PediRISE Feasibility

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Pediatric Cancer; Financial Stress; Disparities; Financial Hardship
• Intervention / Treatment: Behavioral: PediRISE Resource Program

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.

• Study Type: Interventional
• Enrollment (Estimated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kira Bona, MD, MPH; Phone Number: 617-632-4688; Email: Kira_Bona@dfci.harvard.edu

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Dana Farber Cancer Institute
      • Contact: Kira Bona, MD, MPH; Phone Number: 617-632-4688; Email: Kira_Bona@dfci.harvard.edu
      • Principal Investigator: Kira Bona, MD, MPH
    • Boston, Massachusetts, United States, 02215
      • Boston Children's Hospital
      • Contact: Kira Bona, MD, MPH; Phone Number: 617-632-4688; Email: Kira_Bona@dfci.harvard.edu
      • Principal Investigator: Kira Bona, MD, MPH

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PediRISE Program Group; Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete: Baseline survey in-person, by telephone, or virtually.; PediRISE program orientation with study team member, in-person or virtual.; Optional meeting with certified benefits counselor.; Receive fixed funds twice a month for 6 months.; Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.; End of study survey.	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.; Other Names: PediRISE
No Intervention: Usual Care Group; Participants will be randomized in a 1:1 fashion and will be stratified by site. Participant parents will complete: Baseline survey in-person, by telephone, or virtually, and orientation with study team member.; Standard supportive care from social worker and/or resource specialist to identify and discuss available resources.; End of study survey.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Participant Consent	Feasibility of intervention is defined as >75% of screened participants consent to randomization.	1 Day
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
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

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: American Cancer Society, Inc.; Children's Cancer Research Fund
• Investigators: Principal Investigator: Kira Bona, MD, MPH, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2024
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2024

Study Registration Dates

• First Submitted: February 22, 2024
• First Submitted That Met QC Criteria: February 22, 2024
• First Posted (Actual): February 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 22, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Pediatric Cancer; Disparities; Financial Stress; Financial Hardship
• Additional Relevant MeSH Terms: Behavioral Symptoms; Stress, Psychological; Financial Stress
• Other Study ID Numbers: 23-590

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Dr. Kira Bona. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• IPD Sharing Time Frame: Data can be shared no earlier than 1-year following the date of publication
• IPD Sharing Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No