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

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

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.

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