Culinary medicine for caregivers: protocol for a mixed-methods feasibility study to improve pediatric cancer patient and caregiver outcomes through nutrition and culinary support

Abstract

Introduction

Pediatric cancer and its treatment can negatively affect nutritional status, impacting treatment tolerance, survival, and overall well-being. Poorly managed side effects often lead to lasting poor dietary habits. Caregivers, who bear the psychosocial burden of these effects, are also at risk for diminished health. Interventions that support caregivers’ capacity to provide quality care while maintaining their own health are critically needed. Culinary medicine interventions have shown promise in improving cooking confidence, dietary quality, and symptom management. We developed an 8-week culinary medicine intervention, including caregiver coaching, to support pediatric cancer patients and their caregivers.

Methods

Let’s Cook Together is designed to increase caregivers’ knowledge of a whole foods dietary approach, improve caregiving preparedness, and boost self-efficacy in managing treatment side effects. Caregivers with children undergoing cancer treatment will be recruited from the Children’s Hospital of Philadelphia. The program includes four remote, biweekly cooking sessions led by a medical chef educator and a registered dietitian nutritionist, along with alternating coaching calls focused on caregiving goals and challenges. Participants will also receive written nutrition and cooking resources. This is a single-arm, explanatory sequential mixed-methods feasibility study. Quantitative assessments will be conducted at baseline, post-intervention, and 3-month post-intervention; qualitative interviews will follow the intervention. The primary objective is to assess feasibility and acceptability. Secondary objectives include collecting exploratory outcome data on caregiving preparedness, caregiver self-efficacy, pediatric feeding behaviors, and dietary intake to inform the design and sample size calculations for a future trial and to identify potential signals of intervention effect.

Discussion

Results will inform refinement of the intervention and study design and guide the development of a future trial. Findings may be relevant to oncology and allied health professionals involved in supportive care for families navigating pediatric cancer treatment.

Trial registration

 ClinicalTrials.gov, NCT06523322, Registered 22 July 2024, https://clinicaltrials.gov/study/NCT06523322.

Supplementary Information

The online version contains supplementary material available at 10.1186/s40814-025-01703-8.

Background

Cancer treatment side effects are a barrier to healthy survival in children with cancer and contribute to poor long-term dietary behaviors [1]. Nutritional status is fundamental to treatment tolerance, survival, and quality of life [1–4]. However, therapies such as chemotherapy often lead to nausea, vomiting, diarrhea, loss of appetite, and fatigue, symptoms that may contribute to malnutrition rates as high as 75% and are linked to decreased immunity, poor treatment adherence, and reduced psychosocial functioning [5]. In addition to malnutrition, treatment can lead to long-term poor dietary behaviors [6–8]. Research shows post-diagnosis decreases in fruit and vegetable intake and increases in ultra-processed food consumption. These changes may be reinforced by well-intentioned efforts to prevent weight loss during treatment [6]. In light of these trends, culinary medicine, an approach that combines the art of cooking with evidence-based nutrition education and behavioral change, may offer a feasible, non-pharmacologic strategy to improve dietary intake and manage treatment side effects [9].

Although caregiving is fulfilling, caregivers, particularly parents, endure significant psychological and physical stress as they manage cancer treatment and its side effects [10, 11]. Many report insufficient knowledge and confidence to address nutrition-related symptoms, despite receiving anticipatory guidance [12–14]. This gap contributes to distress and a sense of unpreparedness that can negatively impact both caregiver and patient outcomes. For example, cancer caregiving has been associated with elevated rates of depression, anxiety, sleep disruption, and poor dietary behaviors, including suboptimal dietary intake [15, 16]. These declines in caregiver health may reduce their caregiving capacity [17–19]. Culinary medicine interventions may help mitigate this by simultaneously improving caregivers’ own health and equipping them to support their children’s nutrition during treatment.

Despite the recognized importance of caregiver self-care, few supportive interventions target caregiver nutrition or prepare them to manage treatment side effects. Culinary medicine offers a promising, evidence-informed approach to enhance caregiver self-efficacy, improve household dietary behaviors, and reduce reliance on pharmacologic symptom management.

