High-risk Neuroblastoma, Neuroblastoma
Conditions
Keywords
Neuroblastoma, High-risk Neuroblastoma
Brief summary
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
Detailed description
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.
Interventions
BEHAVIORALRISE Intervention
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.
Sponsors
Dana-Farber Cancer Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 17 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Household Material Hardship (HMH) Score Reduction Rate | 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
| Measure | Time frame | Description |
|---|---|---|
| Pediatric-Modified Comprehensive Score for Financial Toxicity (COST) | 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. |
| Parent Psychological Distress (Kessler-6) Score Change from Baseline to 6 Months | 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. |
| Patient-Reported Outcomes Measurement Information System (PROMIS) Cognitive Abilities Score Change from Baseline to 6 Months | 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. |
Countries
United States
Contacts
CONTACTKira Bona, MD, MPH
PRINCIPAL_INVESTIGATORKira Bona, MD, MPH
Dana-Farber Cancer Institute
Outcome results
None listed