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

Status: Recruiting
Location: See all (5) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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

Eligibility
Participation Requirements
Sex: All
Maximum Age: 17
Healthy Volunteers: f
View:

⁃ 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

Locations
United States
Georgia
Children's Healthcare of Atlanta
RECRUITING
Atlanta
Massachusetts
Dana-Farber Cancer Institute
RECRUITING
Boston
Pennsylvania
Children's Hospital of Philadelphia
RECRUITING
Philadelphia
Texas
University of Texas Southwestern Medical Center
RECRUITING
Dallas
Washington
Seattle Children's Hospital
RECRUITING
Seattle
Contact Information
Primary
Kira Bona, MD, MPH
Kira_Bona@dfci.harvard.edu
617-632-4688
Time Frame
Start Date: 2025-04-30
Estimated Completion Date: 2029-06-01
Participants
Target number of participants: 84
Treatments
Experimental: Arm 1: RISE Intervention + Usual Supportive Care
Participants 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
No_intervention: Arm 2: Usual Supportive Care
Participants 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
Sponsors
Leads: Dana-Farber Cancer Institute

This content was sourced from clinicaltrials.gov