Resource Intervention to Support Equity (RISE) in High-Risk Neuroblastoma
Purpose
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
Conditions
- Neuroblastoma
- High-risk Neuroblastoma
Eligibility
- Eligible Ages
- Under 17 Years
- Eligible Sex
- All
- Accepts 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
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Supportive Care
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Arm 1: RISE Intervention + Usual Supportive Care |
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and Household Material Hardship (HMH) severity score. Participant parents/guardians will complete: - Orientation visit in-person, by phone, or virtually with survey - Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams - Meeting with a benefits counselor by phone or virtually and follow up meetings if needed - Fixed amount of cash assistance 2x monthly - 3 months survey - 6 month survey |
|
|
No Intervention Arm 2: Usual Supportive Care |
Participants will be randomized in a 1:1 ratio and stratified according to treatment group and HMH severity score. Participant parents/guardians will complete: - Orientation visit in-person, by phone, or virtually with survey - Access to usual supportive oncology care comprised of social workers, resource specialists and/or psychosocial oncology teams - 3 month survey - 6 month survey |
|
Recruiting Locations
Hartford 4835797, Connecticut 4831725 06106
Atlanta 4180439, Georgia 4197000 30329
Boston 4930956, Massachusetts 6254926 03079
Philadelphia 4560349, Pennsylvania 6254927 19104
Dallas 4684888, Texas 4736286 75390
Seattle 5809844, Washington 5815135 98105
More Details
- Status
- Recruiting
- Sponsor
- Dana-Farber Cancer Institute
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.