NCT06831552

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 84 (estimated)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 17 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Neuroblastoma
• High-risk Neuroblastoma

Interventions

Type	Name	Description
BEHAVIORAL	RISE 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.

Timeline

• Start date: 2025-04-30
• Primary completion: 2029-06-01
• Completion: 2029-06-01
• First posted: 2025-02-18
• Last updated: 2026-02-10

Locations

6 sites across 1 country: United States