Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-01 @ 8:00 PM
Study NCT ID:
NCT06283251
Status:
RECRUITING
Last Update Posted:
2025-12-24
First Post:
2024-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
PediRISE Feasibility
Sponsor:
Dana-Farber Cancer Institute
Organization:
Study Overview
Official Title:
Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
Status:
RECRUITING
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
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 (1) a new diagnosis of childhood cancer at DFCI and Columbia University and among poverty-exposed families with a child with cancer and (2) receiving hematopoietic stem cell transplant (HSCT) at DFCI, Columbia University, or the University of California - San Francisco (UCSF). 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: