AzTrials
AzTrials

Pediatric CancerNCT06523322

Culinary Medicine for Cancer Caregivers

A study testing Let's Cook Together in people with Pediatric Cancer and Caregiver Burden, run by Drexel University.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
Let's Cook Together
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
No sites listed yet
Study dates
25 Jul 2024to 30 Jan 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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
  • Caregiver (parent or legal guardian) of a child who meets the inclusion and exclusion criteria for patients, above
Show all 10Show fewer
  • 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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Brandy-Joe Milliron, PhD contact

267-251-0902

bm645@drexel.edu

Tracey Jubelirer, MD contact

267-251-0902

jubelirer@chop.edu

About this study

Official title: 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.

Read the 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.

Being tested
Let's Cook Together
Keywords
Culinary medicine, Nutrition, Cancer caregiver
Medical subject headings
Neoplasms, Caregiver Burden, Neoplasms, Second Primary

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Let's Cook TogetherBehavioural

    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 groups in NCT06523322
Study groupRoleWhat they receive
Culinary Medicine plus Caregiver CoachingExperimental8-week culinary medicine program, including 4 biweekly culinary medicine workshops and biweekly caregiver coaching.
Receives: Behavioral: Let's Cook Together

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

  2. 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.'

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

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

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

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

  4. 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.'

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

  5. 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.'

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

Secondary outcomes (5)

  1. 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.

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

  2. 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.

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

  3. 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.

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

  4. 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.

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

  5. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted26 Jul 2024
  2. Study start25 Jul 2024 (estimated)
  3. Primary completion31 Oct 2024 (estimated)
  4. Study completion30 Jan 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
20 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06523322
Sponsor's protocol ID
23-021869
Status last verified
Jul 2024
First submitted
22 Jul 2024
Last updated
26 Jul 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 41029472

Questions about this trial

What is this clinical trial studying?

A study testing Let's Cook Together in people with Pediatric Cancer and Caregiver Burden, run by Drexel University.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 26 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Brandy-Joe Milliron, PhD (267-251-0902, bm645@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06523322, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2024.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in