PediCARE Health Equity Intervention in High-Risk Neuroblastoma
NCT ID: NCT06335745
Last Updated: 2024-08-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
NA
INTERVENTIONAL
2024-09-30
2028-09-30
Brief Summary
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The names of the intervention groups in this research study are:
* Usual supportive care
* PediCARE + usual supportive care
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Detailed Description
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Participants will be randomized into one of two groups: Usual Supportive Care vs. PediCARE + Usual Supportive Care. Randomization means a participant is placed into a group by chance.
Participation in this research study is expected to last 6-months.
It is expected about 130 people will participate in this research study.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Arm 1: PediCARE + Usual Supportive Care Experimental
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and household material hardship (HMH) severity group and participant parents/guardians will complete:
* Remote baseline visit with introduction to PediCARE intervention by central study team
* Parent completion of baseline survey.
* Receipt of monthly PediCARE resource provisions x 6-months.
* Parent completion of 3-month follow-up survey.
* Parent completion of 6-month follow up survey and end of intervention period.
PediCARE Intervention
A household material hardship intervention with monthly, direct provision of groceries and transportation. Resources will be centrally administered by the Dana-Farber Cancer Institute study team.
Arm 2: Usual Supportive Care Arm
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity group and participant parent/guardians will complete:
* Remote baseline visit
* Parent completion of baseline survey.
* Receipt of site-specific routine supportive care x6-month study period
* Parent completion of 3-month follow-up survey
* Parent completion of 6-month follow-up survey
No interventions assigned to this group
Interventions
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PediCARE Intervention
A household material hardship intervention with monthly, direct provision of groceries and transportation. Resources will be centrally administered by the Dana-Farber Cancer Institute study team.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patient must be enrolled on APEC14B1 and must have consented to future contact on APEC14B1.
* Patient must be enrolled on ANBL2131.
* Patient aged 0-17 years at the time of consent to ANBL2131.
* Patient must have opted-in to embedded optional ANBL2131 Household Survey.
* Family screened positive for HMH or low-income on ANBL2131 Household Survey. \*
* Patient has not yet initiated Induction Cycle 3 on ANBL2131.
* Patient being treated at a U.S. site.
* Patients of all languages are eligible to participate.
* Eligibility based on Household Survey will be determined by central study team review. HMH exposure will be operationalized as the report of at least one of the following four concrete resource insecurities: (1) Food insecurity, (2) Housing Insecurity, (3) Utility Insecurity, (4) Transportation Insecurity. Low-income will be defined as reported annual household income of less than 200% federal poverty level (FPL).
Exclusion Criteria
0 Years
17 Years
ALL
No
Sponsors
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Dana-Farber Cancer Institute
OTHER
Responsible Party
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Kira Bona, MD, MPH
Principal Investigator
Principal Investigators
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Kira Bona, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Dana-Farber Cancer Institute
Other Identifiers
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24-066
Identifier Type: -
Identifier Source: org_study_id
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