Feasibility of the PediRISE program for families of children with cancer
Pilot Randomized Pediatric RISE (Resource Intervention to Support Equity) Feasibility Study
This study is testing a support program for families of children recently diagnosed with cancer who are struggling financially to see if it helps them better than regular care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | N/A to 17 Years |
| Sex | All |
| Sponsor | Dana-Farber Cancer Institute Academic / other |
| Locations | 4 sites (San Francisco, California and 3 other locations) |
| Trial ID | NCT06283251 on ClinicalTrials.gov |
What this trial studies
This pilot study aims to assess the feasibility of implementing the PediRISE program among families of children newly diagnosed with cancer who are experiencing financial hardship. It involves a randomized approach where participants have an equal chance of receiving either the PediRISE support program or standard usual care. The study will include screening for eligibility, study visits, and the completion of surveys and questionnaires over a period of approximately six months. The target population consists of 40 pediatric participants and their parents or guardians, focusing on those from low-income backgrounds.
Who should consider this trial
Good fit: Ideal candidates are children under 18 years old, recently diagnosed with cancer, and from families with low-income status.
Not a fit: Patients who are not experiencing financial hardship or those enrolled in other specific clinical trials may not benefit from this study.
Why it matters
Potential benefit: If successful, this program could provide essential support to families facing financial stress due to pediatric cancer treatment.
How similar studies have performed: While this approach is novel in its specific focus on financial stress in pediatric cancer care, similar interventions have shown promise in addressing disparities in healthcare access.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
San Francisco, California and 3 other locations
- University of California San Francisco — San Francisco, California, United States (Recruiting)
- Boston Children's Hospital — Boston, Massachusetts, United States (Recruiting)
- Dana Farber Cancer Institute — Boston, Massachusetts, United States (Recruiting)
- Columbia University Medical Center — New York, New York, United States (Recruiting)
Study contacts
- Principal investigator: Kira Bona, MD, MPH — Dana-Farber Cancer Institute
- Study coordinator: Kira Bona, MD, MPH
- Email: Kira_Bona@dfci.harvard.edu
- Phone: 617-632-4688
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.