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Trial Title:
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
NCT ID:
NCT06609473
Condition:
Childhood Cancer
Childhood Cancer Survivors
Conditions: Keywords:
Cardiovascular Health
Childhood Cancer
Childhood Cancer Survivorship
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
CHEF Intervention Program
Description:
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.
Arm group label:
CHEF Program
Other name:
Cardiovascular Health Equity Through Food Program
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.
Criteria for 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.
Gender:
All
Minimum age:
N/A
Maximum age:
18 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Boston Children's Hospital
Address:
City:
Boston
Zip:
02115
Country:
United States
Contact:
Last name:
Rahela Aziz-Bose, MD
Phone:
617-632-3352
Email:
Rahela_aziz-bose@dfci.harvard.edu
Contact backup:
Last name:
Rahela Aziz-Bose, MD
Facility:
Name:
Dana-Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Contact:
Last name:
Rahela Aziz-Bose, MD
Phone:
617-632-3352
Email:
Rahela_aziz-bose@dfci.harvard.edu
Contact backup:
Last name:
Rahela Aziz-Bose, MD
Start date:
December 2024
Completion date:
November 15, 2027
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06609473
