Ignite Creation Date:
2026-03-26 @ 3:20 PM
Ignite Modification Date:
2026-03-31 @ 11:50 AM
Study NCT ID:
NCT07454902
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-03-09
First Post:
2026-01-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
From Kitchen to Clinic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D015362', 'term': 'Child Nutrition Disorders'}, {'id': 'D000084802', 'term': 'Caregiver Burden'}], 'ancestors': [{'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2028-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-05', 'studyFirstSubmitDate': '2026-01-21', 'studyFirstSubmitQcDate': '2026-03-02', 'lastUpdatePostDateStruct': {'date': '2026-03-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Recruitment feasibility', 'timeFrame': 'Up to one year', 'description': 'Participants enrolled per month of recruitment'}, {'measure': 'Intervention Acceptability', 'timeFrame': '12 weeks (end of intervention)', 'description': '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.'}, {'measure': 'Treatment adherence', 'timeFrame': 'Weeks 1 - 12 (intervention period)', 'description': 'Caregiver coaching adherence (dose received): Attendance rate\n\nChild and family meals consumed will be assessed using three complementary sources:\n\n1. Weekly 3-item caregiver survey\n2. Coaching call confirmation\n3. Dietary recall cross-check\n\nThe previous three sources will be used to calculate and confirm: % of provided child meals consumed ;% of family meals consumed\n\nA composite adherence score will be calculated: (0-100 index each week; averaged across weeks)\n\nWeekly Adherence Index = 0.50 × Child MTM uptake (%)\n\n* 0.20 × Family MTM uptake (%)\n* 0.30 × Coaching session completion (%)'}, {'measure': 'Retention feasibility', 'timeFrame': 'From enrollment until the end of treatment at 12 weeks', 'description': 'Percent of participants providing assessment data at 12 weeks (end of treatment)'}, {'measure': 'Assessment feasibility', 'timeFrame': 'From baseline to 12 months.', 'description': 'Proportion of retained participants who provide valid data for each assessment task'}], 'secondaryOutcomes': [{'measure': 'Change in patient dietary intake', 'timeFrame': 'Baseline, 3, 6 and 12 months', 'description': '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.'}, {'measure': 'Change in patient body mass index', 'timeFrame': 'Baseline, 3, 6 and 12 months', 'description': '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.'}, {'measure': 'Household food security', 'timeFrame': 'Baseline, 3, 6 and 12 months', 'description': '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.'}, {'measure': 'Household nutrition security', 'timeFrame': 'Baseline, 3, 6 and 12 months', 'description': '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".'}, {'measure': 'Caregiver emotional distress - anxiety', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': '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).'}, {'measure': 'Caregiver satisfaction with social roles and activities', 'timeFrame': 'Baseline, 3 months, 6 months, and 12 months', 'description': "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)."}, {'measure': 'Change in patient mid-upper arm circumference', 'timeFrame': 'baseline, 3, 6- and 12 months', 'description': 'Mid-upper arm circumference (MUAC) will be measured using a soft measuring tape.'}, {'measure': 'Household Healthfulness Choices Security', 'timeFrame': 'baseline, 3, 6 and 12 months', 'description': '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".'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pediatric oncology', 'Nutrition intervention', 'Medically tailored meals', 'Feasibility studies', 'Caregivers'], 'conditions': ['Pediatric Cancer', 'Malnutrition, Child', 'Caregiver Burden']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '21 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Patient Inclusion Criteria:\n\n1. Receiving cancer treatment for any cancer diagnosis\n2. 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\n3. At least 5-21 years of age at the time of enrollment\n4. English-speaking\n5. Approved to participate by both their oncologist and RDN\n6. Must anticipate to live in the same household as the designated caregiver for the duration of the study\n\nPatient Exclusion Criteria:\n\n1. Experiencing swallowing or digestive diseases/food allergies (e.g. celiacs, lactose intolerance, nut allergy), or specific food preferences that cannot be accommodated by MANNA.\n2. Receiving nutrition via nasogastric or gastric tube feedings\n3. Bone marrow transplant patient'}, 'identificationModule': {'nctId': 'NCT07454902', 'briefTitle': 'From Kitchen to Clinic', 'organization': {'class': 'OTHER', 'fullName': 'Drexel University'}, 'officialTitle': 'From Kitchen to Clinic: A Family-Centered, Food-As-Medicine Approach Using Medically Tailored Meals and Caregiver Coaching in Pediatric Oncology Care', 'orgStudyIdInfo': {'id': '25SC051'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Medically tailored meals and caregiver coaching', 'description': "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).", 'interventionNames': ['Other: Medically Tailored Meals', 'Behavioral: Caregiver Coaching']}], 'interventions': [{'name': 'Medically Tailored Meals', 'type': 'OTHER', 'description': '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.', 'armGroupLabels': ['Medically tailored meals and caregiver coaching']}, {'name': 'Caregiver Coaching', 'type': 'BEHAVIORAL', 'description': '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.', 'armGroupLabels': ['Medically tailored meals and caregiver coaching']}]}, 'contactsLocationsModule': {'locations': [{'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'IPD available upon reasonable request to PI'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Drexel University', 'class': 'OTHER'}, 'collaborators': [{'name': "Children's Hospital of Philadelphia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}