Many patients with cancer are prescribed oral chemotherapy agents. A protocol for a study, published in Research in Nursing and Health, is seeking to determine the real-world adherence and clinical success of these therapies.
Researchers from Emory University have proposed an observational study that will assess monthly adherence to tyrosine kinase inhibitors (TKIs) among patients with chronic myeloid leukemia (CML) over the course of 12 months. The follow-up duration was chosen, as it is significant CML and allows for more robust prediction of long-term clinical outcomes.
The investigators will recruit patients from Grady Hospital and Winship Cancer Institute in Atlanta, Georgia. These sites were selected in order to maximize patient diversity. A total of 150 patients will be recruited for the target sample size of 120 and the study will last for up to 4 years.
At baseline, patients will receive a Medication Event Monitoring System (MEMS® cap) which fits directly on their TKI bottle and electronically monitors adherence. Patients will be assessed at 5 in-person visits every 3 months during which time patients will respond to a questionnaire and be assessed for clinical status.
The main goals of the study are to characterize adherence trajectories, determine how side effects or financial status influence adherence, assess how adherence effects clinical outcomes, and explore unique patient perspectives.
The study designers concluded that the information gleaned from this study will allow for better understanding to the real-world usage and adherence to TKIs among patients with CML. In addition, these data will translate to other oral agents used in the non-CML cancer setting.
Yeager KA, Waldrop‐Valverde D, Paul S, et al. Adherence trajectories in oral therapy for chronic myeloid leukemia: Overview of a research protocol. Res Nurs Health. 2020;43:443–452. doi:10.1002/nur.22069