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Background : Despite patient convenience and better tolerability, treatment challenges have become evident compared with conventional chemotherapy. This study evaluated the effects of a patient-centred medication self-management support programme in patients with metastatic breast cancer undergoing oral anticancer treatment. We also evaluated the programme’s effectiveness based on the perceptions of intervention nurses. Methods: This trial was a two-phased mixed-method approach, with a prospective randomised, parallel-group, two-arm, open-label, four-centre study, followed by a qualitative study using a focus-group interview. Eligible participants were 155 patients with metastatic breast cancer who had been newly prescribed an oral chemotherapy or a targeted therapy agent. The intervention group received the patient-centred medication self-management support programme conducted by trained nurses. Primary outcome was adherence to medication at three months after the commencement of oral chemotherapy or target therapy, calculated as Medication Possession Ratio (MPR). Patients were defined as being adherent if MPR was equal to or greater than 90%. Secondary outcomes included the Japanese version of the General Self-Efficacy (GSE) Scale, Functional Assessment of Cancer Therapy-Breast (FACT-B), Kessler 6 (K6), M.D. Anderson Symptom Inventory (symptom severity and symptom interference), and patient satisfaction score.　 Results: Primary outcome (MPR ≥ 0.9 at three months) was not significantly different in the intervention group (59/64 patients: 92%) and control group (54/59 patients: 92%). There was no significant difference in secondary outcomes except for GSE (p = 0.026). In the qualitative study, comments about the intervention programme of 20 participating nurses were positive. They also felt a patient’s enhanced self-efficacy by reassurance or endorsement. Conclusions: The patient-centred medication self-management support programme in patients with metastatic breast cancer undergoing oral anticancer treatment did not improve medication adherence because the adherence rate was high in both groups. Nevertheless, this study offers suggestions to design future studies for optimal adherence to oral medication therapy, including focusing on patients with high risk of non-adherence and the effect of involvement of other healthcare providers.

Background: Proper management of adverse events is crucial for the safe and effective implementation of anticancer drug treatment. Showa University Hospital uses our interview sheet (assessment and risk control [ARC] sheet) for the accurate evaluation of adverse events. On the day of anticancer drug treatment, a nurse conducts a face-to-face interview. As a feature of the ARC sheet, by separately describing the symptoms the day before treatment and the day of treatment and sharing the information on the medical record, it is possible to clearly determine the status of adverse events. In this study, we hypothesized that the usefulness and points for improvement of the ARC sheet would be clarified by using and evaluating a patient questionnaire.Methods: This study included 174 patients (144 at Showa University Hospital (Hatanodai Hospital) and 30 at Showa University Koto Toyosu Hospital (Toyosu Hospital) who underwent pre-examination interviews by nurses and received cancer chemotherapy at the outpatient center of Hatanodai and Toyosu Hospital. In the questionnaire survey, the ARC sheet’s content and quality, respondents’ satisfaction, structural strengths, and points for improvement were evaluated on a five-point scale.Results: The patient questionnaire received responses from 160 participants, including the ARC sheet use group (132 people) and the non-use group (28 people). Unlike the ARC sheet non-use group, the ARC sheet use group recognized that the sheet was useful to understand the adverse events of aphthous ulcers (p = 0.017) and dysgeusia (p = 0.006). In the satisfaction survey questionnaire, there was a high sense of security in the pre-examination interviews by nurses using the ARC sheet.Conclusions: The ARC sheet is considered an effective tool for comprehensively evaluating adverse events. Pre-examination interviews by nurses using ARC sheets accurately determined the adverse events experienced by patients with anxiety and tension due to confrontation with physicians.