Design and implementation of a social cognitive theory-based medication adherence coaching intervention

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ABSTRACT Dr. Benyam Muluneh’s long-term career goal is to become a leading clinician-researcher in oncology by leveraging health behavior theories and implementation science methods to promote adherence, access, and equitable cancer care. This K08 Mentored Research Career Development award (PAR-21-299) is an initial step toward developing his research program as an NIH-funded independent investigator; with this award, he will follow a structured plan, receive expert mentorship, and conduct research in an ideal environment. Oral anticancer (OAC) agents revolutionized treatment of once-fatal malignancies by extending survival and delaying progression; however, success often requires a medication adherence rate >90%. Medication adherence drops from >80-90% in clinical trials (where patients receive adherence support, proactive symptom management, and the study drug is provided free of charge) to ~40% in clinical practice, compromising clinical outcomes. The National Cancer Institute (NCI) recommends cancer centers design and implement health promotion programs (e.g. adherence interventions) guided by health behavior theories, models, and frameworks. Most published adherence interventions lack NCI’s theory-guided approach: they address known barriers (eg. patient education and symptom management) without addressing critical moderators of health behavior (eg. social support, self- efficacy), compromising effectiveness and long-term sustainability. Additionally, many of the existing interventions were piloted in well-resourced academic medical centers and were not adapted to rural and underserved settings. Our team piloted an adherence coaching intervention—consisting of tailored education and barrier mitigation—which increased adherence rates from 48% to 60% in chronic leukemia patients; however, similar to other adherence programs designed by clinicians, our intervention was not optimally effective (adherence <90%) or sustainable beyond the pilot phase. The objective of this proposed study is to enhance the effectiveness and sustainability of our adherence coaching intervention in both urban/academic and rural setting, by integrating social cognitive theory (SCT)—a proven behavioral theory that conceptualizes health behavior through cognitive, environmental, and behavioral influences —with a well-tested planning framework called intervention mapping (IM). We will identify cognitive, behavioral, and environmental determinants of adherence to OACs in both academic/urban and rural settings (aim 1); conduct focus group discussions to adapt our adherence coaching intervention for local contexts (aim 2); and test the refined adherence coaching intervention in a Type I Hybrid Effectiveness-Implementation study (aim 3). Through the following training objectives, Dr. Muluneh will acquire the skills to complete the research aims: gain training and experience in intervention design using health behavior theories (objective 1); gain training and experience designing effectiveness-implementation studies (objective 2); prepare and submit an R01 grant based on findings from the proposed K08 award (objective 3); and gain professional development skills necessary for a successful faculty career (objective 4). This foundational knowledge is necessary to implement and widely disseminate interventions to improve medication adherence in oncology clinical settings.