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Standard 4.7 – Study of Quality Endocrine Therapy Compliance Study Topic: Breast cancer is the most common cancer diagnosed among women in the United States with an estimated 232,000 new cases diagnosed annually (DiBonaventura, Copher, Basurto, Faria & Lorenzo 2014). For women with hormone receptor positive early stage breast cancer, they are typically prescribed adjuvant endocrine therapy such as tamoxifen or an aromatase inhibitor for five or more years after definitive locoregional treatment. Endocrine therapy with tamoxifen and/or aromatase inhibitors lowers the risk of breast cancer recurrence and cancer specific mortality. However despite the survival benefit of adjuvant endocrine therapy, its full benefit is often unrealized because some breast cancer patients do not completely adhere to the medication schedule prescribed to them resulting in missed doses. Non adherence may range from ceasing to take a drug to occasionally missing a dose because of forgetfulness. This often results in decreased survival associated with noncompliance of adjuvant endocrine treatment. Adherence may be defined as the extent to which patients take medications as prescribed by their health care providers. It reflects both the willingness and the ability of patients to follow a prescribed treatment plan, daily and throughout the entire course of therapy. No matter how effective a drug may be, its efficacy ultimately depends on the patient’s ability to adhere to the prescribed dosing regimen in the long term. Nonadherence with endocrine therapy is associated with decreased survival. According to Simon, Latreille, Matte, Desjardins and Bergeron (2013), noncompliance or nonadherence is an underappreciated and underreported problem, reaching rates as high as 60% and puts patients at risk of inadequate clinical benefit. Identifying factors associated with patients’ non-compliance to prescribed therapy is essential. The purpose of this project is to determine the cause of noncompliance among our breast cancer patients who are non-adherent to their prescribed endocrine therapy. Study Methodology: A survey was used to gather the data needed. The target population was patients being treated for an estrogen receptor – positive breast cancer with endocrine therapy by our four oncologists. The nurse navigator prepared the survey using the 4-item Morisky Medication Adherence Scale (MMAS). This questionnaire was used because it is the quickest to administer and score. Its closed question format allows disclosures of nonadherence and is able to identify barriers to adherence. The survey was done among patients scheduled for regular follow-up with our four oncologists during a specific period of time. Their current medication list was checked. Patients taking endocrine therapy were identified and were asked to participate in the survey. These patients were informed of the study at the time of their visit. The survey was anonymous with no patient identifier included in the questionnaire. Age was the only demographic information taken. Data gathering was done for 12 days. The participants were asked to identify the endocrine therapy they were prescribed. Adherence was determined by asking if they are taking their pills for their breast cancer. Complete adherence to treatment was defined as 100% medication intake as reported by the patient, and nonadherence was missing or intentionally stopping their medicine. For participants who responded affirmatively to nonadherence, specific reasons were provided and were asked to identify the reasons for doing so. The nurse navigator gathered and compiled the data at the end of the study period. The data collected was used to develop specific interventions that aim to optimize patient adherence to prescribed endocrine treatment. Results: There were 67 patients that qualified to do the survey. Forty-two participated, five declined and the remaining 20 patients either did not show up for their appointments or were missed and were not given the questionnaire. Age range of participants range from 41 to 90 years old with a median age of 63.4 1 Table 1 - Rate of Compliance Number of Patients Percentage 26 16 62% 38% Compliance Never missed With missed doses Table 2 – Reasons for missed doses Number of Patients Percentage 12 4 0 75% 25% 0 Reasons Forgot to take medicine Side effects Financial/schedule difficult to follow/no need for additional treatment/difficulty swallowing pills Out of the 42 patients that participated, 62% said they never missed a dose while 38% had missed doses. Forgetting to take the medicine was the reason 75% of the participants missed their medication while 25% said side effects of the medicine were the reason for not taking it. Findings/Conclusion/Benchmark Comparison: The study showed that within this target population, 62% were compliant with their treatment and only 38% were nonadherent. This represents a fairly good compliance compared with rates reported in the literature. The nonadherence rate to endocrine/hormonal treatment among estrogen receptor positive breast cancer patients is reported to be as high as 60% (Simon et al., 2013). The higher compliance rate could be attributed to the patient population selected to participate in this study. These patients have regular follow-up with their oncologist. Although it was not a goal of this study, the result show that breast cancer patients who are seen regularly in follow-up visits