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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: Childhood Cancer Survivors; Childhood Cancer

Treatments: Behavioral: CHEF Intervention Program

Study type: Interventional

Funder types: Other

Identifiers

NCT06609473

24-423

Details and patient eligibility

About

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.

Full 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.

Enrollment: 17 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

CHEF Program

Experimental group

Description:

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

Treatment:

Behavioral: CHEF Intervention Program