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 — BEHAVIORAL
    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.

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 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

Primary Outcome Measure

Household Material Hardship (HMH) Score Reduction Rate [ Time Frame: Baseline (T1) and 6-months (end-intervention; T3) ]

Central Contacts

Locations (6)

FacilityCityStateZIPSite coordinators
Connecticut Children's Medical CenterHartfordConnecticut06106
Andrea Orsey, MD, MSCE
860-545-9630
Children's Healthcare of AtlantaAtlantaGeorgia30329
Thomas Cash, MD
404-785-1200
Dana-Farber Cancer InstituteBostonMassachusetts03079
Kira Bona, MD, MPH
203-464-9417
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Rochelle Bagatell, MD
267-426-9737
University of Texas Southwestern Medical CenterDallasTexas75390
Puja Umaretiya, MD
(214) 456-2382
Seattle Children's HospitalSeattleWashington98105
Anurekha Hall, MD
206-987-2106
Kristine Karvonen, MD

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