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

摘要 博士Benyam Muluneh的长期职业目标是通过利用健康， 行为理论和实施科学方法，以促进遵守，访问和公平的癌症护理。K08 指导研究职业发展奖（PAR-21-299）是朝着发展他的研究计划的第一步， NIH资助的独立调查员;有了这个奖项，他将遵循结构化计划，接受专家指导， 在理想的环境中进行研究。口服抗癌剂（OAC）彻底改变了对曾经致命的 通过延长生存期和延迟进展来治疗恶性肿瘤;然而，成功通常需要药物依从性 产率> 90%。在临床试验中，药物依从性从>80-90%下降（患者接受依从性支持， 主动症状管理，研究药物免费提供）在临床实践中约为40%， 影响临床结果。国家癌症研究所（NCI）建议癌症中心设计和实施 以健康行为理论、模型和框架为指导的健康促进计划（如坚持干预）。 大多数已发表的依从性干预措施缺乏NCI的理论指导方法：它们解决了已知的障碍（例如，患者 教育和症状管理），而不解决健康行为的关键调节因素（例如，社会支持，自我， 效率），损害有效性和长期可持续性。此外，许多现有的干预措施是 在资源充足的学术医疗中心进行试点，不适合农村和服务不足的环境。我们的团队 试行了一项依从性辅导干预措施--包括量身定制的教育和障碍缓解--增加了 慢性白血病患者的依从率从48%到60%;然而，与其他设计的依从性计划相似， 从临床医生的角度来看，我们的干预措施并不是最佳有效的（依从性<90%），也不是可持续的，超过了试点阶段。的 本研究的目的是提高我们的坚持教练干预的有效性和可持续性 在城市/学术和农村环境中，通过整合社会认知理论（SCT）-一种经过验证的行为理论， 通过认知、环境和行为影响将健康行为概念化--并有经过充分测试的规划 这个框架叫做干预映射（IM）。我们将确定认知，行为和环境的决定因素， 在学术/城市和农村环境中遵守OAC（目标1）;进行焦点小组讨论， 针对当地情况的依从性辅导干预（目标2）;并在一个类型中测试改进的依从性辅导干预 一.混合自动化-实施研究（目标3）。通过以下培训目标，Muluneh博士将 获得完成研究目标的技能：获得使用健康行为进行干预设计的培训和经验 理论（目标1）;获得设计有效性-实施研究的培训和经验（目标2）;准备 并根据拟议的K 08奖（目标3）的结果提交R 01赠款;并获得专业知识 发展成功的教师职业所需的技能（目标4）。这些基础知识对于 实施并广泛传播干预措施，以提高肿瘤临床环境中的药物依从性。

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.