Abstract Purpose: An evaluation of the oral chemotherapy patient education process at one ambulatory cancer center identified a deficit in documentation in the electronic medical record (EMR) of many recommendations from the American Society of Clinical Oncology (ASCO) and Oncology Nursing Society (ONS) chemotherapy administration and safety standards. Aims: The aim of this quality improvement project is to evaluate the effectiveness of the implementation of two newly developed templates into the EMR at one ambulatory cancer center. Process: The project will evaluate effectiveness by comparing the frequency in documentation of 16 key elements pre and post implementation of the two new EMR templates. These 16 elements are recommended by ASCO/ONS to be included in the documentation of a patient education for oral chemotherapy. This project has been approved by both the East Tennessee State University and Ballad Health IRBs. After EMR system access is granted, there will be two chart reviews of patients newly started on oral chemotherapy. The first review will be prior to template implementation, and the other post implementation. Both reviews will abstract the frequency in documentation of the 16 ASCO/ONS elements using a data abstraction tally tool created by the project investigator. Results: Preliminary evaluation is ongoing. Limitations: This project only includes one cancer center, and therefore includes a small sample size. Conclusion: It is projected that by incorporating these national safety standards into the EMR, this will increase compliance and sustainability in the utilization and documentation of national guideline recommendations. Keywords: Oral chemotherapy, adherence

BACKGROUND: Over the past 10 years, molecular-based and targeted therapies in oral forms have emerged and continue to change the landscape of cancer care and care delivery. While cancer treatments traditionally have been administered at the hospital, oral anti-cancer medications (OAM) can be taken by patients at the comfort and convenience of their homes. However, this also creates implications for ensuring that patients take their oral chemotherapies correctly, timely, and safely, all of which can impact outcomes and tolerance. Studies have shown concerning gaps in patients’ knowledge of taking and handling their OAM, including lower rates of adherence. Interventions have largely consisted of a combination of nurse- and pharmacist-led approaches along with the use of various educational and reminder tools. However, few studies have examined the potential of an intervention led by a pharmacist and a medication (patient) navigator. OBJECTIVE: This ongoing pilot study aims to assess the feasibility of the intervention, the impact on patients’ understanding and adherence to their oral anti-cancer medications, and the patient perceptions of the helpfulness of the intervention. METHODS: Patients who were initiating oral chemotherapy were enrolled at Tufts Medical Center Cancer Center, which was the study site for this pilot intervention. Study participants met with the Specialty Pharmacist and Medication Navigator for their initial education session and teach-back using the Oral Agent Teaching Tool (MOATT). They were also given Information Sheets and individualized Calendars for their OAM. The Pharmacist and/or Navigator subsequently followed up with the participants for three more check-ins and educational boosters. Participants completed study measures including the self-reported Adherence Measure, MD Anderson Symptom Inventory, and study evaluation. RESULTS: A total of 37 patients have so far been enrolled in the study and completed their initial education session with the Pharmacist and 33 of those patients completed the Navigator-led booster check-in approximately one week later. These patients are receiving ongoing follow-up for their two remaining check-ins in the study. After the first teach-back with the Pharmacist, patients largely showed sufficient understanding of how to take and handle their medication. This level of understanding was sustained a week later at the Navigator booster. Despite high levels of self-reported adherence, patients showed insufficient understanding of refill logistics. Patients were highly satisfied with the intervention and had found both the check-ins and the educational tools provided useful. CONCLUSION: This Pharmacist- and Navigator-led intervention was found to be feasible to deliver, capable in enhancing patient understanding and adherence to their medications, and helpful to the patients throughout taking their OAM.

