PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients—study protocol for a randomised controlled trial
Creators: name: Karsten, Maria Margarete
name: Kühn, Friedrich
name: Pross, Therese
name: Blohmer, Jens-Uwe
name: Hage, Anna Maria
name: Fischer, Felix
name: Rose, Matthias
name: Grittner, Ulrike
name: Gebert, Pimrapat
name: Ferencz, Julia
name: Pauler, Luis
name: Breidenbach, Clara
name: Kowalski, Christoph
name: Matthesius, Gregor
name: Seemann, Jannis
name: Lenz, Jennifer
name: Rocabado, Sophia
name: Du Bois, Marlen
name: Straubing, Lars
name: PRO B Steering Board
Publisher: name: Charité - Universitätsmedizin Berlin
Year: 2021
Subjects: subject: Metastatic breast cancer
subject: Patient-reported outcomes
subject: Value-based health care
subject: Personalised medicine
subject: Quality of life
subject: Health apps
subject: ePROs
subject: 600 Technik, Medizin, angewandte Wissenschaften::610 Medizin und Gesundheit::610 Medizin und Gesundheit

description: Background: Despite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease. Methods: This study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. Discussion: Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert.