A randomized longitudinal intervention study to assess the efficacy and feasibility of telehealth-based strategies to increase oral chemotherapeutic agent medication adherence and health literacy among cancer patients in rural Eastern North Carolina.
Grant
Overview
abstract
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Oral chemotherapeutic agents (OCAs) are increasingly being used as an alternative to traditional intravenous chemotherapy, and factors promoting this trend include increased survival times requiring long-term therapy, acceptability among patients, convenience, and cost savings due to reduced hospital time. Although OCAs are commonly preferred by patients, adherence to these medications vary. Suboptimal medication adherence leads to loss of treatment efficacy, increased toxicity, and increased health care costs. Thus, it is critical to develop and test interventions that effectively improve adherence to OCAs. Although the medication adherence literature has been criticized for methodological issues, some components of interventions have had promising results on adherence such as electronic monitored adherence feedback, cognitive-education, nurse-based interventions, and technology-based or telehealth strategies. We propose to unify components of these effective approaches in a novel way to assess the efficacy and feasibility of two telehealth-based strategies (electronic medication-event monitoring with feedback and tailored nurse coaching which includes cognitive-education) in an effort increase OCA adherence among cancer patients who are at high-risk for non-adherence in rural eastern North Carolina. Using the three-stage process of elicitation, intervention, and evaluation, we first aim to assess the barriers to, and facilitators of, adherence to OCAs among this population. This formative qualitative assessment will be accomplished by conducting interviews/focus groups with cancer patients (n=25-30) and through key informant interviews with health care providers (n=17). Specific aim 2 will test the effectiveness of two telehealth adherence motivation strategies among cancer patients on OCAs who are at high-risk of non-adherence. Guided by the Information-Motivation-Behavioral Skills Model of Adherence and results from formative qualitative assessments, we will conduct a randomized multi-arm intervention study with 150 participants involving two intervention arms and a control (50 participants per arm). Intervention Arm 1 will receive a Medication Event Monitoring System (MEMs) with feedback. Intervention Arm 2 will receive the MEMS plus a tailored nurse coaching component. Controls will receive standard-of-care. Specifically, we want to test whether the tailored nurse coaching will improve medication adherence at significantly higher rates as compared to MEMs-with feedback alone. The nurse coaching will involve an individualized assessment and regular contact with cancer patients via telephone across a six-month period. We hypothesize that although both telehealth strategies will be effective at increasing medication adherence, Arm 2 will have a significantly greater effect. At the core, this study tests innovative approaches in a methodologically sound way that will help to understand what type of intervention may deliver the biggest impact in medication adherence to OCAs for cancer patients. Most importantly, developing and implementing evidence-based strategies for medication adherence can ultimately improve the overall survival and life expectancy of cancer patients.
date/time interval
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November 2019 - October 2020
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