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

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.

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.

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.

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.