Supportive care intervention for low-income children with high-risk neuroblastoma
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
This study is testing a new supportive care program for low-income children with high-risk neuroblastoma to see if it helps them and their families feel better during treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 84 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 6 sites (Hartford, Connecticut and 5 other locations) |
| Trial ID | NCT06831552 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a novel supportive care intervention called Pediatric RISE, aimed at improving outcomes for low-income children diagnosed with high-risk neuroblastoma. Participants will be randomly assigned to receive either standard supportive care or the Pediatric RISE intervention alongside standard care for a duration of six months. The study will involve screening for eligibility, in-person or virtual appointments, and surveys to assess the impact of the intervention on both parent and child outcomes. Approximately 84 participants are expected to take part in this trial.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 0-17 years who have been newly diagnosed with high-risk neuroblastoma and come from low-income families.
Not a fit: Patients who do not meet the low-income criteria or those who have already initiated Induction Cycle 3 of their treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance the quality of life and health outcomes for low-income children battling high-risk neuroblastoma.
How similar studies have performed: While this approach is innovative, similar supportive care interventions have shown promise in improving outcomes for pediatric cancer patients, suggesting potential for success.
Eligibility criteria
Show full 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
Where this trial is running
Hartford, Connecticut and 5 other locations
- Connecticut Children's Medical Center — Hartford, Connecticut, United States (Recruiting)
- Children's Healthcare of Atlanta — Atlanta, Georgia, United States (Recruiting)
- Dana-Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- University of Texas Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Kira Bona, MD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Kira Bona, MD, MPH
- Email: Kira_Bona@dfci.harvard.edu
- Phone: 617-632-4688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.