RISE Intervention for Neuroblastoma

(RISE in HR NBL Trial)

Recruiting at 4 trial locations

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether adding a special financial support program, known as Pediatric RISE, to usual care can assist families of low-income children with high-risk neuroblastoma. The goal is to improve outcomes for both children and parents by providing additional resources like financial assistance and meetings with benefits counselors. Participants will receive either standard supportive care alone or standard care plus the Pediatric RISE program. The trial seeks families dealing with high-risk neuroblastoma, residing in certain states, and having a low income, defined as below 200% of the Federal Poverty Level. As an unphased trial, it offers families the chance to access potentially beneficial support resources not yet widely available.

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.

What prior data suggests that the RISE Intervention is safe for children with neuroblastoma?

Research has shown that the RISE Intervention, which focuses on reducing income-related stress and providing support, assists families facing high-risk neuroblastoma. Specific safety concerns are minimal because this program emphasizes support rather than introducing a new drug or medical procedure.

Compared to regular supportive care, the RISE Intervention is likely considered safe. Regular supportive care includes assistance from social workers and resource specialists, which families typically find helpful and without known risks. For those considering joining a trial that includes the RISE Intervention, it may be reassuring to know that it serves as an enhanced support system, aiming to ease life for families during challenging times. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the RISE Intervention for neuroblastoma because it takes a comprehensive approach to support families beyond just medical treatment. Unlike standard care, which typically involves medications and traditional hospital support, the RISE Intervention includes financial assistance and personalized benefits counseling. This approach aims to reduce stress and financial hardship for families, which could potentially improve outcomes for children battling neuroblastoma. By addressing both medical and socioeconomic factors, the RISE Intervention offers a holistic strategy that could set a new standard for supportive care in pediatric oncology.

What evidence suggests that the RISE Intervention could be effective for neuroblastoma?

Research shows that the Pediatric RISE program could greatly assist families dealing with high-risk neuroblastoma. In this trial, participants in Arm 1 will receive the RISE Intervention along with usual supportive care, which includes advice on benefits and financial help, potentially reducing family stress. Studies have indicated that poverty can harm health, and RISE aims to help by offering extra support. Early results suggest this approach could improve the well-being of both children with neuroblastoma and their parents. While data collection continues on its direct effects on neuroblastoma, reducing financial stress appears promising for better overall health and quality of life. ^{1 2 3 6 7}

Who Is on the Research Team?

Kira Bona, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06831552

Resource Intervention to Support Equity (RISE) in High- ... This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed ...

2. trials.braintumor.org trials.braintumor.org/trials/NCT06831552

Resource Intervention to Support Equity (RISE) in High-Risk ... This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed ...

3. dana-farber.org dana-farber.org/clinical-trials/24-600

A Randomized Phase II Trial Evaluation of the Addition ... neuroblastoma can improve parent- and child-centered outcomes. Participants will be randomized to receive one of the following for 6-months: - Usual supportive ...

4. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0006497124031495

Pediatric RISE: Development of a Poverty-Targeted Cash ... Evidence-based supportive care interventions targeting poverty in pediatric oncology as a risk factor for outcome disparities are lacking.

5. withpower.com withpower.com/trial/rise-intervention-for-neuroblastoma-207f6

RISE Intervention for Neuroblastoma ... RISE Intervention will have tolerable side effects & efficacy for patients with Neuroblastoma, Neuroblastoma and Neuroblastoma. See if you qualify today!

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7936051/

Survival in Children's Oncology Group Clinical Trials for High ... We examined the association between poverty and event-free survival (EFS) and overall survival (OS) for children with high-risk neuroblastoma treated in ...

7. trialx.com trialx.com/clinical-trials/listings/315045/resource-intervention-to-support-equity-rise-in-high-risk-neuroblastoma/?&radius=50

Resource Intervention to Support Equity (RISE) in High- ... This is a randomized Phase II trial evaluating the addition of the RISE supportive care equity intervention to usual supportive care for poverty-exposed ...