Background: With the widespread use of orally administered anticancer agents, self-management by cancer\npatients is inevitable, and adherence to medication is becoming the centre of interest in oncology.\nMethods/Design: This mixed-method study is a two-phased approach with a combined quantitative and\nqualitative design. In the first phase, we will conduct a prospective randomised controlled study to assess the\neffects of a nurse-led medication self-management programme for patients receiving oral anticancer treatment.\nPatients with metastatic breast cancer, who have been newly prescribed an oral chemotherapy or a targeted\ntherapy agent will be enrolled in the study. The participants will be randomly assigned to either the medication\nself-management support programme group (intervention group) or the conventional care group (control group).\nThis will be an open-label study; therefore, neither the patients nor the nurses will be blinded. Nurses will provide\npatients in the intervention group with information by using the teach-back method, help patients set a goal based\non their preferences, and solve problems through follow-up counselling. The primary outcome measure is\nadherence to medication, to be measured on the basis of the medication possession ratio (MPR), which is the ratio\nof the number of days of medication supply to the total days at a specified time interval. We hypothesize that the\nintervention group will have an MPR of �90 % that is significantly higher than that of the control group. Secondary\noutcome measures include self-efficacy, quality of life, psychological distress, severity and interference of symptoms,\npatient satisfaction, emergency department visits, and hospital admissions. In the second phase, we will conduct\nfocus-group interviews with intervention nurses, and perform a content analysis to understand their role and\nchallenges these nurses will face in the programme while improving patients� medication adherence.\nDiscussion: The present study will be the first Japanese study to evaluate the effects of medication\nself-management support provided by nurses to patients with metastatic breast cancer who are receiving\noral anticancer treatment. The study is characterised by a unique patient-centred approach aiming to help\npatients manage their medication based on their needs and preferences, with both quantitative and\nqualitative evaluations. The findings will contribute to the facilitation of medication management in cancer\npatients.
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