Culinary medicine brings together cooking skills, nutrition education, and behavior change strategies to support disease prevention and management with high-quality, nutrient-dense foods in conjunction with appropriate medical care [9]. These interventions have been shown to improve cooking confidence, dietary quality, and even long-term health outcomes among cancer survivors [20–24].

Study objectives

The primary objective of this feasibility study is to provide evidence for the feasibility and acceptability of an 8-week culinary medicine intervention with coaching for caregivers of children undergoing cancer treatment. The secondary objective is to collect exploratory outcome data on caregiving preparedness, caregiver self-efficacy for managing patient treatment side effects, behavioral pediatric feeding behaviors, and dietary intake of both caregivers and children. These data will be used to estimate variability, assess measurement procedures, and identify potential signals of intervention effect to inform the selection of outcome measures and sample size calculations for a future trial. Semi-structured interviews will explore caregiver experiences and perspectives on the feasibility and acceptability of the culinary medicine intervention and to inform interpretation of findings and future program refinement.

Methods

Study design and setting

This is a single-arm, explanatory sequential mixed-methods feasibility study. This study aims to recruit caregiver-child dyads. In this study, caregivers are defined as a parent or legal guardian of the child receiving treatment for cancer. Participants will be recruited from three outpatient oncology clinics of the Children’s Hospital of Philadelphia (CHOP).

This protocol is reported in accordance with SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidance. A completed SPIRIT checklist is available in Additional file 1.

Study population

In this study, a caregiver and their child receiving treatment for cancer (caregiver-child dyad) will be invited to participate in the culinary intervention. While only the caregiver will be participating in the intervention, both caregiver and child are considered participants due to data extraction procedures from patient chart reviews. This feasibility study is not powered to detect statistically significant effects but rather to provide evidence of feasibility and acceptability and inform the design of a future trial. Ten caregiver-child dyads will be enrolled in the program using convenience sampling (N = 20, 10 children and 10 caregivers). This sample size is consistent with methodological recommendations for feasibility and pilot studies, which suggest that approximately 12 participants per group provides reasonable precision for estimating key parameters needed to plan a future trial while avoiding unnecessary participant burden [25–27]. As Teresi (2022) notes, sample size in feasibility studies should be driven by logistical considerations and the ability to assess predefined feasibility thresholds, rather than by hypothesis testing. This sample size will allow us to engage with each participant in a detailed way as follows: better understand their experiences and perspectives on the culinary medicine program, help us begin to understand feasibility and acceptability of the program, and inform interpretation of study findings and program refinement, if future programming is warranted.

Eligibility criteria

Pateint eligibility

Children will be eligible to participate if they meet all of the following criteria:

• Receiving active cancer treatment for a liquid or solid cancer diagnosis

• Between 4 and 21 years of age

• English-speaking

• Taking greater than 50% of their intake orally (PO)

• Approved to participate by both their oncologist and registered dietitian nutritionist (RDN)

Exclusion criteria (patients)

• Undergoing bone marrow transplantation

• Receiving active treatment for a brain tumor

Caregiver eligibility

Caregivers will be eligible to participate if they meet all of the following criteria:

• A caregiver (parent or legal guardian) of a child who meets patient eligibility criteria

• English-speaking and able to read and understand study materials

• Have access to a computer or Internet-enabled device (i.e., tablet, laptop, desktop computer)

• At least 18 years of age

• Able to provide informed consent

Intervention

The 8-week Let’s Cook Together program is intended to increase the following: 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, group-based remote culinary medicine intervention, including four biweekly remote synchronous culinary workshops (one 90-min introductory event and three 90-min culinary/cooking sessions) and four biweekly caregiver coaching telephone calls (lasting 15–20 min). Grounded in social cognitive theory, our study hypothesizes that combining culinary medicine training with caregiver coaching can address key barriers to healthy nutrition in pediatric cancer care [28–30]. The intervention is designed to reduce treatment-related side effects; enhance caregiver knowledge, preparedness, and self-efficacy; and ultimately improve dietary intake for both children and caregivers by supporting behavior change through goal-setting, problem-solving, and reflective motivation.

