Summary
This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. The names of the intervention groups in this research study are: Usual supportive care PediCARE + usual supportive care
Conditions
Neuroblastoma, High-risk Neuroblastoma, Pediatric Cancer, Disparities, Financial Stress, Poverty
Recruitment Status
Not yet recruiting
Detailed Description
This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. 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.
Eligibility Criteria
Inclusion Criteria:
Patient must have a new diagnosis of high-risk neuroblastoma.
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:
-Patient has transferred to ANBL1531 Arm E.
Intervention
Intervention Type
Intervention Name
Behavioral
PediCARE Intervention
Phase
Not Applicable
Gender
All
Min Age
0 Years
Max Age
17 Years
Download Date
March 28, 2024
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
Kira.Bona@childrens.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: