Supportive care intervention for low-income children with high-risk neuroblastoma

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Reduced chemotherapy and antibody treatment for children with high-risk neuroblastoma

  This study is testing a new, lighter chemotherapy and antibody treatment for children with high-risk neuroblastoma to see if it helps them get better.

  Recruiting Phase 2 Memorial Sloan Kettering Cancer Center · New York, New York · NCT06528496

• Testing a vaccine with beta-glucan for high-risk neuroblastoma patients

  This study is testing a new vaccine combined with a substance called beta-glucan to see if it can help children with high-risk neuroblastoma who are in complete remission.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT06057948

• Neuroblastoma patients' genomic and biological profile study

  This multicenter, prospective study tests profiles from blood, tumor tissue, and bone marrow to understand neuroblastoma in diagnosed, relapsed, or refractory patients.

  Recruiting at 35 sites Istituto Giannina Gaslini · Ancona and 34 other locations · NCT07881172

• Dinutuximab-beta with chemotherapy in newly diagnosed high-risk neuroblastoma

  This pilot study tests whether adding the antibody dinutuximab-beta to standard induction chemotherapy is safe and helps shrink tumors in kids and young adults with newly diagnosed high-risk neuroblastoma.

  Recruiting at 2 sites Phase 1 Chang Gung Memorial Hospital · Taipei, Taiwan and 1 other locations · NCT07688252

• CIML-NK Cells to Treat Neuroblastoma in Relapsed or Refractory Patients

  We’re testing whether donor-derived cytokine-induced memory-like NK cells can be safely given with dinutuximab to kids and young adults whose neuroblastoma has come back or not responded to treatment.

  Recruiting Phase 2 Children's Hospital Medical Center, Cincinnati · Cincinnati, Ohio · NCT07635056

• Becotatug Vedotin for EGFR-positive relapsed, refractory, or metastatic pediatric solid tumors

  This trial will test Becotatug Vedotin, an EGFR-targeted antibody-drug conjugate, to see if it is safe and helps children aged 2–18 with EGFR-positive relapsed, refractory, or metastatic solid tumors.

  Recruiting Phase 1 Sun Yat-sen University · Guangzhou, Guangdong · NCT07584499

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.