From Kitchen to Clinic

From Kitchen to Clinic: A Family-Centered, Food-As-Medicine Approach Using Medically Tailored Meals and Caregiver Coaching in Pediatric Oncology Care

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caregiver Burden; Pediatric Cancer; Malnutrition, Child
• Intervention / Treatment: Other: Medically Tailored Meals; Behavioral: Caregiver Coaching

Detailed Description

Children undergoing cancer treatment are at high risk for nutrition-related complications, including inadequate nutrient intake, weight loss, excess weight gain, and disruptions in normal growth patterns. These challenges are driven by treatment-related side effects such as nausea, vomiting, taste changes, fatigue, and reduced physical activity, as well as by the substantial caregiving burden placed on families during active treatment. Caregivers are often responsible for managing complex dietary needs while balancing medical appointments, emotional stress, and competing household demands, which can negatively affect dietary quality, household nutrition security, and caregiver well-being. Poor dietary patterns established during treatment may persist into survivorship, increasing long-term cardiometabolic risk for children with cancer.

Food-as-medicine interventions, particularly medically tailored meals (MTMs), represent a promising strategy to address both clinical and social drivers of nutrition-related risk. MTMs provide nutritionally appropriate, ready-to-eat meals designed to align with specific medical needs, thereby reducing caregiver burden and supporting treatment goals. While MTMs have demonstrated benefits in adult populations with serious illness, including improved nutrition and reduced healthcare utilization, their feasibility and acceptability in pediatric oncology care have not been well studied.

This pilot study, From Kitchen to Clinic, is a prospective, single-arm clinical trial designed to evaluate the feasibility and acceptability of a 12-week, family-centered food-as-medicine intervention for children undergoing active cancer treatment and their caregivers. The intervention combines weekly delivery of medically tailored meals prepared by the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) with individualized caregiver coaching provided by registered dietitian nutritionists (RDNs). The study will enroll up to 60 pediatric oncology patients and their caregivers at the Children's Hospital of Philadelphia.

The intervention is delivered in two phases. During weeks 1-8, families receive comprehensive support, including weekly delivery of 21 child-friendly MTMs plus snacks for the pediatric patient and 7 meals per week for the family, along with weekly one-on-one caregiver coaching sessions. Coaching sessions focus on practical nutrition strategies, symptom management, meal integration into family routines, and building caregiver confidence in supporting their child's nutritional needs during treatment. During weeks 9-12, support is tapered to promote sustainability and caregiver autonomy. Meal delivery is reduced to 7 meals per week for the patient while family meal support continues, and coaching sessions shift to a bi-weekly schedule.

The primary outcomes of the study are feasibility and acceptability. Secondary, exploratory outcomes will examine preliminary changes in patient dietary intake and dietary quality, weight and growth trajectories, and treatment tolerance, as well as changes in household nutrition security and caregiver burden and distress. Data will be collected at baseline and at 3-, 6-, and 12-month follow-up timepoints using a combination of medical record review, anthropometric measurements, caregiver-reported questionnaires, and dietary recalls.

This study is designed to generate critical pilot data on the practicality of integrating a food-as-medicine approach into pediatric oncology care. Findings will inform whether this combined MTM and caregiver coaching intervention is feasible, acceptable, and appropriate for further testing in a larger, controlled trial. Ultimately, this work aims to support scalable, family-centered nutrition interventions that improve both clinical outcomes and quality of life for children with cancer and their caregivers.

• Study Type: Interventional
• Enrollment (Estimated): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • Children's Hospital of Philadelphia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Patient Inclusion Criteria:

1. Receiving cancer treatment for any cancer diagnosis
2. 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
3. At least 5-21 years of age at the time of enrollment
4. English-speaking
5. Approved to participate by both their oncologist and RDN
6. Must anticipate to live in the same household as the designated caregiver for the duration of the study

