PediRISE Feasibility
Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
1 other identifier
interventional
40
1 country
4
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2024
Typical duration for not_applicable
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 22, 2024
CompletedFirst Posted
Study publicly available on registry
February 28, 2024
CompletedStudy Start
First participant enrolled
May 15, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2027
February 10, 2026
February 1, 2026
3.1 years
February 22, 2024
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Participant Consent Rate
The proportion of eligible participants who provide informed consent to participate in the randomized guaranteed income intervention.
1 Day
Participant Attrition Rate
The proportion of participants who withdraw from the study, are lost to follow-up, or otherwise do not complete the assigned study procedures.
At 6 months
Study Arms (2)
PediRISE Program Group
EXPERIMENTALParticipants 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.
Usual Care Group
NO INTERVENTIONParticipants 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- 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 CA, CT, MA, ME, NH, NJ, NY or RI
- Provider approval for permission to approach
- Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- Child undergoing allogeneic HSCT for treatment of cancer
- Child has established care at a study site and is between 30 days prior to start of planned conditioning through day +7 of HSCT at time of enrollment
- Child planned to receive follow-up care after discharge for HSCT at study site
- Child is \<18 years at the time of enrollment
- Parent/guardian screen positive for self-reported low-income (\<200% FPL)
- Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI
- +1 more criteria
You may not qualify if:
- Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy
- 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, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- Child or household member receiving SSI
- Cohort 2: Poverty-exposed children with cancer undergoing HSCT
- Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF 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, DFCI 25-001). Co-enrollment on a poverty intervention study would confound the specified endpoints of these open trial correlative studies
- Child previously received RISE intervention
- Child or household member receiving SSI
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- American Cancer Society, Inc.collaborator
- Children's Cancer Research Fundcollaborator
Study Sites (4)
University of California San Francisco
San Francisco, California, 94143, United States
Boston Children's Hospital
Boston, Massachusetts, 02215, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215, United States
Columbia University Medical Center
New York, New York, 10032, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kira Bona, MD, MPH
Dana-Farber Cancer Institute
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
February 22, 2024
First Posted
February 28, 2024
Study Start
May 15, 2024
Primary Completion (Estimated)
June 30, 2027
Study Completion (Estimated)
June 30, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- Data can be shared no earlier than 1-year following the date of publication
- Access Criteria
- Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu
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.