MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence
Roswell Park Cancer Institute
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.
Description
PRIMARY OBJECTIVE: I. To compare the proportion of pediatric ALL patients with 6-mercaptopurine (6-MP) chemotherapy adherence 95% or higher based on Medication Event Monitoring System (MEMS) data collected during the Consolidation II (1st year of therapy) and Continuation (2nd year of therapy) treatment phases in patients randomized to either MedSupport intervention or usual care. EXPLORATORY OBJECTIVES: I. To compare the proportion of pediatric acute lymphoblastic leukemia (ALL) patients with 6-mercaptopurine chemotherapy adherence based on 6-MP metabolite analysis of peripheral blood bios…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
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/Inst…
Interventions
- OtherBest Practice
Receive usual care
- ProcedureBiospecimen Collection
Undergo blood sample collection
- OtherElectronic Health Record Review
Ancillary studies
- OtherInterview
Ancillary studies
- OtherMedical Device Usage and Evaluation
Receive MedSupport intervention
- OtherMedical Device Usage and Evaluation
Use MEMS device
- OtherSurvey Administration
Location
- Roswell Park Cancer InstituteBuffalo, New York