collaborator

Study Sites (1)

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Neoplasms; Child Nutrition Disorders; Caregiver Burden

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Stress, Psychological; Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single-arm, prospective, non-randomized interventional model in which all enrolled pediatric oncology patients and their caregivers receive a 12-week, family-centered food-as-medicine intervention combining medically tailored meal delivery and caregiver coaching, followed by observational follow-up to assess feasibility, acceptability, and exploratory outcomes.

Study Record Dates

• First Submitted: January 21, 2026
• First Posted: March 6, 2026
• Study Start: March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: March 9, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)