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
Conditions
Pediatric Cancer, Financial Stress, Financial Hardship, Disparities
Recruitment Status
Not yet recruiting
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.
Eligibility Criteria
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.
Intervention
Intervention Type
Intervention Name
Behavioral
PediRISE Resource Program
Phase
Not Applicable
Gender
All
Min Age
N/A
Max Age
17 Years
Download Date
February 28, 2024
Principal Investigator
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
Primary Contact Information
Kira_Bona@dfci.harvard.edu
This field has been modified from ClinicalTrials.gov to show a contact specific to Boston Children's.
For more information on this trial, visit clinicaltrials.gov.
Contact
For more information and to contact the study team: