Japanese Red Cross Kyushu International College of Nursing, 1-1 Asty Munakata-City, Fukuoka-Prefecture, 811-4157, Japan.
Faculty of Nursing and Medical Care, Keio University, 35 Shinanomachi, Shinjuku-ku, Tokyo, 160-8582, Japan.
Eur J Oncol Nurs. 2020 Aug;47:101780. doi: 10.1016/j.ejon.2020.101780. Epub 2020 Jun 14.
Adherence to medication is the most important challenge facing patients receiving oral anticancer treatment. This study aimed to evaluate the effects of a patient-centred medication self-management support programme in patients with metastatic breast cancer undergoing oral anticancer treatment.
This trial was a two-phased mixed-method randomised controlled study. Eligible participants were 155 patients with metastatic breast cancer newly prescribed an oral chemotherapy or 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 treatment, calculated by medication possession ratio (MPR). Secondary outcomes included self-efficacy, functional assessment, psychological distress, symptom severity and symptom interference, and patient satisfaction. After the completion of the intervention study, focus group interviews were conducted among intervention nurses.
Both intervention and control groups maintained more than 90% of MPR and no significant difference was observed in the primary outcome. Regarding secondary outcomes, only general self-efficacy was significantly different in the two groups. In the qualitative study, the intervention nurses perceived improvement in the patients' self-efficacy, ability to anticipate the impact of treatment and adjust to life, and avoidance of loneliness.
A significant effect of the programme was not found in the program because the adherence rate was high in both groups. Improvement in the patients' self-efficacy was observed both quantitatively and qualitatively.
UMIN Clinical Trials Registry (UMIN-CTR), Japan, UMIN000016597. (27 February 2015).
服用药物的依从性是接受口服抗癌治疗的患者面临的最大挑战。本研究旨在评估以患者为中心的药物自我管理支持方案对接受口服抗癌治疗的转移性乳腺癌患者的影响。
这是一项两阶段混合方法随机对照研究。合格的参与者是 155 名新接受口服化疗或靶向治疗药物的转移性乳腺癌患者。干预组接受了由经过培训的护士实施的以患者为中心的药物自我管理支持方案。主要结局是治疗开始后三个月的药物依从性，通过药物占有率（MPR）计算。次要结局包括自我效能感、功能评估、心理困扰、症状严重程度和症状干扰以及患者满意度。干预研究完成后，对干预护士进行了焦点小组访谈。
干预组和对照组的 MPR 均维持在 90%以上，主要结局无显著差异。关于次要结局，只有一般自我效能感在两组之间存在显著差异。在定性研究中，干预护士认为患者的自我效能感、预测治疗影响和调整生活的能力以及避免孤独感有所提高。
由于两组的依从率都很高，因此该方案没有发现显著效果。患者的自我效能感在数量和质量上都有所提高。
UMIN 临床试验注册（UMIN-CTR），日本，UMIN000016597。（2015 年 2 月 27 日）。
