Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors

Обзор

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.

Подробное описание

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.

Вмешательства

• Поведенческое 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.

Первичные конечные точки

• Change in Dietary Quality Score [Срок оценки: From baseline to 6 months]

Вторичные конечные точки (6)

• Change in Food Security Status [Срок оценки: From baseline to 6 months]
• Proportion of Providers Consenting to Participant Approach [Срок оценки: Up to 9 months per enrollment period]
• Consent Rate [Срок оценки: Up to 9 months per enrollment period]
• Retention [Срок оценки: From baseline to 6 months]
• Utilization Rate of Benefits Assistance [Срок оценки: Up to 6 months]
• Intervention Fidelity [Срок оценки: Up to 6 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
• Foreign national family receiving cancer care as an embassy-pay patient.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Поддерживающая терапия

Центры проведения

США · 2 центра

• Boston Children's Hospital — Boston
• Dana-Farber Cancer Institute — Boston

Идентификаторы

NCT: NCT06609473 · 24-423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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