Clinical trial NCT06831552: Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Neuroblastoma
High-risk Neuroblastoma
Keywords: Neuroblastoma
High-risk Neuroblastoma
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
First posted: 2025-02-18
Enrollment: 84
Sex: ALL
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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: 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

Primary outcomes:
measure: Household Material Hardship (HMH) Score
timeFrame: Baseline (T1) and 6-months (end-intervention; T3)
Secondary outcomes:
measure: Pediatric-Modified Comprehensive Score for Financial Toxicity (COST) Score
timeFrame: 3-months (end-of-induction; T2) and 6-months (end-intervention; T3)
measure: Kessler-6 Psychological Distress Scale Score
timeFrame: Baseline (T1) and 6-months (end-intervention; T3)
measure: Patient-Reported Outcomes Measurement Information System (PROMIS) Applied Cognition-Abilities Scale Score
timeFrame: Baseline (T1) and 6-months (end-intervention; T3)
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana-Farber Cancer Institute
state: Massachusetts
Study officials:
affiliation: Dana-Farber Cancer Institute
name: Kira Bona, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: