Clinical trial · Interventional
PediRISE Feasibility
Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
NCT06283251CI-TRIAL-00102928recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Disparities | — | UNRESOLVED | — |
| Financial Hardship | — | UNRESOLVED | — |
| Financial Stress | — | UNRESOLVED | — |
| Pediatric Cancer | Childhood Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| PediRISE Resource Program | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PediRISE Program Group
- description
- 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.
- interventionNames
- Behavioral: PediRISE Resource Program
- type
- NO_INTERVENTION
- label
- Usual Care Group
- description
- 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.
Primary outcomes (2)
Eligibility
Eligibility (as posted)
- Sex
- All
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy 1. Child diagnosed with de novo cancer 2. Child has established care at a study site and initiated cancer directed therapy in the prior 2-months 3. Child planned to receive at least 4-months of cancer-directed therapy at study site from time of diagnosis per initial cancer treatment plan 4. Child is \<18 years at time of enrollment 5. Parent/guardian screened positive for self-reported low-income (\<200% FPL) 6. Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI 7. Provider approval for permission to approach Cohort 2: Poverty-exposed children with cancer undergoing HSCT 1. Child undergoing allogeneic HSCT for treatment of cancer 2. 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 3. Child planned to receive follow-up care after discharge for HSCT at study site 4. Child is \<18 years at the time of enrollment 5. Parent/guardian screen positive for self-reported low-income (\<200% FPL) 6. Family primary residence in CA, CT, MA, ME, NH, NJ, NY or RI 7. Provider approval for permission to approach Exclusion Criteria Cohort 1: Poverty-exposed children with cancer receiving front-line cancer-directed therapy 1. Planned transfer of child to a non-DFCI or non-Columbia facility for cancer-directed therapy 2. Foreign national family receiving care as an Embassy-pay patient 3. 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 4. Child or household member receiving SSI Cohort 2: Poverty-exposed children with cancer undergoing HSCT 1. Planned transfer of child to a non-DFCI, non-Columbia, or non UCSF facility for cancer-directed therapy 2. Foreign national family receiving care as an Embassy-pay patient 3. 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 4. Child previously received RISE intervention 5. Child or household member receiving SSI
References
Publications (0)
Data not yet available
No reference posted for this study.