Recruiting

Pediatric RISE

Sponsor:

Dana-Farber Cancer Institute

Code:

NCT06831552

Conditions

Neuroblastoma

High-risk Neuroblastoma

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Interventions

RISE Intervention

Study Details

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

Conditions

Neuroblastoma

High-risk Neuroblastoma

Study ID

NCT06831552

Start date

Apr 30, 2025

Status verified date

Feb, 2026

Completion date

Jun 1, 2029

Anticipated

Primary completion date

Jun 1, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 17

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

  • Foreign national family receiving care as an Embassy-pay patient.
  • Child or household member receiving SSI

Study Design

Enrollment

84 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

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

Interventions

RISE Intervention

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.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Kira Bona, MD, MPH

617-632-4688Kira_Bona@dfci.harvard.edu

Locations

Connecticut Children's Medical Center

Recruiting

Hartford, Connecticut, United States, 06106

Contacts

Andrea Orsey, MD, MSCE

860-545-9630aorsey@connecticutchildrens.org

Children's Healthcare of Atlanta

Recruiting

Atlanta, Georgia, United States, 30329

Contacts

Thomas Cash, MD

404-785-1200william.cash@choa.org

Dana-Farber Cancer Institute

Recruiting

Boston, Massachusetts, United States, 03079

Contacts

Kira Bona, MD, MPH

203-464-9417kira.bona@childrens.harvard.edu

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Rochelle Bagatell, MD

267-426-9737bagatellr@chop.edu

University of Texas Southwestern Medical Center

Recruiting

Dallas, Texas, United States, 75390

Contacts

Puja Umaretiya, MD

(214) 456-2382puja.umaretiya@utsouthwestern.edu

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

Contacts

Anurekha Hall, MD

206-987-2106anurekha.hall@seattlechildrens.org

Kristine Karvonen, MD

Kristine.Karvonen@seattlechildrens.org

More Information

Sponsor

Dana-Farber Cancer Institute

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Neuroblastoma
  • High-risk Neuroblastoma

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Dana-Farber Cancer Institute on 2026-02-10.