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NCT Number: NCT06609473

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

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.

Recruiting

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Key information

Age range

Up to 18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Boston Children's Hospital, Boston, Massachusetts, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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:
  • 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.

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.

Treatment and study plan

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.

Other names: Cardiovascular Health Equity Through Food Program

Primary outcomes

  1. Change in Dietary Quality Score

    Time frame: 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 outcomes

  1. Change in Food Security Status

    Time frame: 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).

  2. Proportion of Providers Consenting to Participant Approach

    Time frame: 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.

  3. Consent Rate

    Time frame: Up to 9 months per enrollment period

    Defined as the proportion of eligible participants/caregivers approached for consent who are enrolled in the study.

  4. Retention

    Time frame: 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).

  5. Utilization Rate of Benefits Assistance

    Time frame: 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.

  6. Intervention Fidelity

    Time frame: 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.

Other outcomes

  1. Change in Food Insecurity Severity

    Time frame: From baseline to 6 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Rahela Aziz-Bose, MD

CONTACT

[email protected]

617-632-3352

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Acronym: CHEF

Important dates

Study start
2025
Primary completion
2026
Study completion
2028
First posted
Sep 24, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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