have a higher rate of adherence to hormonal treatment. Consistent follow-up with an oncologist could be one of the main reasons for adherence. For this target population, forgetfulness and side effects are the reasons for nonadherence to endocrine therapy. The result is consistent with Morisky’s perspective based on research that over 50% of patients identify forgetting, or having problems remembering as the main reason for not taking their medication (Morisky & DiMatteo, 2011). It also aligns with the result of a research done by DiBonaventura et al. (2014) that showed forgetfulness and intolerance of side effects were the most common reasons for nonadherence across treatment of all modalities among patients with breast cancer. Side effects such as alopecia, fatigue, neutropenia, neuropathy, nausea and vomiting are among the reported reasons of patients who discontinued endocrine therapy (Hershman, 2016). Because forgetfulness and side effects are among the most frequent reasons for nonadherence, strategies to facilitate compliance should include providing adequate support, frequent monitoring and patient education. This project has its limitations. All data were self-reported and could have been subject to recall biases and other self-presentation effects. However, according to Morisky and DiMatteo (2011) comparing self-report measures of adherence with other approaches (such as pill counts, electronic measures, prescription refills) show that they are not inflated and have generally fared well in adherence measurement. Another limitation is the selection bias of patients who are compliant with follow-ups with their oncologist. The relatively small sample size is another limitation. Actions/Recommendations: Patient education on side effects of endocrine therapy must be done during initial visit and if needed, reinforced during follow-up visits. Patients should know that support is accessible. In addition, the topic of adherence and the potential difficulties in remaining adherent should also be discussed to emphasize its importance. Since provider 2 input and support have been found to affect adherence, good communication between the patient and the health care provider is crucial. To prevent/minimize missed doses due to forgetfulness, patients will be encouraged to use pill reminder systems such as a pill box to remind them of their medication schedule. They are helpful reminder aids especially if nonadherence is unintentional. Alarm features from computers, watch or cellphone can also be used. The use of smartphone medication apps will be offered to patients who might be interested. These are specialized applications that consumers with smart phones can easily download and use. These medication reminder apps include features that can be set for consumption and refills. They proactively deliver reminder systems through traditional means of telecommunication like Short Message Service (SMS) text messaging or emails. The downside to this is that adherence apps can only be used by individuals who have access to a smartphone. This evolving technology may not be available to all patients but it is a viable alternative for a large and growing proportion of the population. Follow-up: The smart phone app MyMedSchedule was offered to some patients. This particular app was selected because it is free and accessible to anyone with a smartphone. The app helps create medication schedules and sends a reminder either by text or email. It has refill reminders to help reorder a prescription. Schedules are easy to create and update. It also has a medication database available that allows the user to enter, search, and select a medication. This app was offered to a small sample of patients who are on endocrine therapy. For those who agreed to try the app, it was downloaded to their phone and their medication schedule was entered. Reminders were set to be sent by text message. Follow-up was done after three days to check if the text messages were helpful as a reminder to take their medication. There was a positive feedback from patients. According to them, the text messages received served as a reminder for them to take their medicine. As a result, there were no missed doses since the app was used. Because of this positive result, the MyMedSchedule app will be offered to patients who might be interested and who will benefit from this type of reminder system. Flyers with information about the app will be placed in the reception desks in the clinic. Patients interested will be assisted in downloading and entering their medication schedule into the app. 3 References: DiBonaventura, M., Copher, R., Basurto, E., Faria, C. & Lorenzo, R. (2014). Patient preferences and treatment adherence among women diagnosed with metastatic breast cancer. American Health & Drug Benefits, 7(7), 386396. Retrieved from www.AHDBonline.com Hershman, D. (Ed.). (2016). Sticking to it: Improving outcomes by increasing adherence [Editorial]. Journal of Clinical Oncology, 1-2. doi:10.1200/JCO.2016.67.7336 Morisky, D. & DiMatteo, R. (2011). Improving the measurement of self-reported medication nonadherence: Response to authors. Journal of Clinical Epidemiology 64(3), 255-263. doi:10.1016/j.jclinepi.2010.09.002 Simon, R., Latreille, J., Matte, C., Desjardins, P. & Bergeron, E. (2014). Adherence to adjuvant endocrine therapy in estrogen receptor-positive breast cancer patients with regular follow-up. Canadian Journal of Surgery 57(1), 26-32. doi:10.1503/cjs.006211 4