Culinary Medicine for Cancer Caregivers

NCT06523322 | Not Yet Recruiting

• 1 other identifier: 23-021869
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

Culinary medicine; Nutrition; Cancer caregiver

Outcome Measures

Primary Outcomes (5)

• Feasibility of the intervention as assessed by participant session attendance, assessment completion, and participant retention.

  Objective metrics will be used to determine feasibility, including the number of participants enrolled per month of recruitment, the percent of participants who provide assessment data at 8 weeks, and the proportion of retained participants who provide valid data for each assessment task. The percent of participants who attend all sessions and complete all assessments will be used as a metric for feasibility.

  During the intervention; immediately after the intervention; and 3-months after the intervention

• Acceptability of the intervention as assessed by comprehension of intervention content, personal relevance, and appropriate information volume.

  Acceptability will be measured along a 5-point Likert scale to questions that ask whether the culinary medicine information was easy to understand, personally relevant, and whether the amount of information presented was appropriate. Intervention acceptability will be expressed as the percent of participants who rate each of the previous domains as 'agree' or 'strongly agree.'

  During the intervention; immediately after the intervention; and 3-months after the intervention

• Usage of the intervention as assessed by the number of recipes used.

  Usage will be measured according to the number of recipes used.

  During the intervention; immediately after the intervention; and 3-months after the intervention

• Usability of the intervention as assessed by ease of use and plan for continued use.

  Usability will be measured along a 5-point Likert scale to questions that ask participants the extent to which the recipes were easy to use and plan for continued use. Intervention usability will be expressed as the percent of participants who rate each of the previous domains as 'agree' or 'strongly agree.'

  During the intervention; immediately after the intervention; and 3-months after the intervention

• 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.

  Perceived usefulness will be measured along a 5-point Likert scale to questions ask the extent to which the session was useful in helping participants to increase their confidence, overcome barriers, and increase the support they receive. Perceived usefulness will be expressed as the percent of participants who rate each of the previous domains as 'agree' or 'strongly agree.'

  During the intervention; immediately after the intervention; and 3-months after the intervention

Secondary Outcomes (5)

• Change from baseline in preparedness for caregiving as assessed by the Preparedness for Caregiving Scale.

  Baseline; immediately after the intervention; and 3-months after the intervention

• 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

  Baseline; immediately after the intervention; and 3-months after the intervention

• Change from baseline in caregiver eating-related distress as assessed by the Behavioral Pediatrics Feeding Assessment Scale.

  Baseline; immediately after the intervention; and 3-months after the intervention

• Change from baseline in caregiver dietary intake as assessed by the Inflammatory Diet Index.

  Baseline; immediately after the intervention; and 3-months after the intervention

• 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

  Baseline; immediately after the intervention; and 3-months after the intervention

Other Outcomes (1)

• Participant experiences and perspectives on the culinary medicine program as assessed through qualitative data (in-depth interviews)

  Immediately after the intervention; 3-months after the intervention

Study Arms (1)

Culinary Medicine plus Caregiver Coaching

EXPERIMENTAL

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

Behavioral: Let's Cook Together

Interventions

Let's Cook Together 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).

Culinary Medicine plus Caregiver Coaching

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Drexel University: lead
• Children's Hospital of Philadelphia: collaborator

Related Publications (1)

• 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.

  PMID: 41029472 DERIVED

MeSH Terms

Conditions

Neoplasms; Caregiver Burden; Neoplasms, Second Primary

Condition Hierarchy (Ancestors)

Stress, Psychological; Behavioral Symptoms; Behavior

Central Study Contacts

Brandy-Joe Milliron, PhD

CONTACT

267-251-0902; bm645@drexel.edu

Tracey Jubelirer, MD

CONTACT

267-251-0902; jubelirer@chop.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: 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).

Study Record Dates

• First Submitted: July 22, 2024
• First Posted: July 26, 2024
• Study Start: July 25, 2024
• Primary Completion: October 31, 2024
• Study Completion: January 30, 2025
• Last Updated: July 26, 2024

Record last verified: 2024-07