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

Not Applicable

Not yet recruiting

• Conditions: Childhood Cancer; Childhood Cancer Survivors
• Interventions: Behavioral: CHEF Intervention Program

• Registration Number: NCT06609473
• Lead Sponsor: Dana-Farber Cancer Institute

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.

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.
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Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Status Verified: 2024-09
• Study First Submitted: 2024-09-20
• Study First Submitted QC: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Submitted: 2024-09-30
• Last Update Posted: 2024-10-01
• Study Start: 2024-12
• Primary Completion: 2026-03-15
• Study Completion: 2027-11-15

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 17

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CHEF Program	CHEF Intervention 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

Primary Outcome Measures

Name	Time	Method
Change in Dietary Quality Score	From baseline to 6 months	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).

Secondary Outcome Measures

Name	Time	Method
Change in Food Security Status	From baseline to 6 months	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).
Proportion of Providers Consenting to Participant Approach	Up to 9 months per enrollment period	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.
Consent Rate	Up to 9 months per enrollment period	Defined as the proportion of eligible participants/caregivers approached for consent who are enrolled in the study.
Retention	From baseline to 6 months	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).
Utilization Rate of Benefits Assistance	Up to 6 months	Defined as the number of participants/caregivers requesting assistance with SNAP (Supplemental Nutrition Assistance Program) and/or WIC (Women, Infants, and Children Program) benefits.
Intervention Fidelity	Up to 6 months	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.

Trial Locations

Locations (2)

Boston Children's Hospital; 🇺🇸 Boston, Massachusetts, United States

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States