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PediRISE Feasibility

PediRISE Feasibility

Recruiting
17 years and younger
All
Phase N/A

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Overview

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

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.

Eligibility

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.

Study details
    Pediatric Cancer
    Financial Stress
    Financial Hardship
    Disparities

NCT06283251

Dana-Farber Cancer Institute

1 April 2025

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FAQs

Learn more about clinical trials

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A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

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Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

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