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Culinary Nutrition Support for Caregivers of Pediatric Cancer Patients

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Study AimThe study aims to evaluate the acceptability, feasibility, usefulness, usability, and usage of a culinary nutrition support program for caregivers of children with cancer.
What is being tested

Let's Cook Together

Behavioral
Who is being recruted

Pediatric Cancer
+1

+ Caregiver Burden
+ Cancer, Treatment-Related
Over 18 Years

See all eligibility criteria

How is the trial designed

Supportive Care Study

Interventional
Study Start: July 2024

See protocol details

Summary

Principal SponsorDrexel University
Study ContactBrandy-Joe Milliron, PhD
Last updated: July 26, 2024
Sourced from a government-validated database.Claim as a partner
Study start date: July 25, 2024Actual date on which the first participant was enrolled.

This study is focused on improving the nutritional status and overall well-being of children undergoing cancer treatment and their caregivers. Pediatric cancer treatments can significantly impact a child's nutrition, which in turn affects their treatment tolerance and overall health. Caregivers also face emotional and psychological challenges that can affect their ability to care for their children. This study introduces an 8-week culinary nutrition program called Let's Cook Together, which aims to enhance caregivers' knowledge and skills in providing nutritious meals and managing treatment side effects. By increasing cooking confidence and dietary quality, the program seeks to support both the children and their caregivers in maintaining a healthy lifestyle during a challenging time. Participants in the study are caregivers of children receiving cancer treatment at the Children's Hospital of Philadelphia. The program includes four online cooking sessions led by a Medical Chef Educator and a Registered Dietitian Nutritionist, along with bi-weekly coaching sessions to discuss caregiving strategies and challenges. Participants receive nutrition education and recipes to support their learning. Throughout the program, assessments are conducted at the start, immediately after the program, and three months later to evaluate its feasibility and effectiveness. The study also gathers qualitative feedback to help refine the program and guide future research. The results aim to improve supportive care for families dealing with cancer treatment, providing valuable insights for healthcare professionals involved in oncology care.

Official TitleCulinary Medicine for Caregivers: Improving Pediatric Cancer Patient and Caregiver Outcomes Through Nutrition and Culinary Support 
Principal SponsorDrexel University
Study ContactBrandy-Joe Milliron, PhD
Last updated: July 26, 2024
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details
20 patients to be enrolledTotal number of participants that the clinical trial aims to recruit.
Supportive Care Study
These studies explore ways to improve comfort and daily life for people living with a condition. They may focus on easing symptoms, reducing treatment side effects, or supporting overall well-being.

How participants are assigned to different groups/arms
In this clinical study, all participants receive the same treatment. Since there is only one group, there is no need for randomization or assignment to different arms. This type of study is often used to test a new treatment without comparing it to another.

Other Ways to Assign Participants
Randomized allocation: Participants are assigned randomly, like flipping a coin, to ensure fairness and reduce bias.
Non-randomized allocation: Participants are assigned based on specific factors, such as their medical condition or a doctor's decision.

How treatments are given to participants
In this study, all participants receive the same treatment. This approach is often used to evaluate the effects of a single intervention without comparing it to another.

Other Ways to Assign Treatments
Parallel assignment: Participants are split into separate groups, each receiving a different treatment.
Cross-over assignment: Participants switch between treatments during the study.
Factorial assignment: Participants receive different combinations of treatments.
Sequential assignment: Participants receive treatments one after another in a specific order, possibly based on individual responses.
Other assignment: Treatment assignment does not follow a standard or predefined design.

How the effectiveness of the treatment is controlled
In a non placebo-controlled study, no participants receive an inert substance (placebo) to compare outcomes. Instead, all participants receive either the experimental treatment or an alternative treatment (often the Standard of Care). This method allows researchers to compare the effects of the experimental treatment with those of a different active intervention, rather than a placebo.

Other Options
Placebo-Controlled: A placebo is used to compare the effects of the experimental treatment with those of an inert substance, isolating the true treatment effect.

How the interventions assigned to participants is kept confidential
Everyone involved in the study knows which treatment is being given. This is typically used when it's not possible or necessary to hide the treatment details from participants or researchers.

Other Ways to Mask Information
Single-blind: Participants do not know which treatment they are receiving, but researchers do.
Double-blind: Neither participants nor researchers know which treatment is given.
Triple-blind: Participants, researchers, and outcome assessors do not know which treatment is given.
Quadruple-blind: Participants, researchers, outcome assessors, and care providers all do not know which treatment is given.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria
Any sexBiological sex of participants that are eligible to enroll.
Over 18 YearsRange of ages for which participants are eligible to join.
Healthy volunteers allowedIf individuals who are healthy and do not have the condition being studied can participate.
Conditions
Pathology
Pediatric Cancer
Caregiver Burden
Cancer, Treatment-Related
Nutrition Aspect of Cancer
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

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives
One single intervention group 

is designated in this study

This study does not include a placebo group 

Treatment Groups
Group I
Experimental
8-week culinary medicine program, including 4 biweekly culinary medicine workshops and biweekly caregiver coaching.
Study Objectives
Primary Objectives

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.

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.'

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

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.'

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.'
Secondary Objectives

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.

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.

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.

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.

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.

Study Centers

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