Childhood Cancer, Childhood Cancer Survivors
Conditions
Keywords
Cardiovascular Health, Childhood Cancer, Childhood Cancer Survivorship
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.
Interventions
BEHAVIORALCHEF 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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Dietary Quality Score | From baseline to 6 months | The change in mean participant dietary quality from study period T1 (baseline) to study period T3 (month 6), as measured by the Rapid Prime Dietary Quality Score Screener (scored 0-52, higher score indicates higher quality diet). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Food Security Status | From baseline to 6 months | Change in the proportion of participants reporting any food insecurity from study period T1 (baseline) to study period T3 (month 6), as measured by the Abbreviated Child and Adult Food Security Survey (ACAFSS). |
| Proportion of Providers Consenting to Participant Approach | Up to 9 months per enrollment period | Defined as the number of providers consenting to participant/caregiver approach for study enrollment out of the number of providers contacted to request permission to approach. A positive response from the provider will be required for the study team to approach participant/caregivers. |
| Consent Rate | Up to 9 months per enrollment period | Defined as the proportion of eligible participants/caregivers approached for consent who are enrolled in the study. |
| Retention | From baseline to 6 months | Defined as the proportion of participants who remain enrolled in the study at each study timepoint from study period T1 (baseline) to study period T3 (6 months). |
| Utilization Rate of Benefits Assistance | Up to 6 months | Defined as the number of participants/caregivers requesting assistance with SNAP (Supplemental Nutrition Assistance Program) and/or WIC (Women, Infants, and Children Program) benefits. |
| Intervention Fidelity | Up to 6 months | Defined as proportion of meal kits delivered, proportion of meal kits prepared, proportion of meal kits consumed, and number of unplanned modifications of intervention delivery of meal kits, kitchen equipment, or gift cards. |
Countries
United States
Contacts
CONTACTRahela Aziz-Bose, MD
PRINCIPAL_INVESTIGATORRahela Aziz-Bose, MD
Dana-Farber Cancer Institute
Outcome results
None listed