Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: CHEF Intervention Program.
- Who it may be relevant to
- Registry conditions: Childhood Cancer, Childhood Cancer Survivors. Basic parameters: up to 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Interventions
- Behavioral CHEF Intervention Program
Poverty-targeted intervention utilizing direct resource provision of healthy meal kits and groceries, as well as assisted referral and enrollment in government nutrition assistance benefits, SNAP (Supplement Nutrition Assistance Program) and/or WIC (Woman, Infants, and Children Program). Meal kits will be delivered by a commercial meal kit vendor. Grocery gift cards will be delivered via email, mail, or in-person. Kitchen equipment will be delivered to caregiver residence.
Primary outcome measures
- Change in Dietary Quality Score [Time frame: From baseline to 6 months]
Secondary outcome measures (6)
- Change in Food Security Status [Time frame: From baseline to 6 months]
- Proportion of Providers Consenting to Participant Approach [Time frame: Up to 9 months per enrollment period]
- Consent Rate [Time frame: Up to 9 months per enrollment period]
- Retention [Time frame: From baseline to 6 months]
- Utilization Rate of Benefits Assistance [Time frame: Up to 6 months]
- Intervention Fidelity [Time frame: Up to 6 months]
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:
- 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 criteria
- Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
- Foreign national family receiving cancer care as an embassy-pay patient.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 2 centers
- Boston Children's Hospital — Boston
- Dana-Farber Cancer Institute — Boston
Identifiers
NCT: NCT06609473 · 24-423