Many possible adverse effects, from mild to life threatening, accompany the systemic treatment of cancer patients. Recognition and appropriate action is essential for optimal quality of life of patients. Consequently, patient-reported outcomes have become essential in clinical oncology. The purpose of this study is to involve the patients in ongoing monitoring, recording, and resolution of adverse effects resulting from chemotherapy via a self-developed smartphone application. We aim to assess the effect of this mobile application on improving symptom management and optimising health care usage, thus positively affecting the quality of life of our patients.
We plan to develop a mobile application mPRO Mamma, which includes: symptom reporting module, useful measures and tips for managing adverse events based on intensity of symptoms, cancer-specific educational materials and an option to share collected data with the oncologist. Between December 2017 and June 2018, we plan to enrol 90 patients with early-stage or locally advanced breast cancer who own an Android-based smartphone and are proficient in using mobile applications in the open trial prior to them starting chemotherapy. Pending completion of mPRO Mamma mobile app development, half of the patients will be assigned to the control group. Upon the release of mPRO Mamma, the other half of the patients will be assigned to the experimental group and given access to the app. The primary objective is to determine the effect of using mPRO Mamma on the quality of life, measured by self-report using EORTC QLQ - BR23 and EORTC QLQ-C30 (version 3.0). Assessment will be performed before the first cycle, after 1 week, at the end of the first cycle, and at the end of chemotherapy. The quality of life index scores in each group will be compared to baseline scores. The secondary objectives are to assess the usage of health resources and to build a database of incidences of adverse events related to chemotherapy for breast cancer.
Clinical trial identification
Legal entity responsible for the study
Institute of Oncology Ljubljana, Slovenia.
Has not received any funding.
All authors have declared no conflicts of interest.