PediRISE Feasibility
Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
Dana-Farber Cancer Institute
40 participants
May 15, 2024
INTERVENTIONAL
Conditions
Summary
The goal of this research study is to learn whether investigators can successfully give the PediRISE program to families-in other words, whether most families are interested in participating in a study about the PediRISE program, including a 50-50 chance of receiving standard usual care, and a 50-50 chance of receiving the PediRISE support program. The names of the study groups in this research study are: * PediRISE Program Group * Usual Care Group
Eligibility
Inclusion Criteria16
- Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- Child diagnosed with de novo cancer
- Child has established care at a study site and initiated cancer directed therapy in the prior 2-months
- Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan
- Child is \<18 years at time of enrollment
- Parent/guardian screened positive for self-reported low-income (\<200% FPL)
- Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- Provider approval for permission to approach
- Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- Child undergoing allogeneic HSCT for treatment of cancer
- Child has established care at a study site and is between 30 days prior to start of planned conditioning through day +7 of HSCT at time of enrollment
- Child planned to receive follow-up care after discharge for HSCT at study site
- Child is \<18 years at the time of enrollment
- Parent/guardian screen positive for self-reported low-income (\<200% FPL)
- Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- Provider approval for permission to approach
Exclusion Criteria11
- Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy
- Foreign national family receiving care as an Embassy-pay patient
- Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- Child or household member receiving SSI
- Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF facility for cancer-directed therapy
- Foreign national family receiving care as an Embassy-pay patient
- Child is enrolled on embedded correlative health equity aims of open or upcoming clinical drug trials which are powered on descriptive parent-reported poverty data (e.g. AALL1731, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- Child previously received RISE intervention
- Child or household member receiving SSI
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Interventions
A centrally administered, income-poverty targeted intervention that includes twice-monthly direct provision of unrestricted cash transfers along with benefits counseling to mitigate the risk of loss of means-tested benefits. Funds will be dispersed to families via provided debit card or through personal banking, PayPal, or Venmo.
Locations(4)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06283251