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

Study Purpose

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

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Interventional
Eligible Ages	N/A - 17 Years
Gender	All

More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06831552
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.	N/A
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	Dana-Farber Cancer Institute
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Kira Bona, MD, MPH
Principal Investigator Affiliation	Dana-Farber Cancer Institute
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Other
Overall Status	Not yet recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Neuroblastoma, High-risk Neuroblastoma

Additional Details

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.

Arms & Interventions

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

Behavioral: - 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.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Dana-Farber Cancer Institute, Boston, Massachusetts

Status

Address

Dana-Farber Cancer Institute

Boston, Massachusetts, 03079

Site Contact

Kira Bona, MD, MPH

[email protected]

203-464-9417

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