Oral self‐management of palbociclib (Ibrance®) using mobile technology protocol

• Published in: Journal of advanced nursing 2021-03, Vol.77 (3), p.1556-1566
• Main Authors: Mazzella Ebstein, Ann M., Barton‐Burke, Margaret, Anthony, Venice, Smith, Andrea, Zhang, Zhigang, Robson, Mark
• Format: Article
• Language: English
• Subjects: Attrition; Breast cancer; Cancer; Cell Phone; Clinical outcomes; Drugs; Feasibility; Health care access; Health care expenditures; Humans; Intervention; medication self‐management; midwives; mobile technology; Nurse led care; Nurses; nursing; Oncology; Oral cancer; Patient satisfaction; Piperazines; Portable computers; Prospective Studies; Pyridines; Quality of Life; Questionnaires; Reminders; Self-Management; Smartphones; Technology; Telemedicine; Text Messaging; Usefulness
• ISSN: 0309-2402; 1365-2648
• DOI: 10.1111/jan.14659

Aim This study will test the feasibility and effectiveness of mobile technology intervention on the patients’ self‐management of oral anticancer medication. Secondary objectives include acceptability, the usefulness of text messages, and satisfaction by participants and nurses. Methods This prospective two‐arm study will recruit patients (N = 220) with metastatic breast cancer and initiating treatment with palbociclib (Ibrance ®). Allowing for attrition, patients will be randomized into the control (N = 100) or intervention (N = 100) group. Unidirectional text message reminders will be sent during the treatment cycle through a secure web application using the patient's smartphone. Self‐reported survey responses will be collected at three time points; at consent, end of treatment cycles, and the follow‐up clinic visit and include a demographic questionnaire, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire, Post study questionnaire and the R‐15 Patient Satisfaction Questionnaire. Nurses providing care for study patients will complete the Adaptation of Stamps Nurse Workload questionnaire. Data will be analysed an intent‐to‐treat analysis comparing the two arms. Study approval was obtained in December 2019 and funded in January 2020. Discussion Smartphones are globally available and have text messaging capability which is increasingly being used as an intervention in healthcare studies. This study will test a low‐cost, nurse‐led intervention that enhances the patient's experience with oral anti‐cancer medications, improves access to care, reduces costs, and improves the satisfaction of nurses caring for oncology patients. Impact Despite the ease of administering oral anti‐cancer medications, oncology patients maynot take them as prescribed and consequently, these factors affect patient outcomes and disease control. Given the importance of taking oral anti‐cancer medications and the difficulties patients experience in achieving it, the effective use of mobile technology interventions can actively engage patients in their care and improve medication self‐management of anticancer treatment regimens. 摘要 目的 本项研究旨在验证移动技术干预对患者口服抗癌药物自我管理的可行性和有效性。次要目的包括可接受性, 短信的有用性, 以及参与者和护士的满意度。 方法 这项前瞻性双臂研究将招募转移性乳腺癌患者 (N=220) , 并开始使用帕博西尼(爱博新®) 进行治疗。考虑到损耗, 患者将被随机分为对照组 (N=100) 或干预组 (N=100) 。在治疗周期内, 将使用患者智能手机的安全web应用程序发送单向短信提醒。将在三个时间点收集自我报告的调查结果: 同意时、治疗周期结束时和随访门诊就诊, 包括人口统计问卷、欧洲癌症研究与治疗组织生活质量调查问卷, 研究后调查问卷和R‐15患者满意度调查问卷。护理研究病人的护士将完成护士工作量调查问卷的改编。