PediRISE Feasibility

Recruiting now · Not applicable

Conditions studied: Pediatric Cancer, Financial Stress, Financial Hardship, Disparities

In brief

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

Key facts

Study ID

NCT06283251

Run by

Dana-Farber Cancer Institute

People needed

40

Starts

2024-05-15

Expected to finish

2027-06-30

Last updated by the study team

2026-02-10

Who can join

Age: any, up to 17. Sex: any. Healthy volunteers: not accepted.

You 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 may not qualify 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

Where it is running

• University of California San Francisco — San Francisco, California, United States (enrolling)
• Boston Children's Hospital — Boston, Massachusetts, United States (enrolling)
• Dana Farber Cancer Institute — Boston, Massachusetts, United States (enrolling)
• Columbia University Medical Center — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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