An interventional study of Medically Tailored Meals and Caregiver Coaching in Pediatric Cancer, Malnutrition, Child and Caregiver Burden, sponsored by Drexel University. Not yet recruiting at 1 site in United States. Open to participants aged 5 Years to 21 Years. Per ClinicalTrials.gov, last updated 2026-03-09.
Sponsored by Drexel University · Not applicable, Interventional, and Supportive 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.
10,818 studies on the registry are indexed under Neoplasms; 2,324 are open to participants now.
This study's planned enrollment of 120 is above the median of 60 across 7,703 interventional studies indexed under Neoplasms.
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
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
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.
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.
Recruitment feasibility
Participants enrolled per month of recruitment
Time frame: 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.
Time frame: 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 (%)
Time frame: Weeks 1 - 12 (intervention period)
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 weeks
Assessment feasibility
Proportion of retained participants who provide valid data for each assessment task
Time frame: From baseline to 12 months.
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 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.
Time frame: 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.
Time frame: 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".
Time frame: 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).
Time frame: 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).
Time frame: 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.
Time frame: 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".
Time frame: baseline, 3, 6 and 12 months
Plan to share: No — IPD available upon reasonable request to PI
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