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

Dana-Farber Cancer Institute84 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Neuroblastoma High-risk Neuroblastoma

Interventions

RISE InterventionBEHAVIORAL

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.

Eligibility

Sex: ALLMax age: 17 Years

Medical Language ↔ Plain English

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

Locations (6)

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

Outcomes

Primary Outcomes

Household Material Hardship (HMH) Score Reduction Rate

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.

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

Secondary Outcomes

Pediatric-Modified Comprehensive Score for Financial Toxicity (COST)

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.

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

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

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.

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

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

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.

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

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

Overview

Conditions

Interventions

Eligibility

Locations (6)

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts