Actively Recruiting
A Randomized Phase II Trial of the Resource Intervention to Support Equity (RISE) Added to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma
Led by Dana-Farber Cancer Institute · Updated on 2026-02-10
84
Participants Needed
6
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying whether adding the Pediatric Resource Intervention to Support Equity (Pediatric RISE), a new supportive care program focused on income-poverty, can improve outcomes for low-income children with newly diagnosed high-risk neuroblastoma. This randomized Phase II trial compares usual supportive care alone to usual care plus the Pediatric RISE intervention to see if it helps families facing financial hardship during cancer treatment. Participants will be randomly assigned to one of two groups for six months: usual supportive care alone or usual care plus Pediatric RISE. Pediatric RISE includes twice-monthly cash assistance delivered via debit card or electronic payment, benefits counseling through video calls to discuss potential loss of means-tested benefits, and ongoing support. Usual supportive care involves access to social workers, resource specialists, and psychosocial oncology teams. Both groups complete surveys at orientation, three months, and six months. During the study, parents or guardians will attend orientation visits either in person, by phone, or virtually, and complete surveys to track financial hardship, psychological distress, and cognitive outcomes. Researchers will measure changes in household material hardship scores from baseline to six months as the primary outcome. The study is expected to enroll about 84 participants and last approximately six months per participant, with ongoing monitoring of supportive care impact on families.
CONDITIONS
Brief Title
Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Child diagnosed with high-risk neuroblastoma
- Child aged 0 to 17 years at consent
- Child has started cancer treatment but not yet begun Induction Cycle 3
- Parent or guardian reports low family income (less than 200% Federal Poverty Level)
- Family resides in MA, PA, IL, CA, WA, CT, GA, WI, or OH
- Child receiving treatment at study site with established care
- Participation allowed regardless of language spoken
- Co-enrollment on ANBL2131 or standard care therapy allowed
You will not qualify if you...
- Foreign national family receiving care as an Embassy-pay patient
- Child or household member currently receiving Supplemental Security Income (SSI) benefits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person or virtual)
Duration - 1 day
Participants attend an orientation visit to complete surveys and be randomized to one of two groups for supportive care.
1 orientation visit (in-person, phone, or virtual)
Duration - 6 months
Participants receive either usual supportive care or the RISE intervention which includes cash assistance and benefits counseling, along with usual supportive care.
Twice monthly meetings or contacts for cash disbursement and counseling for 6 months; surveys at 3 months and 6 months
Trial Site Locations
Total: 6 locations
1
Connecticut Children's Medical Center
Hartford, Connecticut, United States, 06106
Actively Recruiting
2
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30329
Actively Recruiting
3
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 03079
Actively Recruiting
4
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
5
University of Texas Southwestern Medical Center
Dallas, Texas, United States, 75390
Actively Recruiting
6
Seattle Children's Hospital
Seattle, Washington, United States, 98105
Actively Recruiting
Research Team
K
Kira Bona, MD, MPH
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
Similar Trials
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here