Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change in Dietary Quality Score
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
- •Foreign national family receiving cancer care as an embassy-pay patient.
研究组 & 干预措施
CHEF Program
Enrolled participants and caregivers will complete:
- Baseline visit and survey
- Meeting with a certified benefits counselor by phone or video teleconference
- Kitchen equipment delivery
- Weekly meal kit deliveries
- Monthly grocery support via gift card
- Second meeting with a certified benefits counselor
- 3-month survey
- Final survey and interview with study staff
干预措施: CHEF Intervention Program (Behavioral)
结局指标
主要结局
Change in Dietary Quality Score
时间窗: 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).
次要结局
- Change in Food Security Status(From baseline to 6 months)
- Proportion of Providers Consenting to Participant Approach(Up to 9 months per enrollment period)
- Consent Rate(Up to 9 months per enrollment period)
- Retention(From baseline to 6 months)
- Utilization Rate of Benefits Assistance(Up to 6 months)
- Intervention Fidelity(Up to 6 months)
研究者
Rahela Aziz-Bose, MD
Principal Investigator
Dana-Farber Cancer Institute