Intervention content and delivery

Culinary workshops will be led by CHOP’s medical chef educator along with an RDN via four remote synchronous sessions (one introductory event and three 90-min culinary/cooking sessions) using CHOP Microsoft Teams. Educational and reinforcement materials will include didactic educational materials, recipes, and a caregiver culinary starter kit, which will include essential ingredients (e.g., almond flour, turmeric, honey, chia seeds) and program-branded gifts (e.g., spatula, kitchen towel). Each family will receive a program binder, a culinary starter kit, and a US $100 grocery/ingredient gift card. Sessions will be interactive, and caregivers will be encouraged to cook alongside. Culinary sessions will demonstrate recipes that are simple and easy to follow and low cost to ensure all families may benefit, support a range of symptom management, and enhance overall health and wellness by incorporating nutrient dense and minimally processed ingredients. The first culinary workshop includes an introduction to the program with an overview of the culinary workshop structure, food safety guidelines, nutrition literacy, and recommended food storage practices, including guidance on minimizing food waste. Each subsequent culinary workshop will begin with a 20-min didactic session, followed by a review of the ingredients that will be used and their function, demonstration of four recipes with side-by-side instruction (preparation of breakfast, beverage, entrée, and snack/dessert recipes), a brief review of food storage and batch cooking techniques, and debriefing with Q&A. Following the introductory workshop, each of the three remaining workshops will focus on culinary approaches to alleviating or addressing a specific treatment side effect: (1) High-calorie recipes (to address anorexia/poor appetite), (2) nausea, and (3) constipation and GI health.

Caregiver coaching calls will occur biweekly with a CHOP RDN. These 15–20-min calls provide an opportunity to check in with caregivers and discuss caregiving goals, challenges, and problem-solving strategies and to provide support and guidance. Feasibility data will be collected during these calls, including caregiver perspectives on culinary workshop acceptability and usefulness. Table 1 summarizes the schedule of study procedures.

Table 1.

Schedule of study procedures

Study phase	Screening	Baseline	Remote intervention study visits								Follow-up visit
Weeks			1	2	3	4	5	6	7	8	20
Medical record review	X
Informed consent		X
Review inclusion/exclusion criteria	X
Feasibility metrics			X	X	X	X	X	X	X	X	X
Acceptability metrics				X		X		X		X	X
Questionnaires											X
Demographics		X
Preparedness for Caregiving Scale		X								X	X
Caregiver self-efficacy for management treatment side effects		X								X	X
Behavioral Pediatrics Feeding Assessment Scale		X								X	X
Dietary assessment		X								X	X
Perceived usefulness										X	X
In-depth interviews										X

Outcomes

The feasibility, acceptability, and perceived usefulness outcomes described below and outlined in Tables 1 and 2 are the primary outcome measures being assessed in this feasibility study. To characterize the sample, self-report information will be collected regarding race, ethnicity, sex, gender, income, education, food security, child diagnostic and treatment information, and caregiving characteristics.

Table 2.

Feasibility and acceptability progression criteria

Outcome	Measure	Criteria
Recruitment feasibility	Participants enrolled per month of recruitment	≥ 5 dyads/month
Retention feasibility	Percent of participants providing assessment data at 8 weeks	≥ 75%
Assessment feasibility	The proportion of retained participants who provide valid data for each assessment task	≥ 95%
Intervention acceptability	Intervention acceptability survey	Median score ≥ 4
Intervention engagement	Percent of participants attending ≥ 3 culinary sessions, percent of participants attending the ≥2 coaching sessions	≥ 75%
Progression criteria	Feasibility will be determined by whether the intervention meets at least 4 out of 5 of the defined feasibility and acceptability progression criteria. Meeting these criteria will support the decision to proceed to a future definitive trial

Feasibility and acceptability outcomes

Feasibility and acceptability outcomes will be assessed using both quantitative and qualitative indicators. Consistent with Mellor et al.’s [31] recommendations for feasibility trials, we have defined specific progression criteria to determine whether the study procedures are practicable and whether to proceed to a larger trial.