Patient Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Medically tailored meals and caregiver coaching; 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; 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.; Behavioral: Caregiver Coaching; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment feasibility	Participants enrolled per month of recruitment	Up to one year
Treatment adherence	Caregiver coaching adherence (dose received): Attendance rate Child and family meals consumed will be assessed using three complementary sources: Weekly 3-item caregiver survey; Coaching call confirmation; 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.
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)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in patient dietary intake	Child dietary intake will be assessed using caregiver proxy reports via the Automated Self-Administered 24-hour Dietary Recall (ASA24). Measures include total energy intake, macronutrients, micronutrients, and dietary patterns.	Baseline, 3, 6 and 12 months
Change in patient body mass index	Weight and height will be used to calculate body mass index (BMI) z-score for children under 18 years old and BMI for participants 18-21 years old. Weight (in kilograms) and height (in meters) will be combined to report BMI in kg/m^2.	Baseline, 3, 6 and 12 months
Household food security	Household food security will be assessed using the two-item Hunger Vital Signs screener, which asks caregivers about food availability at home. Responses are reported anchored by the words "Often true", "Sometimes true", and "Never true". The measure captures perceived availability and adequacy of food in the household.	Baseline, 3, 6 and 12 months
Caregiver emotional distress - anxiety	Emotional distress-anxiety will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety Short Form, a validated patient-reported instrument that evaluates the frequency and severity of anxiety symptoms over the prior 7 days and has been widely used in clinical and oncology populations. PROMIS measures have been rigorously validated across diverse populations and use T-scores standardized to the U.S. general population (mean = 50, SD = 10), enabling comparability across studies. Raw scores range from 8-40. Higher scores indicate greater anxiety symptoms (worse outcome).	Baseline, 3 months, 6 months, and 12 months
Caregiver satisfaction with social roles and activities	Satisfaction with social roles and activities will be assessed using the Patient-Reported Outcomes Measurement Information System (PROMIS) Satisfaction with Social Roles and Activities Short Form, a validated patient-reported measure that assesses individuals' perceived satisfaction with their ability to participate in social, family, and work-related roles and activities over the prior 7 days. Raw scores range from 8-40. Higher scores indicate greater satisfaction with social roles (better outcome).	Baseline, 3 months, 6 months, and 12 months
Change in patient mid-upper arm circumference	Mid-upper arm circumference (MUAC) will be measured using a soft measuring tape.	baseline, 3, 6- and 12 months
Household Healthfulness Choices Security	Caregivers report the nutritional value of food at home. Responses are reported anchored by the words "Never", "Rarely", "Sometimes", "Often", "Always", and "Don't know". The Healthfulness Choices survey will be assessed using adapted survey instruments developed by Calloway and colleagues (Appetite 2022). In this study, items and response options were unchanged; only the recall period was shorted to 'past 3 months".	baseline, 3, 6 and 12 months
Household nutrition security	Caregivers are asked about food consumption and overall wellbeing. Responses are reported anchored by the words "Never", "Rarely", "Sometimes", "Often", "Always", and "Don't know". The Nutrition Security survey will be assessed using adapted survey instruments developed by Calloway and colleagues. In this study, items and response options were unchanged; only the recall period was shorted to 'past 3 months".	Baseline, 3, 6 and 12 months

Collaborators and Investigators

• Sponsor: Drexel University
• Collaborators: Children's Hospital of Philadelphia

Study record dates

Study Major Dates

• Study Start (Estimated): March 1, 2026
• Primary Completion (Estimated): September 1, 2028
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: January 21, 2026
• First Submitted That Met QC Criteria: March 2, 2026
• First Posted (Actual): March 6, 2026

Study Record Updates

• Last Update Posted (Actual): March 9, 2026
• Last Update Submitted That Met QC Criteria: March 5, 2026
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Caregivers; Pediatric oncology; Nutrition intervention; Feasibility studies; Medically tailored meals
• Additional Relevant MeSH Terms: Nutrition Disorders; Behavioral Symptoms; Stress, Psychological; Behavior; Nutritional and Metabolic Diseases; Caregiver Burden; Neoplasms; Child Nutrition Disorders
• Other Study ID Numbers: 25SC051

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: IPD available upon reasonable request to PI

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No