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

Last updated: April 7, 2025
Sponsor: Dana-Farber Cancer Institute
Overall Status: Active - Recruiting

Phase

N/A

Condition

Neuroblastoma

Cancer (Pediatric)

Retinoblastoma

Treatment

CHEF Intervention Program

Clinical Study ID

NCT06609473
24-423
  • Ages < 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  • Child is within one of the following time windows:

  1. Among those receiving chemotherapy, any time from start of last planned cycleof chemotherapy until 12 months from completion of chemotherapy;

  2. Among those receiving radiation therapy alone or radiation and surgery, anytime 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 exposureto chest, brain, thoracic spine, or total body);

  • Child is ≤18 years of age at time of enrollment, or over 18 years of age but undermedical guardianship;

  • Parent/guardian screened positive for food insecurity.* *Assessed through validated 2-item food insecurity screen.

Exclusion

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 Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: CHEF Intervention Program
Phase:
Study Start date:
April 07, 2025
Estimated Completion Date:
February 28, 2028

Study 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.

Connect with a study center

  • Boston Children's Hospital

    Boston, Massachusetts 02115
    United States

    Active - Recruiting

  • Dana-Farber Cancer Institute

    Boston, Massachusetts 02215
    United States

    Active - Recruiting

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