| NCT ID | NCT06283251 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dana-Farber Cancer Institute |
| Condition | Pediatric Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2024-05-15 |
| Primary Completion | 2027-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 40 participants in total. It began in 2024-05-15 with a primary completion date of 2027-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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
Eligibility Criteria
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
Contact & Investigator
Kira Bona, MD, MPH
PRINCIPAL INVESTIGATOR
Dana-Farber Cancer Institute
Frequently Asked Questions
Who can join the NCT06283251 clinical trial?
This trial is open to participants of all sexes, up to 17 Years, studying Pediatric Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06283251 currently recruiting?
Yes, NCT06283251 is actively recruiting participants. Contact the research team at Kira_Bona@dfci.harvard.edu for enrollment information.
Where is the NCT06283251 trial being conducted?
This trial is being conducted at San Francisco, United States, Boston, United States, Boston, United States, New York, United States.
Who is sponsoring the NCT06283251 clinical trial?
NCT06283251 is sponsored by Dana-Farber Cancer Institute. The principal investigator is Kira Bona, MD, MPH at Dana-Farber Cancer Institute. The trial plans to enroll 40 participants.
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