RISE Intervention for Neuroblastoma

(RISE in HR NBL Trial)

Overseen By Kira Bona, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Foreign national, Receiving SSI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

84 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It seems to focus on supportive care interventions rather than changes to existing cancer treatments.

How does the RISE Intervention treatment for neuroblastoma differ from other treatments?

The RISE Intervention for neuroblastoma is unique because it likely involves novel immunotherapy approaches, which manipulate the immune system to target cancer cells. This includes the use of monoclonal antibodies and potentially gene-modified tumor cells or immune effectors, offering a different mechanism compared to traditional chemotherapy and surgery. ^{1 2 3 4 5}

What is the purpose of this trial?

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

Research Team

Kira Bona, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for low-income children with high-risk neuroblastoma. Specific eligibility criteria are not provided, but typically participants would need to meet certain health conditions and agree to the study's procedures.

Inclusion Criteria

Patient has not yet initiated Induction Cycle 3

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

Exclusion Criteria

Foreign national family receiving care as an Embassy-pay patient

Child or household member receiving SSI

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person or virtual)

Treatment

Participants receive either usual supportive care or usual supportive care plus Pediatric RISE for 6 months

6 months

Orientation visit (in-person, phone, or virtual), follow-up meetings as needed

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• RISE Intervention

Trial Overview The trial is testing if adding Pediatric RISE, a supportive care intervention aimed at helping families in income-poverty, to usual care improves outcomes for these children compared to usual care alone over a period of 6 months.

Participant Groups

Group I: Arm 1: RISE Intervention + Usual Supportive Care Experimental Treatment 1 Intervention

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 II: Arm 2: Usual Supportive Care Active Control 1 Intervention

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

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

References

1. France pubmed.ncbi.nlm.nih.gov

[Immunotherapy of poor-prognosis neuroblastoma in children: from bench to bedside]. [2011]

2. United States pubmed.ncbi.nlm.nih.gov

High-Risk and Relapsed Neuroblastoma: Toward More Cures and Better Outcomes. [2022]

3. Netherlands pubmed.ncbi.nlm.nih.gov

Neuroblastoma: Therapeutic strategies for a clinical enigma. [2013]

4. United States pubmed.ncbi.nlm.nih.gov

New strategies in refractory and recurrent neuroblastoma: translational opportunities to impact patient outcome. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Neuroblastoma. [2023]