• Recruitment feasibility (≥ 5 dyads/month): This criterion was based on realistic projections from prior recruitment efforts at the participating clinical sites and reflects both staff capacity and the burden experienced by our caregiver population. A slower recruitment rate may indicate limited reach or engagement potential for a scaled intervention.

• Retention (≥ 75%) and assessment (≥ 95%) feasibility: At least 75% of enrolled participants are expected to complete post-intervention assessments at 8 weeks, and at least 95% of participants retained at 8 weeks should provide valid data for each assessment task. These thresholds are drawn from feasibility literature suggesting that ≥ 70–80% retention is often needed to justify trial viability, especially for vulnerable populations [26, 32, 33]. A high assessment completion rate among retained participants ensures that the study procedures are acceptable and minimally burdensome.

• Intervention engagement (≥ 75% of participants attend ≥ 3 of 4 culinary sessions and ≥ 2 of 4 coaching calls): This threshold aligns with criteria used in similar behavioral interventions, where attending at least 75% of sessions is associated with increased knowledge retention and behavior change.

• Acceptability: Measured via a post-intervention survey including items rated on a 5-point Likert scale (1 = strongly disagree to 5 = strongly agree, neutral option included). Sample items include the following:

  • o
    “The culinary medicine information was easy to understand.”
  • o
    “The content was personally relevant to me and/or my child.”
  • o
    “The amount of information presented was appropriate.”
  • o
    A median score of ≥ 4.0 on each item will indicate acceptable levels of intervention acceptability.

• Progression criteria: Feasibility will be determined by whether the intervention meets at least 4 out of 5 of the defined feasibility criteria. Meeting these criteria will support the decision to proceed to a future definitive trial.

Perceived usefulness will be measured via post-intervention and 3-month follow-up surveys across three sub-domains as follows:

• oUsage: E.g., “Did you use any of the recipes?”
• oUsability: E.g., “I thought the recipes were easy to make.”
• oPerceived benefit: E.g., How useful was the culinary nutrition series in helping you to… “Increase your confidence in helping reduce your child’s nutrition-related side effects”/“Increase your knowledge on food preparation/meal planning to best support your child.”
• oWhen relevant, Likert scales were used and included a neutral option.

Exploratory outcome data

Exploratory outcome data will be collected at baseline, post-intervention, and 3-month post-intervention. These data will include caregiving preparedness, caregiver self-efficacy for managing patient treatment side effects, behavioral pediatric feeding behaviors, and dietary intake. 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 [34]. Answers are given using a 5-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.

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 [35, 36]. 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 that assesses behaviors associated with poor nutritional intake [37]. 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 consideredconsiders the behavior to be a problem (“yes” or “no”). The BPFAS focuses on behavioral problems related to food refusal or poor nutritional intake and has been used to assess eating and feeding behaviors in children with medical problems such as cancer, cCystic Ffibrosis, diabetes, and gastrointestinal disorders. [37–41].

Caregivers will complete the Automated Self-Administered 24-h Dietary Assessment Tool (ASA24) at each assessment time point for themselves and on behalf of the patient (their child) to collect information on dietary patterns, macronutrient, micronutrient, and total caloric intake. ASA24 is an electronic-based dietary recall that is available free of charge through the National Cancer Institute [42]. To minimize burden on participants, for those who need a little extra support in completing the recalls, and for those who find the technological aspect cumbersome, our research team will obtain the recall over the phone and enter the information into the ASA24 system. We have successfully used this method in several other studies to minimize burden for participants. Computer-based 24-h food recalls are a cost-effective approach for measuring dietary intake in the clinical setting [43]. In ASA24, participants are guided through the program with the aid of food images and multiple passes.

Qualitative outcomes

Semi-structured interviews with caregivers will be conducted to explore their experiences and perspectives on the culinary nutrition 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.

