Childhood CancerCHEFNCT06609473
Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
A study testing CHEF Intervention Program in people with Childhood Cancer and Childhood Cancer Survivors, run by Dana-Farber Cancer Institute at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Childhood Cancer, Childhood Cancer Survivors
- What is being tested?
- CHEF Intervention Program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 2 sitesUnited States
- Study dates
- 7 Apr 2025to 15 Jun 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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.
Who cannot join
- Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
- Foreign national family receiving cancer care as an embassy-pay patient.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
United States2 sites, 2 recruiting
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Rahela Aziz-Bose, MD, 617-632-3352, Rahela_aziz-bose@dfci.harvard.edu
Rahela Aziz-Bose, MD
- Recruiting
Dana-Farber Cancer Institute
Boston, Massachusetts, 02215
Rahela Aziz-Bose, MD, 617-632-3352, Rahela_aziz-bose@dfci.harvard.edu
Rahela Aziz-Bose, MD
About this study
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.
Read the detailed description
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.
- Conditions
- Childhood Cancer, Childhood Cancer Survivors
- Being tested
- CHEF Intervention Program
- Keywords
- Cardiovascular Health, Childhood Cancer, Childhood Cancer Survivorship
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHEF Intervention ProgramBehavioural
Also called Cardiovascular Health Equity Through Food 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.
| Study group | Role | What they receive |
|---|---|---|
| CHEF Program | Experimental | 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 Receives: Behavioral: CHEF Intervention Program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: From baseline to 6 months
Secondary outcomes (6)
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).
Measured: From baseline to 6 months
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.
Measured: 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.
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2024
- Study start7 Apr 2025
- Primary completion15 Jan 2027 (estimated)
- Study completion15 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Childhood CancerStudies of the same condition, open and under way.
- More trials run by Dana-Farber Cancer InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dana-Farber Cancer Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rahela Aziz-Bose, MD, Dana-Farber Cancer Institute
- Investigators
- Rahela Aziz-Bose, MD, Principal investigator, Dana-Farber Cancer Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06609473
- Sponsor's protocol ID
- 24-423
- Acronym
- CHEF
- Status last verified
- Sep 2026
- First submitted
- 20 Sep 2024
- Last updated
- 16 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proof-of-Concept Testing of the Cardiovascular Health Equity Through Food (CHEF) Intervention in Childhood Cancer Survivors
- ClinicalTrials.gov ID
- NCT06609473
- Acronym / sponsor ID
- CHEF / 24-423
- Conditions
- Childhood Cancer, Childhood Cancer Survivors
- Keywords
- Cardiovascular Health, Childhood Cancer, Childhood Cancer Survivorship
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Dana-Farber Cancer InstituteUniversity, hospital or other
- Study start
- 7 Apr 2025 (actual)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 15 Jun 2028 (estimated)
- First posted
- 24 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CHEF Program | Experimental | Behavioral: CHEF Intervention ProgramEnrolled 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 |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (2 listed)
- Patient received only surgery, or watchful waiting/surveillance, for cancer- directed therapy;
- Foreign national family receiving cancer care as an embassy-pay patient.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHEF Intervention ProgramAlso: Cardiovascular Health Equity Through Food ProgramPoverty-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. | Behavioural | CHEF Program |
Primary outcome
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).
6 secondary outcomes
Change in Food Security Status
Time frame: From baseline to 6 months
Proportion of Providers Consenting to Participant Approach
Time frame: Up to 9 months per enrollment period
Consent Rate
Time frame: Up to 9 months per enrollment period
Retention
Time frame: From baseline to 6 months
Utilization Rate of Benefits Assistance
Time frame: Up to 6 months
Intervention Fidelity
Time frame: Up to 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2026.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Rahela Aziz-Bose, MD principal investigator
Dana-Farber Cancer Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CHEF Intervention Program in people with Childhood Cancer and Childhood Cancer Survivors, run by Dana-Farber Cancer Institute at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rahela Aziz-Bose, MD (617-632-3352, rahela_aziz-bose@dfci.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Dietary Quality Score (time frame: From baseline to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Sep 2026.