PediCARE Health Equity Intervention in High-Risk Neuroblastoma

Dana-Farber Cancer Institute

Status: Withdrawn

Conditions: High-risk Neuroblastoma; Disparities; Neuroblastoma; Financial Stress; Poverty; Pediatric Cancer

Treatments: Behavioral: PediCARE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06335745

24-066

Details and patient eligibility

About

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

Full 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.

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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0 participants in 2 patient groups

Arm 1: PediCARE + Usual Supportive Care Experimental

Experimental group

Description:

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.

Treatment:

Behavioral: PediCARE Intervention

Arm 2: Usual Supportive Care Arm

No Intervention group

Description:

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