Clinical trial · Interventional

PediCARE Health Equity Intervention in High-Risk Neuroblastoma

A Randomized Phase II Trial Evaluation of the Addition of the Pediatric Cancer Resource Equity (PediCARE) Health Equity Intervention to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma

NCT06335745CI-TRIAL-00079462withdrawnN/AClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Why stopped (as posted): Study halted prematurely, prior to enrollment of first participant

Summary

Brief summary (as posted)

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

Conditions (6)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Disparities	—	UNRESOLVED	—
Financial Stress	—	UNRESOLVED	—
High-risk Neuroblastoma	High Risk Neuroblastoma	ONTOLOGY_EXACT	0.98
Neuroblastoma	Neuroblastoma	ONTOLOGY_EXACT	0.90
Pediatric Cancer	Childhood Malignant Neoplasm	ALIAS	0.90
Poverty	—	UNRESOLVED	—

Interventions

Interventions (1)

Intervention	Type	Mapped drug	Match
PediCARE Intervention	Behavioral	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
Arm 1: PediCARE + Usual Supportive Care Experimental
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.
interventionNames
1. Behavioral: PediCARE Intervention
type
NO_INTERVENTION
label
Arm 2: Usual Supportive Care Arm
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

Primary outcomes (1)

Eligibility

Eligibility (as posted)

Sex: All
Minimum age: 0 Years
Maximum age: 17 Years

Show eligibility criteria text

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.

References

Publications (0)

Data not yet available

No reference posted for this study.