Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors (CHEF)

The goal of the Cardiovascular Health Equity Through Food (CHEF) program is to make it easier for participants and families to cook and eat healthy foods during and following childhood cancer treatment with the long-term goal of supporting heart health.

Study Overview

• Status: Recruiting
• Conditions: Childhood Cancer; Childhood Cancer Survivors
• Intervention / Treatment: Behavioral: CHEF Intervention Program

Detailed Description

This is a proof-of-concept study to test the CHEF intervention by utilizing survey, interview, and medical record data from participants with cancer to determine the intervention's impact on cardiovascular-relevant outcomes and to identify optimal implementation strategies for the intervention.

The research study procedures include screening for eligibility, questionnaires, and a brief interview.

Participation in this research study is expected to last 6 months.

It is expected about 17 participants/families will participate in this research study.

• Study Type: Interventional
• Enrollment (Estimated): 17
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahela Aziz-Bose, MD; Phone Number: 617-632-3352; Email: Rahela_aziz-bose@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Recruiting
      • Boston Children's Hospital
      • Contact: Rahela Aziz-Bose, MD; Phone Number: 617-632-3352; Email: Rahela_aziz-bose@dfci.harvard.edu
      • Principal Investigator: Rahela Aziz-Bose, MD
    • Boston, Massachusetts, United States, 02215
      • Recruiting
      • Dana-Farber Cancer Institute
      • Contact: Rahela Aziz-Bose, MD; Phone Number: 617-632-3352; Email: Rahela_aziz-bose@dfci.harvard.edu
      • Principal Investigator: Rahela Aziz-Bose, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Child with any primary cancer diagnosis (non-relapsed, non-secondary malignancy) who has received cancer-directed therapy that includes chemotherapy and/or radiation therapy;

• Child is within one of the following time windows:

  1. Among those receiving chemotherapy, any time from start of last planned cycle of chemotherapy until 12 months from completion of chemotherapy;
  2. Among those receiving radiation therapy alone or radiation and surgery, any time from completion of radiation until 12 months post completion;
• Child has 1 or more cardiovascular risk factor (defined as any of: body mass index ≥ 85th percentile; systolic or diastolic blood pressure ≥90th percentile; dyslipidemia [triglycerides ≥150 mg/dL, total cholesterol ≥200 mg/dL, LDL cholesterol ≥130 mg/dL, HDL cholesterol ≤40 mg/dL]; impaired glucose metabolism [fasting glucose ≥100 mg/dL, hemoglobin A1c ≥5.7%]; anthracycline exposure ≥100 mg/m2; or any radiation exposure to chest, brain, thoracic spine, or total body);
• Child is ≤18 years of age at time of enrollment, or over 18 years of age but under medical guardianship;
• Parent/guardian screened positive for food insecurity.* *Assessed through validated 2-item food insecurity screen.

Exclusion Criteria:

• Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
• Foreign national family receiving cancer care as an embassy-pay patient.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CHEF Program; Enrolled participants and caregivers will complete: Baseline visit and survey; Meeting with a certified benefits counselor by phone or video teleconference; Kitchen equipment delivery; Weekly meal kit deliveries; Monthly grocery support via gift card; Second meeting with a certified benefits counselor; 3-month survey; Final survey and interview with study staff

Behavioral: CHEF Intervention Program; Poverty-targeted intervention utilizing direct resource provision of healthy meal kits and groceries, as well as assisted referral and enrollment in government nutrition assistance benefits, SNAP (Supplement Nutrition Assistance Program) and/or WIC (Woman, Infants, and Children Program). Meal kits will be delivered by a commercial meal kit vendor. Grocery gift cards will be delivered via email, mail, or in-person. Kitchen equipment will be delivered to caregiver residence.; Other Names: Cardiovascular Health Equity Through Food Program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Dietary Quality Score	The change in mean participant dietary quality from study period T1 (baseline) to study period T3 (month 6), as measured by the Rapid Prime Dietary Quality Score Screener (scored 0-52, higher score indicates higher quality diet).	From baseline to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Food Security Status	Change in the proportion of participants reporting any food insecurity from study period T1 (baseline) to study period T3 (month 6), as measured by the Abbreviated Child and Adult Food Security Survey (ACAFSS).	From baseline to 6 months
Proportion of Providers Consenting to Participant Approach	Defined as the number of providers consenting to participant/caregiver approach for study enrollment out of the number of providers contacted to request permission to approach. A positive response from the provider will be required for the study team to approach participant/caregivers.	Up to 9 months per enrollment period
Consent Rate	Defined as the proportion of eligible participants/caregivers approached for consent who are enrolled in the study.	Up to 9 months per enrollment period
Retention	Defined as the proportion of participants who remain enrolled in the study at each study timepoint from study period T1 (baseline) to study period T3 (6 months).	From baseline to 6 months
Utilization Rate of Benefits Assistance	Defined as the number of participants/caregivers requesting assistance with SNAP (Supplemental Nutrition Assistance Program) and/or WIC (Women, Infants, and Children Program) benefits.	Up to 6 months
Intervention Fidelity	Defined as proportion of meal kits delivered, proportion of meal kits prepared, proportion of meal kits consumed, and number of unplanned modifications of intervention delivery of meal kits, kitchen equipment, or gift cards.	Up to 6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Food Insecurity Severity	Change in severity of participant/household food insecurity from study period T1 (baseline) to study period T3 (month 6) will be assessed using number of affirmative responses on the 8-item Abbreviated Child and Adult Food Security Survey; a higher number of affirmative responses indicates lower food security.	From baseline to 6 months

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Investigators: Principal Investigator: Rahela Aziz-Bose, MD, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): April 7, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2028

Study Registration Dates

• First Submitted: September 20, 2024
• First Submitted That Met QC Criteria: September 20, 2024
• First Posted (Actual): September 24, 2024

Study Record Updates

• Last Update Posted (Actual): April 13, 2026
• Last Update Submitted That Met QC Criteria: April 8, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: Childhood Cancer; Cardiovascular Health; Childhood Cancer Survivorship
• Additional Relevant MeSH Terms: Neoplasms
• Other Study ID Numbers: 24-423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Rahela Aziz-Bose (PI) [rahela_aziz-bose@dfci.harvard.edu]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1 year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No