Clinical trial NCT06523322: Culinary Medicine for Cancer Caregivers
Official title: Culinary Medicine for Caregivers: Improving Pediatric Cancer Patient and Caregiver Outcomes Through Nutrition and Culinary Support
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Pediatric Cancer
Caregiver Burden
Cancer, Treatment-Related
Nutrition Aspect of Cancer
Keywords: Culinary medicine
Nutrition
Cancer caregiver
Lead sponsor: Drexel University
Sponsor class: OTHER
Collaborators: name: Children's Hospital of Philadelphia
First posted: 2024-07-26
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: The 8-week Let's Cook Together program is intended to increase: caregiver knowledge of the benefits of a whole foods approach to eating; preparedness for caregiving; and caregiver self-efficacy for managing patients' nutrition-related side effects. The entire program will be delivered remotely. Caregivers will be recruited to participate in an 8-week remote culinary medicine intervention, including four remote synchronous culinary workshops (one 90-minute introductory event and three, 90-minute culinary/cooking sessions), and four bi-weekly caregiver coaching telephone calls (lasting 15-20 minutes).
Primary purpose: SUPPORTIVE_CARE

Brief summary: Pediatric cancer and the therapies used in treatment can affect nutritional status, which can impact treatment tolerance, survival, and overall well-being. Poorly managed side effects can lead to long-term poor dietary habits. Caregivers who endure the psychosocial toll of these effects, also face risks to their own well-being. Prioritizing interventions that enhance caregivers' ability to provide quality care and improve long-term health is crucial. The primary aim of this study is to determine the feasibility and acceptability of an 8-week culinary medicine intervention with caregiver coaching for caregivers of children undergoing cancer treatment. The secondary aim is to estimate the effect of the intervention on caregiving preparedness, caregiver self-confidence for managing patient treatment side effects, eating-related distress, and dietary intake. In-depth interviews will explore participant experiences and perspectives on the feasibility and acceptability of the culinary nutrition program, and to inform interpretation of findings and future program refinement.

Detailed description: Pediatric cancer and the therapies used in treatment can affect nutritional status, which can then impact treatment tolerance, survival, and overall well-being. Poorly managed side effects can lead to long-term poor dietary habits. Caregivers who endure the psychosocial toll of these effects, also face risks to their own well-being. Prioritizing interventions that enhance caregivers' ability to provide quality care and improve long-term health is crucial. Culinary medicine interventions have demonstrated efficacy in boosting cooking confidence and dietary quality as well as providing positive benefits to help with cancer treatment side effects. The investigators developed an 8-week culinary nutrition program incorporating caregiver coaching to enhance outcomes for pediatric cancer patients and their caregivers. Let's Cook Together aims to increase caregiver knowledge of a whole foods approach to eating, enhance preparedness for caregiving, and boost caregiver self-efficacy for managing side effects. Caregivers with children undergoing cancer treatment will be recruited from the Children's Hospital of Philadelphia. The program includes four remote cooking sessions led by a Medical Chef Educator and a Registered Dietitian Nutritionist, and bi-weekly coaching sessions to discuss caregiving goals, challenges, and problem-solving strategies. Written resources including nutrition education and recipes will be provided to all study participants. A single-arm mixed-methods feasibility study will assess the program's viability. Participants will undergo assessments at baseline, post-intervention, and three months post-intervention, with qualitative interviews post-intervention. The primary goal is to evaluate feasibility and acceptability, while secondary objectives include assessing preliminary efficacy on caregiving preparedness, caregiver self-efficacy, pediatric feeding behaviors, and dietary intake/behaviors. Results from the feasibility pilot, including qualitative feedback, will be used to guide the interpretation of findings, refine the study methodology and Let's Cook Together program, and inform the design of an adequately powered definitive trial. Findings may be of interest to a broad range of oncology and allied health professionals engaged in supportive care for families experiencing cancer treatment.

Eligibility criteria: \*Please note the above age limit and 'accepts health volunteers' specifications are related to the caregiver as the participant. Additional age limit criteria for patient is listed below. All caregivers will be providing care for a child undergoing current cancer treatment.

Inclusion Criteria, Patient:

* Receiving active cancer treatment for a liquid or solid cancer diagnosis
* At least 4-17 years of age
* English-speaking
* Taking \>50% intake orally
* Approved to participate by both their oncologist and registered dietitian nutritionist

Exclusion Criteria, Patient:

* Undergoing bone marrow transplantation
* Receiving active cancer treatment for a brain tumor

Inclusion Criteria, Caregiver:

* Caregiver (parent or legal guardian) of a child who meets the inclusion and exclusion criteria for patients, above
* Can read and speak English
* Has access to a computer (i.e., tablet, laptop, desktop computer) and internet
* Is at least 18 years of age
* Has the ability to provide informed consent

Primary outcomes:
measure: Feasibility of the intervention as assessed by participant session attendance, assessment completion, and participant retention.
timeFrame: During the intervention; immediately after the intervention; and 3-months after the intervention
measure: Acceptability of the intervention as assessed by comprehension of intervention content, personal relevance, and appropriate information volume.
timeFrame: During the intervention; immediately after the intervention; and 3-months after the intervention
measure: Usage of the intervention as assessed by the number of recipes used.
timeFrame: During the intervention; immediately after the intervention; and 3-months after the intervention
measure: Usability of the intervention as assessed by ease of use and plan for continued use.
timeFrame: During the intervention; immediately after the intervention; and 3-months after the intervention
measure: Perceived usefulness as assessed by the extent to which the session was useful in helping participants to increase their confidence, overcome barriers, and increase the support they receive.
timeFrame: During the intervention; immediately after the intervention; and 3-months after the intervention
Secondary outcomes:
measure: Change from baseline in preparedness for caregiving as assessed by the Preparedness for Caregiving Scale.
timeFrame: Baseline; immediately after the intervention; and 3-months after the intervention
measure: Change from baseline in caregiver self-efficacy to manage treatment-related side effects a assessed by the Caregiver Self-Efficacy for Management of Treatment Side Effects survey
timeFrame: Baseline; immediately after the intervention; and 3-months after the intervention
measure: Change from baseline in caregiver eating-related distress as assessed by the Behavioral Pediatrics Feeding Assessment Scale.
timeFrame: Baseline; immediately after the intervention; and 3-months after the intervention
measure: Change from baseline in caregiver dietary intake as assessed by the Inflammatory Diet Index.
timeFrame: Baseline; immediately after the intervention; and 3-months after the intervention
measure: Change from baseline in patient dietary intake (food groups, macronutrient, micronutrient, and caloric intake) as assessed by the Automated Self-Administered 24-hour Dietary Assessment Tool
timeFrame: Baseline; immediately after the intervention; and 3-months after the intervention
Other outcomes:
measure: Participant experiences and perspectives on the culinary medicine program as assessed through qualitative data (in-depth interviews)
timeFrame: Immediately after the intervention; 3-months after the intervention
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