Culinary Medicine for Cancer Caregivers

Trial Title: Culinary Medicine for Cancer Caregivers

NCT ID: NCT06523322

Condition: Pediatric Cancer
Caregiver Burden
Cancer, Treatment-Related
Nutrition Aspect of Cancer

Conditions: Official terms:
Neoplasms, Second Primary
Caregiver Burden

Conditions: Keywords:
Culinary medicine
Nutrition
Cancer caregiver

Study type: Interventional

Study phase: N/A

Overall status: Not yet recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

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

Masking: None (Open Label)

Intervention:

Intervention type: Behavioral
Intervention name: Let's Cook Together
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).
Arm group label: Culinary Medicine plus Caregiver Coaching

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.

Criteria for 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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: Accepts Healthy Volunteers

Start date: July 25, 2024

Completion date: January 30, 2025

Lead sponsor:
Agency: Drexel University
Agency class: Other

Collaborator:
Agency: Children's Hospital of Philadelphia
Agency class: Other

Source: Drexel University

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06523322