Culinary Medicine for Cancer Caregivers

NCT ID: NCT06523322

Last Updated: 2024-07-26

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-07-25
• Study Completion Date: 2025-01-30

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.

Conditions

Pediatric Cancer; Caregiver Burden; Cancer, Treatment-Related; Nutrition Aspect of Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Culinary Medicine plus Caregiver Coaching

8-week culinary medicine program, including 4 biweekly culinary medicine workshops and biweekly caregiver coaching.

Group Type: EXPERIMENTAL

Let's Cook Together

Intervention Type: BEHAVIORAL

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).

Interventions

Let's Cook Together

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).

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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

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

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Children's Hospital of Philadelphia

OTHER

Sponsor Role: collaborator

Drexel University

OTHER

Sponsor Role: lead

Responsible Party

Brandy-Joe Milliron

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Brandy-Joe Milliron, PhD

Role: CONTACT

bm645@drexel.edu

267-251-0902

Tracey Jubelirer, MD

Role: CONTACT

jubelirer@chop.edu

267-251-0902

References

Milliron BJ, Mountain P, Salman K, Longo G, Schlechter H, Deutsch JM, Jubelirer T. Culinary medicine for caregivers: protocol for a mixed-methods feasibility study to improve pediatric cancer patient and caregiver outcomes through nutrition and culinary support. Pilot Feasibility Stud. 2025 Sep 30;11(1):120. doi: 10.1186/s40814-025-01703-8.

Reference Type: DERIVED

PMID: 41029472 (View on PubMed)

Other Identifiers

23-021869

Identifier Type: -

Identifier Source: org_study_id