Status:
RECRUITING
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
Lead Sponsor:
Dana-Farber Cancer Institute
Conditions:
Childhood Cancer
Childhood Cancer Survivors
Eligibility:
All Genders
Up to 18 years
Phase:
NA
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 treatmen...
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 cardiovas...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
- Foreign national family receiving cancer care as an embassy-pay patient.
Key Trial Info
Start Date :
April 7 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2028
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT06609473
Start Date
April 7 2025
End Date
February 28 2028
Last Update
April 9 2025
Active Locations (2)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02115
2
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215