Recruitment

Identification of participants

Participants will be recruited from the CHOP outpatient oncology clinic at three sites. A research coordinator will work with clinicians caring for patients to identify those that are eligible, as well as review medical records to screen for study eligibility. If eligibility criteria are met, the research coordinator will approach the caregiver to evaluate interest in the study. If a caregiver is interested in participating, consent for both the caregiver and child participation and child assent will be obtained. Again, for the purposes of this study, “caregiver” refers to the legal parent or guardian of the child receiving treatment.

Data collection

The study duration will be up to 5 months. For each individual, this includes 1 day of screening, 8 weeks of intervention, immediate post-intervention assessment, and up to 2 days of follow-up assessment at 3-months post-intervention (5 months after study initiation). Table 1 summarizes the data collection timeline for all outcome measures.

Quantitative data

Patient medical record data extraction will occur after informed consent and assent have been provided. Extracted data will include race and ethnicity, age, gender, diagnosis, treatment, date of diagnosis, relapse (yes/no; if yes, first cancer diagnosis type and treatment), and zip code of residence. Feasibility and acceptability metrics will be collected on an ongoing basis as well as during post-intervention assessment. Exploratory outcome data will be collected at baseline, post-intervention, and 3-month post-intervention.

A research coordinator will work with clinicians caring for patients to identify those that are eligible, as well as review the medical record to screen for study eligibility. If eligibility criteria are met, the research coordinator will approach the caregiver of the child to evaluate interest in the study. If a caregiver is interested in participating, consent will be obtained for participation of both the caregiver and child in the study. At this time, if the caregiver is able to complete the pre-intervention assessments, they will do so with the research coordinator using a tablet in the clinic. The pre-intervention survey will be administered via REDCap and the web-based dietary assessment.

For caregivers who are unable to complete the pre-intervention surveys in clinic after they provided consent and assent for participation, a survey link and a link to the dietary assessment with log-in details will be emailed to the participant by the research coordinator. The research coordinator will work with program participants and study team members to schedule the culinary sessions and coaching calls. The research coordinator will send reminder messages for the culinary workshops and coaching calls 3 days prior to the event, 1 day prior to the event, and day of the event. During the final coaching visit (week 8), caregivers will complete post-intervention assessments. For 3-month follow-up assessments, caregivers will receive an email containing links to the web-based survey and web-based dietary assessment.

Qualitative data

Interviews will be conducted using HIPAA-compliant Teams, audio-recorded, and will last approximately 30 min. Interviews will be conducted by a trained team member and will be transcribed verbatim. Participants will be offered a US $25 gift card for interview completion.

Quantitative and qualitative data analysis

The primary endpoint will be feasibility and acceptability of the culinary medicine program along the study progression criteria displayed in Table 2. Summary statistics will be selected based on variable type and distribution. For continuous variables, if normally distributed, we will report means and standard deviations; if not, medians and interquartile ranges (IQRs) will be used. For categorical variables, data will be summarized using frequencies and percentages. Ordinal Likert-type data will be reported as medians with IQRs, consistent with common practice for nonparametric data. We will assess normality using visual inspection. All quantitative data will be analyzed using IBM SPSS Statistics, Version 28.0 (Armonk, NY: IBM Corp.).

Feasibility and acceptability outcomes will be analyzed using descriptive statistics and interpreted in relation to predefined progression criteria, consistent with guidance from Mellor et al. [31]. Each criterion—covering recruitment, retention, assessment completion, intervention engagement, and acceptability—has been selected based on prior literature and contextual factors, including caregiver burden, intervention logistics, and thresholds commonly used in behavioral trials. Likert-scale items (1 = strongly disagree to 5 = strongly agree) assessing acceptability will be summarized using median scores; a median ≥ 4.0 on individual items will indicate an acceptable or useful intervention. Feasibility will be established if at least 4 of the 5 defined criteria are met, thereby supporting progression to a future definitive trial. Beyond the progression criteria for feasibility and acceptability, we will also illustrate acceptability using frequency (percentage) to enhance interpretation. Qualitative data will complement these analyses by providing deeper insight into participants’ experiences and contextualizing quantitative findings.

