PediRISE Feasibility

Pediatric Cancer Clinical Trial

Official title:

Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06283251
• Other study ID #: 23-590
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 2024
• Est. completion date: December 31, 2024

Study information

• Verified date: February 2024
• Source: Dana-Farber Cancer Institute
• Contact: Kira Bona, MD, MPH
• Phone: 617-632-4688
• Email: Kira_Bona[@]dfci.harvard.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 17 Years

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.

Related Conditions & MeSH terms

• Disparities
• Financial Stress
• Pediatric Cancer

Intervention

Behavioral:
• PediRISE Resource Program
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.

Locations

Country	Name	City	State
United States	Boston Children's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	American Cancer Society, Inc., Children's Cancer Research Fund

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of Participant Consent	Feasibility of intervention is defined as >75% of screened participants consent to randomization.	1 Day
Primary	6-Month Follow Up Rate for PediRISE Program Group	Feasibility of the intervention is defined as <20% of randomized participants who do not complete 6-month survey in PediRiSE Program group.	At 6 months
Primary	6-Month Follow Up Rate for Usual Care Group	Feasibility of the intervention is defined as <20% of randomized participants who do not complete 6-month survey in Usual Care Group.	At 6 months