Mobile direct observed therapy as an adherence-improving intervention for pediatric leukemia maintenance therapy
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Abstract
Acute lymphoblastic leukemia (ALL) is the most common malignancy of childhood. Although long-term outcomes have greatly improved over the past several decades, outcomes remain poor for children with relapsed disease. Risk of relapse is significantly reduced with strict adherence to the maintenance phase of therapy, which consists of taking daily oral medication for years. Unfortunately, adherence to maintenance therapy in pediatric ALL patients is widely suboptimal. Although reasons for non-adherence are vast and multifactorial, one of the most common reasons is simple forgetfulness. There is a clear need for a user-friendly, economical, and effective adherence-improving intervention for this population. Interest for adherence-improving interventions is high among caregivers of children with ALL and adolescent patients themselves, particularly for technology-based interventions.
Mobile-direct observed therapy (MDOT) is one such technological intervention that has been explored as a method to optimize medication adherence in patient populations requiring long-term pharmacologic treatment. MDOT utilizes smartphone technology to incorporate the capability to record and upload videos of the user taking their medication, set personalized reminders, and correspond with their healthcare team. Early feasibility studies implementing MDOT have shown promising results in patients taking daily medication for treatment of tuberculosis, asthma, and sickle cell disease. This study aims to explore the feasibility of utilizing MDOT as an adherence-improving intervention in pediatric patients who are in the maintenance therapy phase of treatment for ALL. Patients and caregivers will be recruited from Boston Children’s Hospital, one of the largest pediatric cancer treatment centers in the United States. Following a brief training period on use of the MDOT software, participants will begin a 3-month period of MDOT utilization. At the conclusion of the study, feasibility and acceptability of MDOT in this population will be assessed. Furthermore, with this data, researchers will determine whether 6-mercaptopurine (6MP) adherence ≥ 90% over a 3-month period is attainable with use of the MDOT intervention.
Strict adherence to maintenance therapy is tremendously important in reducing the risk of relapse in pediatric ALL patients. Disease relapse is associated with poor clinical outcomes and poses a significant financial burden to the healthcare system. MDOT could be an effective intervention to improve medication adherence in this population, which will be investigated in this preliminary feasibility study.