Qualitative data from semi-structured interviews will be audio recorded, transcribed verbatim, analyzed thematically, and reported according to the Standards for Reporting Qualitative Research (SRQR). Interviews will be transcribed and coded using MAXQDA software. A priori codes (e.g., intervention accessibility, perceived relevance and usefulness, and engagement and satisfaction) will identify thematic content related to key program processes and outcomes. Emergent codes will be developed during initial memoing. A structured codebook will be developed based on the first four transcripts. Two team members will code all transcripts and discuss emerging themes with a third team member. Themes will be reviewed by other research team members to ensure that they are a reliable reflection of participants’ experiences. The confirmability, credibility, dependability, and transferability criteria will be used to ensure trustworthiness of qualitative data [44]. Confirmability will be established by recording all research-related activities. Credibility will be ensured through peer-checking, whereby the research team will assess the codes and themes and verified the accuracy of data analysis. Dependability will be maintained through data analysis by two team members. Transferability will be ensured through purposive sampling of program participants. The integration of quantitative and qualitative data will occur during the analysis and interpretation phases [45].

Withdrawal

Participants may withdraw from the study at any time without prejudice to their care or their child’s care. It will be documented whether or not each subject completes the study. If the investigator becomes aware of any serious, related adverse events after the subject completes or withdraws from the study, they will be recorded in the source documents.

Potential benefits and risks of study participation

The long-term goal of this study is to improve pediatric cancer patient and caregiver outcomes through nutrition and culinary support. The nutrition education component helps participants understand why they should make a change while the culinary medicine piece provides participants with the tools to do so. Coaching helps participants connect what they have learned and personalize it to fit into their unique life with their unique child. Most importantly, coaching provides participants a safe space to ask questions, share concerns, and learn. Therefore, parents/caregivers may experience benefits to participating in this study, potentially including the following:

• New knowledge about the benefits of a whole-foods approach to healthful eating

• New motivation to engage in pro-health behaviors

• New knowledge about the lifestyle behaviors that positively contribute to cancer prevention and healthy cancer survivorship

• Increased preparedness and self-efficacy for managing their child’s nutrition-related cancer treatment side effects

• Enhanced overall health and wellness through incorporating nutrient dense and minimally processed ingredients into family meals.

There is also a possibility that participants in this study may not directly benefit from participating in this research. However, all participants may indirectly benefit from participation due to the benefits that accrue to future families who experience a pediatric cancer diagnosis.

The research team does not anticipate the occurrence of any type of adverse event associated with participation in this study. The research poses minimal risk, if any at all, to the participants.

Participants may experience emotional discomfort or upsetting memories during the didactic portion of the culinary intervention when the instructor describes common nutrition-related treatment side effects and potential methods for side effects mitigation. Although minimal, additional risks may include emotional discomfort during coaching telephone calls when discussing any challenges they are experiencing related to the intervention activities and emotional discomfort during semi-structured interviews when discussing their experience(s) during the culinary intervention.

Data monitoring

The principal investigators will monitor and review the study progress, participant safety, and the accuracy and security of the emerging data. All information collected in this study will be kept confidential as required by law. Names will not be attached to the study participants, and a master list, as well as data elements and survey responses, will be kept in a secure and encrypted database, which can only be accessed by research team members. Due to the low-risk nature of the intervention, a Data and Safety Monitoring Board has not been formally established. All adverse events will be reported to the principal investigators and the Institutional Review Boards and reviewed by the study team to determine whether the study should be discontinued due to participant safety. Changes to the protocol will be communicated by the principal investigators to all study stakeholders.

Ethics and dissemination

Research ethics approval

This study has been approved by the Children’s Hospital of Philadelphia Institutional Review Board (IRB approval number: 23-021869). The details of this study have been submitted to the ClinicalTrials.gov registry.

