Culinary Medicine for Cancer Caregivers

July 25, 2024 updated by: Brandy-Joe Milliron, Drexel University

Culinary Medicine for Caregivers: Improving Pediatric Cancer Patient and Caregiver Outcomes Through Nutrition and Culinary Support

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • Name: Brandy-Joe Milliron, PhD
  • Phone Number: 267-251-0902
  • Email: bm645@drexel.edu

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

*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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Culinary Medicine plus Caregiver Coaching
8-week culinary medicine program, including 4 biweekly culinary medicine workshops and biweekly caregiver coaching.
Behavioral: 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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Feasibility of the intervention as assessed by participant session attendance, assessment completion, and participant retention.
Time Frame: During the intervention; immediately after the intervention; and 3-months after the intervention
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.
Time Frame: During the intervention; immediately after the intervention; and 3-months after the intervention
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.
Time Frame: During the intervention; immediately after the intervention; and 3-months after the intervention
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.
Time Frame: During the intervention; immediately after the intervention; and 3-months after the intervention
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.
Time Frame: During the intervention; immediately after the intervention; and 3-months after the intervention
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change from baseline in preparedness for caregiving as assessed by the Preparedness for Caregiving Scale.
Time Frame: Baseline; immediately after the intervention; and 3-months after the intervention
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
Time Frame: Baseline; immediately after the intervention; and 3-months after the intervention
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.
Time Frame: Baseline; immediately after the intervention; and 3-months after the intervention
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.
Time Frame: Baseline; immediately after the intervention; and 3-months after the intervention
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
Time Frame: Baseline; immediately after the intervention; and 3-months after the intervention
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

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Participant experiences and perspectives on the culinary medicine program as assessed through qualitative data (in-depth interviews)
Time Frame: Immediately after the intervention; 3-months after the intervention
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Drexel University

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Children's Hospital of Philadelphia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 25, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 31, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 22, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 26, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 26, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 25, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 23-021869

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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