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

Dana-Farber Cancer Institute

Status: Enrolling

Conditions: High-risk Neuroblastoma; Neuroblastoma

Treatments: Behavioral: RISE Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06831552

24-600

Details and patient eligibility

About

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

Full description

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.

Enrollment: 84 estimated patients

Sex: All

Ages: Under 17 years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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84 participants in 2 patient groups

Arm 1: RISE Intervention + Usual Supportive Care

Experimental group

Description:

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

Treatment:

Behavioral: RISE Intervention

Arm 2: Usual Supportive Care

No Intervention group

Description:

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