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 mean change in 6-mercaptopurine chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2) between pediatric patients with ALL randomized to MedSupport intervention versus usual care \- To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 12 months (T3) between pediatric patients with ALL randomized to MedSupport intervention versus usual care SECONDARY OBJECTIVES; * To compare the mean change in 6MP chemotherapy adherence as assessed by the MEMS from baseline (T1) to 6 months (T2…
Eligibility
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * Parent of a child diagnosed with acute lymphoblastic leukemia (ALL) * Child patient 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. * Verbal fluency in English, or Spanish * Parent has a smartphone or computer access 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…
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