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NCT Number: NCT06831552

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

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

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Key information

Conditions

Neuroblastoma High-risk Neuroblastoma Neoplasms Neoplasms by Histologic Type Neoplasms, Germ Cell and Embryonal Neoplasms, Glandular and Epithelial Neoplasms, Nerve Tissue Neoplasms, Neuroepithelial Neuroectodermal Tumors Neuroectodermal Tumors, Primitive Neuroectodermal Tumors, Primitive, Peripheral

Age range

Up to 17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Connecticut Children's Medical Center, Hartford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

RISE intervention

Behavioral

Income-poverty targeted, supportive care intervention that includes direct cash transfers delivered by the Fund for Guaranteed Income, a non-profit organization, along with benefits counseling to discuss the risk of means-tested benefits loss or reduction. Funds will be dispersed to families via debit card or through personal banking, PayPal, or Venmo on a twice monthly basis for a total of twelve disbursements (6-months). Meetings with a benefits counselor will be conducted by the HIPAA-compliant video conference platform, Zoom.

Other names: Pediatric Resource Intervention to Support Equity

Primary outcomes

  1. Household Material Hardship (HMH) Score Reduction Rate

    Time frame: Baseline (T1) and 6-months (end-intervention; T3)

    HMH score reduction rate is defined as the proportion of patients achieving at least 1 domain reduction in (food, housing, utility or transportation insecurity). HMH scores range from 0 to 4, with scores of 0 indicating no hardship (unexposed) and scores of 1-4 indicating the presence of hardship (exposed). Patients who are unexposed to HMH at baseline (HMH score of 0) are excluded from the analysis.

Secondary outcomes

  1. Pediatric-Modified Comprehensive Score for Financial Toxicity (COST)

    Time frame: 3-months (end-of-induction; T2) and 6-months (end-intervention; T3)

    Financial toxicity will be assessed with the 12-item modified COST measure. Each item is rated on a 0-4 scale, yielding a total score range of 0-48, with higher scores indicating better financial well-being. The final COST score will be calculated per established methods. A change of approximately 5 points is considered a minimally important difference (MID), representing a clinically meaningful change in financial toxicity.

  2. Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months

    Time frame: Baseline (T1) and 6-months (end-intervention; T3)

    Psychological distress will be assessed using the 6-item Kessler-6 scale. The scale includes 6 items scored from 0 ('none of the time') to 4 ('all of the time'), yielding a total score ranging from 0 to 24, with higher scores indicating greater psychological distress. A reduction in scores of approximately 2.8 points is considered a minimally important difference (MID), representing a clinically meaningful improvement in psychological distress.

  3. Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months

    Time frame: Baseline (T1) and 6-months (end-intervention; T3)

    The PROMIS Applied Cognition-Abilities short form is an 8-item measure assessing subjective learning and memory, attention and concentration, executive function, and processing speed. Responses are scored on a scale of 1-5, and the total score is converted to a T-score with a mean of 50 and a standard deviation (SD) fixed at 10. Higher scores suggest better perceived cognitive function.

Study contacts

Contact information is provided by the study sponsor or research team.

Kira Bona, MD, MPH

CONTACT

[email protected]

617-632-4688

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

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

Acronym: RISE in HR NBL

Important dates

Study start
2025
Primary completion
2029
Study completion
2029
First posted
Feb 18, 2025
Registry last updated
Feb 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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