Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RISE Intervention.
- Who it may be relevant to
- Registry conditions: Neuroblastoma, High-risk Neuroblastoma. Basic parameters: up to 17 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
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
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.
Interventions
- 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-complia
Primary outcome measures
- Household Material Hardship (HMH) Score Reduction Rate [Time frame: Baseline (T1) and 6-months (end-intervention; T3)]
Secondary outcome measures (3)
- Pediatric-Modified Comprehensive Score for Financial Toxicity (COST) [Time frame: 3-months (end-of-induction; T2) and 6-months (end-intervention; T3)]
- Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months [Time frame: Baseline (T1) and 6-months (end-intervention; T3)]
- Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months [Time frame: Baseline (T1) and 6-months (end-intervention; T3)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Supportive care
Study locations
United States · 6 centers
- Connecticut Children's Medical Center — Hartford
- Children's Healthcare of Atlanta — Atlanta
- Dana-Farber Cancer Institute — Boston
- Children's Hospital of Philadelphia — Philadelphia
- University of Texas Southwestern Medical Center — Dallas
- Seattle Children's Hospital — Seattle
Identifiers
NCT: NCT06831552 · 24-600