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NCT06609473 | RECRUITING | Childhood Cancer

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

Dana-Farber Cancer Institute

Information provided by (Responsible Party):

Rahela Aziz-Bose, MD

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.

Condition or disease

Childhood Cancer

Childhood Cancer Survivors

Intervention/treatment

CHEF Intervention Program

Phase

NA

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
Estimated Enrollment : 17 participants
Masking : NONE
Primary Purpose : SUPPORTIVE_CARE
Official Title : Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
Actual Study Start Date : 2025-04-07
Estimated Primary Completion Date : 2026-06-30
Estimated Study Completion Date : 2028-02-28

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: to 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers:
Criteria
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.
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors

Location Details

NCT06609473

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How to Participate

Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.

Locations

RECRUITING

United States, Massachusetts

Boston Children's Hospital

Boston, Massachusetts, United States, 02115

RECRUITING

United States, Massachusetts

Dana-Farber Cancer Institute

Boston, Massachusetts, United States, 02215