Consent and assent

Written informed consent for both caregiver and child participation and HIPAA authorization for child participation are required from all study participants. For patients (children less than 18 years of age), this will be obtained from their caregiver, with written informed assent also collected from the patient if they are at least 7 years old. HIPAA authorization is required because we will be extracting patient data from the electronic medical records (date, race and ethnicity, age, gender, diagnosis, treatment, date of diagnosis, relapse (yes/no; if yes, first cancer diagnosis type and treatment), zip code of residence). Participants will be given the opportunity to discuss the study with their surrogates or think about it prior to agreeing to participate. They may withdraw consent at any time throughout the course of the study. Participants will be provided a copy of the informed consent documents for their records after they consent to the study procedures.

Confidentiality

All data and records generated during this study will be kept confidential in accordance with institutional policies and HIPAA on subject privacy, and that the investigators and other site personnel will not use such data and records for any purpose other than conducting the study. No identifiable data will be used for future study without first obtaining IRB approval or IRB determination of exemption. Participant confidentiality is strictly held in trust by the investigators, study staff, and the sponsor and their agents. The study protocol, documentation, data, and all other information generated will be held in strict confidence. No information concerning the study or data will be released to any unauthorized third party without prior written approval of the sponsor. The study monitor or other authorized representatives of the sponsor may inspect all study documents and records required to be maintained by the investigator. Confidentiality will be protected by including only information needed to assess study outcomes, minimizing to the fullest extent possible the collection of any information that could directly identify participants, and maintaining all study information in a secure manner. To ensure participant privacy and confidentiality, a unique study identifier will be assigned to each participant. Data and records will be kept locked and secured with any computer data password-protected. The identifiers and other data will be destroyed 6 years after study completion in compliance with CHOP Data Retention Policy.

Dissemination

We will disseminate the study findings through conference presentations and publications in peer-reviewed international journals. Only aggregate data without individually identifiable information will be published. As this study is a feasibility study, the results will be used to inform and develop a larger trial, if appropriate.

Discussion

Poorly managed cancer treatment side effects can significantly impair nutritional status in children with cancer, reducing treatment tolerance, compromising survival, and diminishing overall well-being. These challenges may also contribute to long-term poor dietary habits. Caregivers, who bear the emotional and physical burden of supporting a child through treatment, often experience adverse impacts on their own health and wellness.

This protocol describes a single-arm, explanatory sequential mixed-methods feasibility study of an 8-week culinary medicine intervention, Let’s Cook Together, which integrates caregiver coaching to support nutrition-related caregiving. The primary objective is to provide evidence for feasibility and acceptability of the intervention. Secondary objectives include collecting exploratory outcome data on caregiving preparedness, caregiver self-efficacy for managing patient treatment side effects, pediatric feeding behaviors, and dietary intake. To guide interpretation of feasibility, we have adopted progression criteria as recommended by Mellor et al. [31]. Specifically, we will assess recruitment, retention, and assessment feasibility, intervention acceptability, and engagement against predefined thresholds. Meeting at least four of these five criteria will indicate feasibility and inform the decision for scaling to a larger trial.

Authors’ contributions

Conceptualization, BJM, TJ, PM, JMD, HS, and GL; writing—original draft preparation, BJM, TJ, JMD, and KS; funding acquisition, TJ, BJM, and PM; writing—review and editing, BJM, TJ, PM, JMD, HS, GL, and KS; and writing—revision draft preparation, BJM and TJ. All authors have read and agreed to the current version of the manuscript.

Funding

This study is funded by Wit You Against Childhood Cancer.

Data availability

There are no datasets associated with this manuscript yet, as this is a protocol paper. However, when the datasets become available, availability can be made upon request.

Declarations

Ethics approval and consent to participate

This study has been approved by the Children’s Hospital of Philadelphia Institutional Review Board (IRB approval number: 23–-021869). Written informed consent for both caregiver and child participation and HIPAA authorization for child participation isare required from all study participants.

Consent for publication

Not applicable.

Competing interests

The authors declare that they have no competing interests.