Culinary Medicine for Cancer Caregivers
NCT Number: NCT06523322
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Pediatric Cancer|Caregiver Burden|Cancer, Treatment-Related|Nutrition Aspect of Cancer
Interventions: BEHAVIORAL: Let's Cook Together
Sponsor: Drexel University
Collaborators: Children's Hospital of Philadelphia
Sex: ALL
Age: ADULT, OLDER_ADULT
Enrollment: 20
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2024-07-25
Completion Date: 2025-01-30

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.

Primary Outcome Measures: 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 Outcome Measures: Change from baseline in preparedness for caregiving as assessed by the Preparedness for Caregiving Scale., Caregiving Preparedness will be assessed using the Preparedness for Caregiving Scale, an 8-item survey that assesses caregivers' readiness to provide care for the patient and includes multiple domains of caregiving, such as providing physical care and emotional support. Answers are given using a five-point Likert-type scale (answers range from 'not at all prepared' \[0\] to 'very well prepared' \[4\]). Overall preparedness will be determined by calculating the average of the eight survey items. Higher scores indicate better preparedness., 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, Caregiver self-efficacy will be assessed using the Caregiver Self-Efficacy for Management of Treatment Side Effects survey, a 16-item survey to assess caregiver confidence in their abilities to manage cancer treatment side effects. Item ratings range from 10 (very uncertain) to 100 (very certain), where higher scores indicate greater self-efficacy. Overall self-efficacy is calculated using the mean of the 16 items. Additional scores will be calculated for self-efficacy for managing function-related side effects, pain, and 'other' side effects. 'Other' side effects include fatigue, lack of appetite, nausea, shortness of breath, feeling blue and frustration., 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., The Behavioral Pediatrics Feeding Assessment Scale (BPFAS) is a 35-item scale assesses behaviors associated with poor nutritional intake. The first 25 questions focus on the child's behavior and the next 10 questions focus on parental feelings or strategies for dealing with eating problems. Each item displays a descriptive phrase for which the caregiver is asked to rate how often the behavior occurs on a 5-point Likert scale from "never" to "always" and whether or not the caregiver considered the behavior to be a problem (yes" or "no"). Higher scores indicate greater eating-related distress., 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., Dietary intake will be collected and analyzed using the Diet History Questionnaire III (DHQ III), developed by the National Cancer Institute, Bethesda, MD. The DHQ III is a freely available, web-based food frequency questionnaire for use with adults 19 or more years of age. The DHQ III consists of 135 food and beverage items and 26 dietary supplement questions and can be used to examine dietary intake over the previous month. Participant responses to the DHW III will be scored for the inflammatory index of their diet using the Dietary Inflammatory Index (DII). Scores range from -8.87 to 7.98. Higher scores indicate greater inflammatory property of diet., 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, Caregivers will complete the Automated Self-Administered 24-hour Dietary Assessment Tool (ASA24) on behalf of the patient (their child) to collect information on dietary patterns and total caloric intake. ASA24 is an electronic-based dietary recall that is available free of charge through the National Cancer Institute., Baseline; immediately after the intervention; and 3-months after the intervention
Other Outcome Measures: Participant experiences and perspectives on the culinary medicine program as assessed through qualitative data (in-depth interviews), In-depth interviews with caregivers will be conducted to explore their experiences and perspectives on the culinary medicine program to inform interpretation of findings and scale-up. For example, interviews will explore factors that hinder or facilitate use of recipes provided and strategies described during classes and will explore participants' interest in continued use of recipes and strategies as a preliminary indicator of program engagement and dissemination potential., Immediately after the intervention; 3-months after the intervention