From Kitchen to Clinic
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age5-21
SponsorDrexel University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Medically Tailored Meals
Other interventionThe 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 Coaching
BehavioralFor 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.
Treatment groups
120 Participants
are divided into 1 treatment groupGroup A: Medically tailored meals and caregiver coachingExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Recruitment feasibility
Participants enrolled per month of recruitment
Time frame
Up to one year2
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.
Time frame
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 (%)
Time frame
Weeks 1 - 12 (intervention period)4
Retention feasibility
Percent of participants providing assessment data at 12 weeks (end of treatment)
Time frame
From enrollment until the end of treatment at 12 weeksSecondary outcomes
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.
Time frame
Baseline, 3, 6 and 12 months2
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.
Time frame
Baseline, 3, 6 and 12 months3
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.
Time frame
Baseline, 3, 6 and 12 months4
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".
Time frame
Baseline, 3, 6 and 12 monthsSponsors and contacts
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Drexel University
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Source ClinicalTrials.gov
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