From Kitchen to Clinic: A Family-Centered, Food-As-Medicine Approach Using Medically Tailored Meals and Caregiver Coaching in Pediatric Oncology Care
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Recruitment feasibility
研究概览
简要总结
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.
详细描述
Children undergoing cancer treatment are at high risk for nutrition-related complications, including inadequate nutrient intake, weight loss, excess weight gain, and disruptions in normal growth patterns. These challenges are driven by treatment-related side effects such as nausea, vomiting, taste changes, fatigue, and reduced physical activity, as well as by the substantial caregiving burden placed on families during active treatment. Caregivers are often responsible for managing complex dietary needs while balancing medical appointments, emotional stress, and competing household demands, which can negatively affect dietary quality, household nutrition security, and caregiver well-being. Poor dietary patterns established during treatment may persist into survivorship, increasing long-term cardiometabolic risk for children with cancer.
Food-as-medicine interventions, particularly medically tailored meals (MTMs), represent a promising strategy to address both clinical and social drivers of nutrition-related risk. MTMs provide nutritionally appropriate, ready-to-eat meals designed to align with specific medical needs, thereby reducing caregiver burden and supporting treatment goals. While MTMs have demonstrated benefits in adult populations with serious illness, including improved nutrition and reduced healthcare utilization, their feasibility and acceptability in pediatric oncology care have not been well studied.
This pilot study, From Kitchen to Clinic, is a prospective, single-arm clinical trial designed to evaluate the feasibility and acceptability of a 12-week, family-centered food-as-medicine intervention for children undergoing active cancer treatment and their caregivers. The intervention combines weekly delivery of medically tailored meals prepared by the Metropolitan Area Neighborhood Nutrition Alliance (MANNA) with individualized caregiver coaching provided by registered dietitian nutritionists (RDNs). The study will enroll up to 60 pediatric oncology patients and their caregivers at the Children's Hospital of Philadelphia.
The intervention is delivered in two phases. During weeks 1-8, families receive comprehensive support, including weekly delivery of 21 child-friendly MTMs plus snacks for the pediatric patient and 7 meals per week for the family, along with weekly one-on-one caregiver coaching sessions. Coaching sessions focus on practical nutrition strategies, symptom management, meal integration into family routines, and building caregiver confidence in supporting their child's nutritional needs during treatment. During weeks 9-12, support is tapered to promote sustainability and caregiver autonomy. Meal delivery is reduced to 7 meals per week for the patient while family meal support continues, and coaching sessions shift to a bi-weekly schedule.
The primary outcomes of the study are feasibility and acceptability. Secondary, exploratory outcomes will examine preliminary changes in patient dietary intake and dietary quality, weight and growth trajectories, and treatment tolerance, as well as changes in household nutrition security and caregiver burden and distress. Data will be collected at baseline and at 3-, 6-, and 12-month follow-up timepoints using a combination of medical record review, anthropometric measurements, caregiver-reported questionnaires, and dietary recalls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 5 Years 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient Inclusion Criteria:
- •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
- •Approved to participate by both their oncologist and RDN
- •Must anticipate to live in the same household as the designated caregiver for the duration of the study
排除标准
- •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
研究组 & 干预措施
Medically tailored meals and caregiver coaching
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).
干预措施: Medically Tailored Meals (Other)
Medically tailored meals and caregiver coaching
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).
干预措施: Caregiver Coaching (Behavioral)
结局指标
主要结局
Recruitment feasibility
时间窗: Up to one year
Participants enrolled per month of recruitment
Treatment adherence
时间窗: Weeks 1 - 12 (intervention period)
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 (%)
Retention feasibility
时间窗: From enrollment until the end of treatment at 12 weeks
Percent of participants providing assessment data at 12 weeks (end of treatment)
Assessment feasibility
时间窗: From baseline to 12 months.
Proportion of retained participants who provide valid data for each assessment task
Intervention Acceptability
时间窗: 12 weeks (end of intervention)
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.
次要结局
- Change in patient dietary intake(Baseline, 3, 6 and 12 months)
- Change in patient body mass index(Baseline, 3, 6 and 12 months)
- Household food security(Baseline, 3, 6 and 12 months)
- Caregiver emotional distress - anxiety(Baseline, 3 months, 6 months, and 12 months)
- Caregiver satisfaction with social roles and activities(Baseline, 3 months, 6 months, and 12 months)
- Change in patient mid-upper arm circumference(baseline, 3, 6- and 12 months)
- Household Healthfulness Choices Security(baseline, 3, 6 and 12 months)
- Household nutrition security(Baseline, 3, 6 and 12 months)