Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
Part of paid clinical trials in Hartford, Connecticut.
- Sponsor
- Dana-Farber Cancer Institute
- Study ID
- NCT06831552
- Status
- Recruiting
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- N/A - 17 Years
- Healthy Volunteers
- Not accepted
Interventions
- RISE Intervention — BEHAVIORALIncome-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.
Study Details
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
Key Dates
- Start date
- Apr 30, 2025
- Status verified
- Feb 2026
- Primary completion
- Jun 1, 2029
- Completion
- Jun 1, 2029
Study Design
- Enrollment
- 84 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm 1: RISE Intervention + Usual Supportive CareParticipants 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 CareParticipants 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
Primary Outcome Measure
Household Material Hardship (HMH) Score Reduction Rate [ Time Frame: Baseline (T1) and 6-months (end-intervention; T3) ]
Central Contacts
- Kira Bona, MD, MPH617-632-4688
Locations (6)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Connecticut Children's Medical Center | Hartford | Connecticut | 06106 | |
| Children's Healthcare of Atlanta | Atlanta | Georgia | 30329 | |
| Dana-Farber Cancer Institute | Boston | Massachusetts | 03079 | |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | 19104 | |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | |
| Seattle Children's Hospital | Seattle | Washington | 98105 | Kristine Karvonen, MD |
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