NCT06335745

PediCARE Health Equity Intervention in High-Risk Neuroblastoma

A Randomized Phase II Trial Evaluation of the Addition of the Pediatric Cancer Resource Equity (PediCARE) Health Equity Intervention to Usual Supportive Care for Children With Newly Diagnosed High-Risk Neuroblastoma

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Dana-Farber Cancer Institute · Academic / Other
• Sex: All
• Age: 0 Years – 17 Years
• Healthy volunteers: Not accepted

Summary

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. The names of the intervention groups in this research study are: * Usual supportive care * PediCARE + usual supportive care

Detailed description

This is a randomized Phase II trial evaluating the addition of the Pediatric Cancer Resource Equity (PediCARE) health equity intervention to usual supportive care for poverty-exposed children with newly diagnosed high-risk neuroblastoma. Participants will be randomized into one of two groups: Usual Supportive Care vs. PediCARE + Usual Supportive Care. Randomization means a participant is placed into a group by chance. Participation in this research study is expected to last 6-months. It is expected about 130 people will participate in this research study.

Conditions

• Neuroblastoma
• High-risk Neuroblastoma
• Pediatric Cancer
• Disparities
• Financial Stress
• Poverty

Interventions

Type	Name	Description
BEHAVIORAL	PediCARE Intervention	A household material hardship intervention with monthly, direct provision of groceries and transportation. Resources will be centrally administered by the Dana-Farber Cancer Institute study team.

Timeline

• Start date: 2024-09-01
• Primary completion: 2028-09-01
• Completion: 2028-09-01
• First posted: 2024-03-28
• Last updated: 2024-08-05