Class of 2016 Abstract / Objectives: Patient medication adherence is a basic requirement for treating chronic myelogenous leukemia (CML) with oral tyrosine kinase inhibitors (TKIs). When imatinib adherence rates are less than 80 or 90 percent, major and complete molecular responses, respectively, do not happen. The purpose of this study was to determine the effect of a real-time medication monitoring (RTMM) reminder system adherence program on the medication possession ratio (MPR). Methods: This analytic study was a retrospective cohort study and used data extracted from chart reviews for patients who received services from 2011 to 2015. It was approved by the Institutional Review Board. The study consisted of an intervention group and a control group (50 patients each). MPRs, demographic, descriptive, and categorical variables were summarized using means, standard deviations (SD), and frequencies/percentages. Results: The study population consisted of adult patients (mean age=62.2, SD=2.7, 50% male) treated by Avella Specialty Pharmacy who received imatinib or nilotinib as treatment for CML, gastrointestinal stromal tumors (GIST), or a similar positive Philadelphia chromosome cancer. Only 4% of patients in the intervention group had an < 85% MPR, compared to 46% in the control group (p < 0.001). Conclusions: In those patients who had an MPR of ≥ 85%, the difference between the groups was statistically significant. As past studies have shown, adherence rates greater than 90% have a higher likelihood of a major or complete molecular response and a greatly reduced risk of disease progression.

Les traitements en cancérologie sont soumis au même risque de non-adhérence que les autres traitements ambulatoires au long cours. Ce travail de thèse a pour objectifs : i) d'étudier les facteurs de risque de dis-adhérence ; ii) de développer un programme d'éducation du patient (PEP) permettant d'améliorer l'adhérence des patients. La première étude étudie les facteurs de risque de non adhésion liés à l'interaction avec le système de soin ; les pratiques des oncologues français relatives à la prescription, la surveillance et l'accompagnement des patients ne sont pas suffisantes actuellement pour assurer un bon niveau de sécurité et d'adhérence des patients sous anticancéreux oraux. Les facteurs de risque de non adhésion liés au patient et au traitement sont étudiés dans la deuxième étude, chez des patients traités par capécitabine pour cancer du sein ou du côlon. Les patients actifs avec un niveau éducatif élevé seraient moins adhérents que les 2 autres. L'ensemble des patients sous capécitabine ont des comportements de sur-adhérence qui mettent en péril leur vie à cause des toxicités induites. La troisième étude présente l'évaluation d'un PEP construit selon une méthodologie standardisée. Ce programme démontre une efficacité dans l'amélioration des connaissances des patientes et de la confiance dans le traitement. Cette étude pilote a permis de modifier ce programme pour qu'il soit plus efficace. Identifier les facteurs de risque de non adhérence aux traitements anticancéreux oraux, à l'aide de méthodologies valides et adaptées au contexte, permet de construire des stratégies d'amélioration de l'adhérence ciblées et efficaces, en faisant levier sur ces facteurs / Non-adherence to oral chemotherapies can lead to lowered efficacy and increased risk of adverse events. The objective of this PhD work was twofold : i) to identify dis-adherence risk factors ii) to develop and test the feasibility of a validated, tailored therapeutic educational program with the aim of improving adherence to oral endocrine adjuvant chemotherapy in breast cancer. A survey was carried out to collect information on drug prescription, administration and surveillance, in order to identify non- adherence risk factors related to health professional behaviors : the majority of prescribers followed no standards in prescription writing, safety monitoring, toxicity prevention and patient education. A cohort study was carried out to identify adherence profiles among patients treated with capecitabine, using a mixed method. A profile of low adherence appeared (highly educated patients, with an irregular active life, with occupied relatives) and absolutely all patients showed an over-adherence profile (with a high risk of toxicity). The pilot study assessing the development and the feasibility of an educational program tailored to patients’ needs led to the improvement of the program : an extra session dealing with anxiety was built, and a new recruitment method was developed. Otherwise, the program succeeded in improving knowledge and trust in the treatment. This PhD work succeeded in identifying new dis-adherence risk factors, thanks to qualitative-quantitative methods. Those risk factors were incorporate in the development process of an educational program, in order to tailor it to the targeted population. This method should guarantee the efficacy of the program on patient’s adherence