Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Children's Hospital of Philadelphia | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medically tailored meals and caregiver coaching | Experimental | 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Medically Tailored Meals | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment feasibility | Participants enrolled per month of recruitment | 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. | 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:
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 (%)
| 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. |
| 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 |
Not provided
Patient Inclusion Criteria:
Patient Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | United States |
IPD available upon reasonable request to PI
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D015362 | Child Nutrition Disorders |
| D000084802 | Caregiver Burden |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D013315 | Stress, Psychological |
| D001526 | Behavioral Symptoms |
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
|
| Caregiver Coaching | Behavioral | 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. |
|
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 |
| 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 |
| 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 |
| D001519 | Behavior |