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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CHEF Program | Experimental | Enrolled participants and caregivers will complete:
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CHEF Intervention Program | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Dietary Quality Score | 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). | From baseline to 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Food Security Status | 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). | From baseline to 6 months |
| Proportion of Providers Consenting to Participant Approach |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Food Insecurity Severity | Change in severity of participant/household food insecurity from study period T1 (baseline) to study period T3 (month 6) will be assessed using number of affirmative responses on the 8-item Abbreviated Child and Adult Food Security Survey; a higher number of affirmative responses indicates lower food security. | From baseline to 6 months |
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:
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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Rahela Aziz-Bose, MD | Contact | 617-632-3352 | rahela_aziz-bose@dfci.harvard.edu |
| Name | Affiliation | Role |
|---|---|---|
| Rahela Aziz-Bose, MD | Dana-Farber Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boston Children's Hospital | Recruiting | Boston | Massachusetts | 02115 | United States |
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: Rahela Aziz-Bose (PI) [rahela_aziz-bose@dfci.harvard.edu]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
Data can be shared no earlier than 1 year following the date of publication
Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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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. |
| Up to 9 months per enrollment period |
| Consent Rate | Defined as the proportion of eligible participants/caregivers approached for consent who are enrolled in the study. | Up to 9 months per enrollment period |
| Retention | 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). | From baseline to 6 months |
| Utilization Rate of Benefits Assistance | Defined as the number of participants/caregivers requesting assistance with SNAP (Supplemental Nutrition Assistance Program) and/or WIC (Women, Infants, and Children Program) benefits. | Up to 6 months |
| Intervention Fidelity | 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. | Up to 6 months |
| Dana-Farber Cancer Institute | Recruiting | Boston | Massachusetts | 02215 | United States |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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