RECRUITING

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

Conditions

Childhood Cancer Childhood Cancer Survivors Cardiovascular Health Childhood Cancer Survivorship

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-04-07

Study Completion:2028-02-28

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06609473

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified to 18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD, ADULT

Inclusion Criteria	Exclusion 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.	* Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy; * Foreign national family receiving cancer care as an embassy-pay patient.

Inclusion Criteria

Exclusion 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.

* Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
* Foreign national family receiving cancer care as an embassy-pay patient.

Contacts and Locations

Study Contact

Rahela Aziz-Bose, MD

CONTACT

617-632-3352

rahela_aziz-bose@dfci.harvard.edu

Principal Investigator

Rahela Aziz-Bose, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Study Locations (Sites)

Boston Children's Hospital

Boston, Massachusetts, 02115

United States

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

Rahela Aziz-Bose, MD, PRINCIPAL_INVESTIGATOR, Dana-Farber Cancer Institute

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-04-07

Study Completion Date2028-02-28

Study Record Updates

Study Start Date2025-04-07

Study Completion Date2028-02-28

Terms related to this study

Keywords Provided by Researchers

Cardiovascular Health
Childhood Cancer
Childhood Cancer Survivorship

Additional Relevant MeSH Terms

Childhood Cancer
Childhood Cancer Survivors