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Pediatric CancerNCT07454902

From Kitchen to Clinic

A study testing Medically Tailored Meals and Caregiver Coaching in people with Pediatric Cancer and Malnutrition, Child, run by Drexel University at 1 site in United States.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 5 to 21 years
What is being tested?
Medically Tailored Meals and Caregiver Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
1 siteUnited States
Study dates
Mar 2026to Dec 2028
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 5 to 21 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvania, 19104

Other trials in United States

About this study

Official title: 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.

Being tested
Medically Tailored Meals, Caregiver Coaching
Keywords
Pediatric oncology, Nutrition intervention, Medically tailored meals, Feasibility studies, Caregivers
Medical subject headings
Neoplasms, Child Nutrition Disorders, Caregiver Burden

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Medically Tailored MealsOther

    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.

  • Caregiver CoachingBehavioural

    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.

Study groups in NCT07454902
Study groupRoleWhat they receive
Medically tailored meals and caregiver coachingExperimentalThis 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).
Receives: Other: Medically Tailored Meals; Behavioral: Caregiver Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Recruitment feasibility

    Participants enrolled per month of recruitment

    Measured: Up to one year

  2. 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.

    Measured: 12 weeks (end of intervention)

  3. 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 (%)

    Measured: Weeks 1 - 12 (intervention period)

  4. Retention feasibility

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

    Measured: From enrollment until the end of treatment at 12 weeks

  5. Assessment feasibility

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

    Measured: From baseline to 12 months.

Secondary outcomes (8)

  1. 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.

    Measured: Baseline, 3, 6 and 12 months

  2. 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.

    Measured: Baseline, 3, 6 and 12 months

  3. 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.

    Measured: Baseline, 3, 6 and 12 months

  4. 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".

    Measured: Baseline, 3, 6 and 12 months

  5. 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).

    Measured: Baseline, 3 months, 6 months, and 12 months

  6. 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).

    Measured: Baseline, 3 months, 6 months, and 12 months

  7. Change in patient mid-upper arm circumference

    Mid-upper arm circumference (MUAC) will be measured using a soft measuring tape.

    Measured: baseline, 3, 6- and 12 months

  8. 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".

    Measured: baseline, 3, 6 and 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Mar 2026
  2. Study startMar 2026 (estimated)
  3. Primary completionSep 2028 (estimated)
  4. Study completionDec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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.
Masking
None (open label)
Enrolment
120 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07454902
Sponsor's protocol ID
25SC051
Status last verified
Dec 2025
First submitted
21 Jan 2026
Last updated
9 Mar 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: IPD available upon reasonable request to PI

Publications

  • Milliron BJ, Schlechter H, Muir C, Moss C, Henstenburg JA, Rappaport K, Boakye F, Deutsch JM, Jubelirer T. From Kitchen to Clinic: Study protocol for a family-centered, food-as-medicine approach using medically tailored meals and caregiver coaching in pediatric oncology care. Contemp Clin Trials Commun. 2026 Aug 29;53:101681. doi: 10.1016/j.conctc.2026.101681. eCollection 2026 Oct.

    PubMed 42729466

Questions about this trial

What is this clinical trial studying?

A study testing Medically Tailored Meals and Caregiver Coaching in people with Pediatric Cancer and Malnutrition, Child, run by Drexel University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 9 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Recruitment feasibility (time frame: Up to one year). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07454902, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2026.

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