PediRISE Feasibility
- Conditions
- Pediatric CancerFinancial StressFinancial HardshipDisparities
- Interventions
- Behavioral: PediRISE Resource Program
- Registration Number
- NCT06283251
- Lead Sponsor
- Dana-Farber Cancer Institute
- Brief 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
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 40
- 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
- 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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description PediRISE Program Group PediRISE Resource Program 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.
- Primary Outcome Measures
Name Time Method Rate of Participant Consent 1 Day Feasibility of intervention is defined as \>75% of screened participants consent to randomization.
6-Month Follow Up Rate for Usual Care Group At 6 months Feasibility of the intervention is defined as \<20% of randomized participants who do not complete 6-month survey in Usual Care Group.
6-Month Follow Up Rate for PediRISE Program Group At 6 months Feasibility of the intervention is defined as \<20% of randomized participants who do not complete 6-month survey in PediRiSE Program group.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (2)
Dana Farber Cancer Institute
🇺🇸Boston, Massachusetts, United States
Boston Children's Hospital
🇺🇸Boston, Massachusetts, United States