RecruitingNot ApplicableNCT06831552

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

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


Sponsor

Dana-Farber Cancer Institute

Enrollment

84 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

Conditions

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


Eligibility

Max Age: 17 Years

Inclusion Criteria9

  • 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 Criteria2

  • Foreign national family receiving care as an Embassy-pay patient.
  • Child or household member receiving SSI

Interventions

BEHAVIORALRISE Intervention

Income-poverty targeted, supportive care intervention that includes direct cash transfers delivered by the Fund for Guaranteed Income, a non-profit organization, along with benefits counseling to discuss the risk of means-tested benefits loss or reduction. Funds will be dispersed to families via debit card or through personal banking, PayPal, or Venmo on a twice monthly basis for a total of twelve disbursements (6-months). Meetings with a benefits counselor will be conducted by the HIPAA-compliant video conference platform, Zoom.


Locations(6)

Connecticut Children's Medical Center

Hartford, Connecticut, United States

Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Seattle Children's Hospital

Seattle, Washington, United States

View Full Details on ClinicalTrials.gov

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NCT06831552


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