Clinical trial NCT06609473: Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
Official title: Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Childhood Cancer
Childhood Cancer Survivors
Keywords: Cardiovascular Health
Childhood Cancer
Childhood Cancer Survivorship
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 17
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility 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.

Primary outcomes:
measure: Change in Dietary Quality Score
timeFrame: From baseline to 6 months
Secondary outcomes:
measure: Change in Food Security Status
timeFrame: From baseline to 6 months
measure: Proportion of Providers Consenting to Participant Approach
timeFrame: Up to 9 months per enrollment period
measure: Consent Rate
timeFrame: Up to 9 months per enrollment period
measure: Retention
timeFrame: From baseline to 6 months
measure: Utilization Rate of Benefits Assistance
timeFrame: Up to 6 months
measure: Intervention Fidelity
timeFrame: Up to 6 months
Other outcomes:
measure: Change in Dietary Quality DietID Score
timeFrame: From baseline to 6 months
measure: Change in Food Insecurity Severity
timeFrame: From baseline to 6 months
Locations:
city: Boston
country: United States
facility: Boston Children's Hospital
state: Massachusetts
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Rahela Aziz-Bose, MD
role: PRINCIPAL_INVESTIGATOR
References: