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Trial Title:
PediRISE Feasibility
NCT ID:
NCT06283251
Condition:
Pediatric Cancer
Financial Stress
Financial Hardship
Disparities
Conditions: Official terms:
Financial Stress
Conditions: Keywords:
Pediatric Cancer
Financial Stress
Financial Hardship
Disparities
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
PediRISE Resource Program
Description:
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.
Arm group label:
PediRISE Program Group
Other name:
PediRISE
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
Detailed description:
This is a pilot, multi-center, randomized research study for the feasibility of the
administration of the PediRISE program among 40 poverty exposed children with newly
diagnosed cancer. Randomization means there is an equal chance of being assigned to the
PediRISE Program Group or the Usual Care Group.
Study procedures include screening for eligibility, study visits, and completion of
surveys and questionnaires.
Participation in this study will last for about 6-months.
It is expected that about 40 pediatric participants with parents/guardians will take part
in this research study.
This study is being supported by grants from the American Cancer Society and the
Children's Cancer Research Fund.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- 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 MA, NY or NJ
- Provider approval for permission to approach
Exclusion Criteria:
- 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, AHOD2131, ANBL2131, DFCI 23-001).
- Child or household member receiving SSI.
Gender:
All
Minimum age:
N/A
Maximum age:
17 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Boston Children's Hospital
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kira Bona, MD, MPH
Phone:
617-632-4688
Email:
Kira_Bona@dfci.harvard.edu
Investigator:
Last name:
Kira Bona, MD, MPH
Email:
Principal Investigator
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kira Bona, MD, MPH
Phone:
617-632-4688
Email:
Kira_Bona@dfci.harvard.edu
Investigator:
Last name:
Kira Bona, MD, MPH
Email:
Principal Investigator
Start date:
May 15, 2024
Completion date:
December 31, 2024
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
American Cancer Society, Inc.
Agency class:
Other
Collaborator:
Agency:
Children's Cancer Research Fund
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06283251
