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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
AgeUp to 18
SponsorDana-Farber Cancer Institute

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Child with any primary cancer diagnosis (non-relapsed, non-secondary malignancy) who has received cancer-directed therapy that includes chemotherapy and/or radiation therapy;

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);

Disqualifiers

Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;

Foreign national family receiving cancer care as an embassy-pay patient.

Trial design

Design model

Single group

Treatments tested in this trial

  • 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.

Treatment groups

17 Participants
are divided into 1 treatment group
Group A: CHEF ProgramExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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).

Time frame
From baseline to 6 months

Secondary outcomes

1

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).

Time frame
From baseline to 6 months
2

Proportion of Providers Consenting to Participant Approach

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.

Time frame
Up to 9 months per enrollment period
3

Consent Rate

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

Time frame
Up to 9 months per enrollment period
4

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).

Time frame
From baseline to 6 months

Other outcomes

1

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.

Time frame
From baseline to 6 months

Sponsors and contacts

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