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

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

Recruiting
17 years and younger
All
Phase N/A

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Overview

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

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

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

Study details
    Neuroblastoma
    High-risk Neuroblastoma

NCT06831552

Dana-Farber Cancer Institute

15 October 2025

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FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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