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Not yet recruiting NCT07454902

From Kitchen to Clinic

No phase Interventional Pediatric Cancer Malnutrition, Child Caregiver Burden

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Medically Tailored Meals, Caregiver Coaching.
Who it may be relevant to
Registry conditions: Pediatric Cancer, Malnutrition, Child, Caregiver Burden. Basic parameters: 5 years — 21 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • 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.

Primary outcome measures

  • Recruitment feasibility [Time frame: Up to one year]
  • Intervention Acceptability [Time frame: 12 weeks (end of intervention)]
  • Treatment adherence [Time frame: Weeks 1 - 12 (intervention period)]
  • Retention feasibility [Time frame: From enrollment until the end of treatment at 12 weeks]
  • Assessment feasibility [Time frame: From baseline to 12 months.]
Secondary outcome measures (8)
  • Change in patient dietary intake [Time frame: Baseline, 3, 6 and 12 months]
  • Change in patient body mass index [Time frame: Baseline, 3, 6 and 12 months]
  • Household food security [Time frame: Baseline, 3, 6 and 12 months]
  • Household nutrition security [Time frame: Baseline, 3, 6 and 12 months]
  • Caregiver emotional distress - anxiety [Time frame: Baseline, 3 months, 6 months, and 12 months]
  • Caregiver satisfaction with social roles and activities [Time frame: Baseline, 3 months, 6 months, and 12 months]
  • Change in patient mid-upper arm circumference [Time frame: baseline, 3, 6- and 12 months]
  • Household Healthfulness Choices Security [Time frame: baseline, 3, 6 and 12 months]

Eligibility criteria

Patient Inclusion Criteria:

  • 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

Patient Exclusion Criteria:

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Supportive care

Study locations

United States · 1 center
  • Children's Hospital of Philadelphia — Philadelphia

Identifiers

NCT: NCT07454902 · 25SC051

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