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Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma

NCT ID: NCT06831552

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-04-30

Study Completion Date

2029-06-01

Brief Summary

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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

Detailed Description

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This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed children participants with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual supportive care or Pediatric RISE plus usual supportive care. Randomization means a participant is placed into a study group by chance.

The research study procedures include screening for eligibility, in-person or virtual appointments, and surveys.

Participation in this research study is expected to last for about 6-months.

It is expected that about 84 participants will take part in this research study.

Conditions

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Neuroblastoma High-risk Neuroblastoma

Keywords

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Neuroblastoma High-risk Neuroblastoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

RISE Intervention

Intervention Type 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.

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pediatric Resource Intervention to Support Equity

Eligibility Criteria

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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
Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Kira Bona, MD, MPH

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Kira Bona, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Children's Healthcare of Atlanta

Atlanta, Georgia, United States

Site Status RECRUITING

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status RECRUITING

Seattle Children's Hospital

Seattle, Washington, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kira Bona, MD, MPH

Role: CONTACT

Phone: 617-632-4688

Email: [email protected]

Facility Contacts

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Thomas Cash, MD

Role: primary

Kira Bona, MD, MPH

Role: primary

Rochelle Bagatell, MD

Role: primary

Puja Umaretiya, MD

Role: primary

Anurekha Hall, MD

Role: primary

Kristine Karvonen, MD

Role: backup

Other Identifiers

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24-600

Identifier Type: -

Identifier Source: org_study_id