What this study is
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
What's being tested
- PediRISE Resource Program
Intervention · BEHAVIORAL
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.
Study details
- Official title
- Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
- Sponsor
- Dana-Farber Cancer Institute
- Conditions
- Pediatric Cancer · Financial Stress · Financial Hardship · Disparities
- Enrolling
- 40 people
- Starts
- 2024-05-15
- Est. completion
- 2027-06-30
- Design
- Open-label, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age Up to 17 YearsSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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
You can't join if
- 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUniversity of California San Francisco
San Francisco, California, United States
- Lena Winestone, MD, MPH · Contact(877) 822-4453lena.winestone@ucsf.edu
RecruitingBoston Children's Hospital
Boston, Massachusetts, United States
- Kira Bona, MD, MPH · Contact617-632-4688Kira_Bona@dfci.harvard.edu
- Kira Bona, MD, MPH · Principal investigator
RecruitingDana Farber Cancer Institute
Boston, Massachusetts, United States
- Kira Bona, MD, MPH · Contact617-632-4688Kira_Bona@dfci.harvard.edu
- Kira Bona, MD, MPH · Principal investigator
RecruitingColumbia University Medical Center
New York, New York, United States
- Justine Kahn, MD · Contact(212) 305-9770jk2034@cumc.columbia.edu
Recruiting
Study team
Sponsor
Dana-Farber Cancer Institute
Study ID 23-590
Principal investigator
Kira Bona, MD, MPH
Dana-Farber Cancer Institute
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.