SC-N182: A Randomized Phase II Trial Evaluation of the Addition of the Resource Intervention to Support Equity (RISE) to Usual Supportive Care for Children with Newly Diagnosed High-Risk Neuroblastoma
SC-N182: RISE
What is the goal of the study?
Poverty exposed children with high-risk neuroblastoma treated on ANBL0032 and ANBL091 receiving post-consolidation dinutuximab immunotherapy experienced a 25% lower overal survival compared to children unexposed to poverty. Pediatric RISE (Resource Intervention to Support Equity) is an intervention designed to target income poverty by delivering unrestricted cash transfers. RISE has been pilot tested at the Dana Farber Cancer Institute (DFCI 22-635) among 10 children with newly diagnosed cancer and 10 children with advanced cancer, demonstrating a high consent for participation rate (94%), feasibility and acceptability, without loss of means-tested governmental benefits or concerns about loss of benefits, and no challenges with intervention delivery. Additionally, out of the 18 families with baseline household material hardship exposure, 12 had 1 domain reduction in HMH at 3 month follow up. These pilot data lay the foundation for a phase II signal-finding trial to evaluate household material hardship and financial toxicity, parent and child-level outcomes. A randomized phase II multi-center RISE intervention will be conducted among children with high-risk neuroblastoma who have screened positive for low-income status (<200% below the federal poverty level. the rise intervention arm will be 6-months duration and include a benefits counseling session at enrollment and twice a month cash disbursements in addition to standard of care. the control arm will also be 6 months in duration and include routine psychosocial screening referral and supports as per standard of care at the site. participants will conduct a follow up survey at approximately 3 and 6 months post-enrollment. cash disbursement will depend on number of child dependents living in the household and in total for the 6 month duration of the study will be 7200 for 1-2 dependents 9600 for 3-4 dependents and 12000>/=5 dependents).
Who can participate in the study?
Please contact the study team listed below to learn more.