PediRISE Program for Families Facing Pediatric Cancer
Recruiting in Palo Alto (17 mi)
+1 other location
Overseen byKira Bona, MD, MPH
Age: < 18
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Dana-Farber Cancer Institute
No Placebo Group
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
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.
+4 more
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
+1 more
Trial 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
Participant Groups
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.
2Treatment groups
Experimental Treatment
Active Control
Group I: PediRISE Program GroupExperimental Treatment1 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 GroupActive Control1 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.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Boston Children's HospitalBoston, MA
Dana Farber Cancer InstituteBoston, MA
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Who Is Running the Clinical Trial?
Dana-Farber Cancer InstituteLead Sponsor
American Cancer Society, Inc.Collaborator
Children's Cancer Research FundCollaborator