NCT06323044 MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence
| NCT ID | NCT06323044 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Roswell Park Cancer Institute |
| Condition | Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 150 participants |
| Start Date | 2025-02-11 |
| Primary Completion | 2029-03-31 |
Trial Parameters
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Brief Summary
This clinical trial identifies and addresses barriers to pediatric medication adherence among families of children with acute lymphoblastic leukemia. Pediatric nonadherence (noncompliance) to medication is a significant public health problem, and rigorous research repeatedly documents that nonadherence increases risk for hospitalization, healthcare cost, disease progression, and death. Pediatric acute lymphoblastic leukemia (ALL) patients who miss 5% of 6-mercaptopurine (6-MP) doses within the 2-year 6-MP regimen have a 2.7-fold risk of cancer that comes back after a period of improvement (relapse). To address these families' needs, researchers have developed MedSupport, a theory-based multilevel intervention with targets at the organizational, healthcare team, and caregiver levels that is designed to address root barriers to medication adherence. This study is being done to better understand families' experiences giving their child oral chemotherapy at home and to help families cope with the day-to-day challenges of giving their child medication.
Eligibility Criteria
Inclusion Criteria: * Parent of a child who is diagnosed and receiving first line therapy for acute lymphoblastic leukemia (ALL) at a study site. * Parent's child patient is age 365 days to \< 19 years at time of study entry. * Parent's child patient's therapy must include 6-mercaptopurine (6-MP) administered orally or by nasogastric (NG) tube. * Parent has verbal English, French, or Spanish fluency. * Parent has a smartphone or access to a computer with an Internet connection. * Participant must understand the investigational nature of this study and sign an Independent Ethics Committee/Institutional Review Board approved written informed consent form prior to receiving any study related procedure. Exclusion Criteria: * Parent is unwilling or unable to follow protocol requirements.
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