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NCT06831552NARecruiting

Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma

Dana-Farber Cancer Institute

Start Date

4/30/2025

Completion Date

6/1/2029

Summary

The goal of this study is to test if the addition of a novel income-poverty targeted supportive care intervention (Pediatric Resource Intervention to Support Equity \[Pediatric RISE\]) to usual supportive care for low-income children with high-risk neuroblastoma can improve parent- and child-centered outcomes. Participants will be randomized to receive one of the following for 6-months: * Usual supportive care alone or * Usual supportive care plus Pediatric RISE

Detailed Description

This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance. The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys. Participation in this research study is expected to last for about 6-months. It is expected that about 84 participants will take part in this research study.

Eligibility Criteria

Age Range: No minimum to 17 years

Inclusion Criteria: Patient cohort: The randomized Phase II multi-center RISE intervention will be conducted among a population of poverty-exposed children with high-risk neuroblastoma. Poverty will be a priori defined as parent-reported low-income (\<200% Federal Poverty Level). Children receiving treatment for cancer at study sites will serve as the study cohort, with parents/guardians as survey informants and intervention recipients on behalf of their minor children given that parents (not children) typically manage household finances. * Patient newly diagnosed with high-risk neuroblastoma * Patient has established care at study site and initiated cancer-directed therapy * Patient has not yet initiated Induction Cycle 3 * Patient aged 0-17 years at the time of consent * Parent/guardian screened positive for self-reported low-income (\<200% Federal Poverty) \* * Family primary residence in MA, PA, IL, CA, WA, CT, GA, WI and OH * Both patients co-enrolled on ANBL2131 or those receiving standard of care therapy at their center are eligible to participate * Patients of all languages are eligible to participate Exclusion Criteria: * Foreign national family receiving care as an Embassy-pay patient. * Child or household member receiving SSI

Interventions

BEHAVIORAL

RISE Intervention

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Conditions

NeuroblastomaHigh-risk Neuroblastoma

Locations

Connecticut Children's Medical Center

Hartford, Connecticut 06106

United States

Children's Healthcare of Atlanta

Atlanta, Georgia 30329

United States

Dana-Farber Cancer Institute

Boston, Massachusetts 03079

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

University of Texas Southwestern Medical Center

Dallas, Texas 75390

United States

Seattle Children's Hospital

Seattle, Washington 98105

United States