Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
RISE in HR NBL
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
1 other identifier
interventional
84
1 country
6
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2025
Longer than P75 for not_applicable
6 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 13, 2025
CompletedFirst Posted
Study publicly available on registry
February 18, 2025
CompletedStudy Start
First participant enrolled
April 30, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2029
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2029
February 10, 2026
February 1, 2026
4.1 years
February 13, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Household Material Hardship (HMH) Score Reduction Rate
HMH score reduction rate is defined as the proportion of patients achieving at least 1 domain reduction in (food, housing, utility or transportation insecurity). HMH scores range from 0 to 4, with scores of 0 indicating no hardship (unexposed) and scores of 1-4 indicating the presence of hardship (exposed). Patients who are unexposed to HMH at baseline (HMH score of 0) are excluded from the analysis.
Baseline (T1) and 6-months (end-intervention; T3)
Secondary Outcomes (3)
Pediatric-Modified Comprehensive Score for Financial Toxicity (COST)
3-months (end-of-induction; T2) and 6-months (end-intervention; T3)
Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months
Baseline (T1) and 6-months (end-intervention; T3)
Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months
Baseline (T1) and 6-months (end-intervention; T3)
Study Arms (2)
Arm 1: RISE Intervention + Usual Supportive Care
EXPERIMENTALParticipants will be randomized in a 1:1 ratio and stratified according to treatment group and Household Material Hardship (HMH) severity score. Participant parents/guardians will complete: * Orientation visit in-person, by phone, or virtually with survey * Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams * Meeting with a benefits counselor by phone or virtually and follow up meetings if needed * Fixed amount of cash assistance 2x monthly * 3 months survey * 6 month survey
Arm 2: Usual Supportive Care
NO INTERVENTIONParticipants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity score. Participant parents/guardians will complete: * Orientation visit in-person, by phone, or virtually with survey * Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams * 3 month survey * 6 month survey
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Foreign national family receiving care as an Embassy-pay patient.
- Child or household member receiving SSI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (6)
Connecticut Children's Medical Center
Hartford, Connecticut, 06106, United States
Children's Healthcare of Atlanta
Atlanta, Georgia, 30329, United States
Dana-Farber Cancer Institute
Boston, Massachusetts, 03079, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
University of Texas Southwestern Medical Center
Dallas, Texas, 75390, United States
Seattle Children's Hospital
Seattle, Washington, 98105, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kira Bona, MD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 13, 2025
First Posted
February 18, 2025
Study Start
April 30, 2025
Primary Completion (Estimated)
June 1, 2029
Study Completion (Estimated)
June 1, 2029
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1 year following the date of publication
The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Dr. Kira Bona. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.