PediRISE Program for Families Facing Pediatric Cancer

Recruiting at 1 trial location

Overseen By Kira Bona, MD, MPH

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: Dana-Farber Cancer Institute

Disqualifiers: Non-DFCI transfer, Embassy-pay, SSI, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 6 months

40 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Research Team

Kira Bona, MD, MPH

Principal Investigator

Dana-Farber Cancer Institute

Eligibility Criteria

This trial is for families dealing with financial stress due to pediatric cancer. Participants must be interested in a study where they have an equal chance of receiving either standard care or the PediRISE support program, which aims to alleviate financial hardship.

Inclusion Criteria

Provider approval for permission to approach

My child is set to undergo cancer treatment for at least 4 months from diagnosis.

My child was diagnosed with cancer for the first time.

Exclusion Criteria

Child or household member receiving SSI

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)

Foreign national family receiving care as an Embassy-pay patient

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person or virtual)

Treatment

Participants are randomized to either the PediRISE Program Group or Usual Care Group, with activities including surveys, program orientation, and supportive care

6 months

Multiple visits (in-person, telephone, or virtual)

Follow-up

Participants are monitored for completion of the 6-month survey and overall feasibility of the intervention

6 months

Treatment Details

Interventions

• PediRISE Resource Program

Trial Overview The PediRISE Feasibility study is testing the effectiveness of the PediRISE Resource Program compared to usual care in managing financial difficulties associated with pediatric cancer. Families will be randomly assigned to one of two groups: those who receive standard care and those who get additional support from PediRISE.

Participant Groups

Group I: PediRISE Program Group Experimental Treatment 1 Intervention

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.

Group II: Usual Care Group Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Dana-Farber Cancer Institute

Lead Sponsor

Trials

1,128

Recruited

382,000+

American Cancer Society, Inc.

Collaborator

Trials

237

Recruited

110,000+

Children's Cancer Research Fund

Collaborator

Trials

3

Recruited

150+

Children's Cancer Research Fund

Collaborator