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

NCT06609473 | Recruiting

• 1 other identifier: 24-423
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Childhood Cancer; Childhood Cancer Survivors

Keywords

Cardiovascular Health; Childhood Cancer; Childhood Cancer Survivorship

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Change in Food Security Status

  From baseline to 6 months

• Proportion of Providers Consenting to Participant Approach

  Up to 9 months per enrollment period

• Consent Rate

  Up to 9 months per enrollment period

• Retention

  From baseline to 6 months

• Utilization Rate of Benefits Assistance

  Up to 6 months

Other Outcomes (1)

• Change in Food Insecurity Severity

  From baseline to 6 months

Study Arms (1)

CHEF Program

EXPERIMENTAL

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

Interventions

CHEF Intervention Program BEHAVIORAL

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.

Also known as: Cardiovascular Health Equity Through Food Program

CHEF Program

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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:
• Among those receiving chemotherapy, any time from start of last planned cycle of chemotherapy until 12 months from completion of chemotherapy;
• 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.

You may not qualify if:

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

Sponsors & Collaborators

• Dana-Farber Cancer Institute: lead

Study Sites (2)

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Officials

• Rahela Aziz-Bose, MD

  Dana-Farber Cancer Institute

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rahela Aziz-Bose, MD

CONTACT

617-632-3352; rahela_aziz-bose@dfci.harvard.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: September 24, 2024
• Study Start: April 7, 2025
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 30, 2028
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (2)