RecruitingNot ApplicableNCT06323044

MedSupport Intervention to Identify and Address Barriers to Pediatric Medication Adherence

MedSupport: A Novel Multilevel Intervention to Identify and Address Barriers to Pediatric Medication Adherence

Sponsor

Roswell Park Cancer Institute

Enrollment

150 participants

Start Date

Feb 11, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia

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

Inclusion Criteria6

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.