P. Gebert (Berlin, Germany)
Charité - Universitätsmedizin BerlinAuthor Of 1 Presentation
- M. Karsten (Berlin, Germany)
- T. Pross (Berlin, Germany)
- F. Kühn (Berlin, Germany)
- J. Blohmer (Berlin, Germany)
- M. Rose (Berlin, Germany)
- F. Fischer (Berlin, Germany)
- C. Breidenbach (Berlin, Germany)
- U. Grittner (Berlin, Germany)
- P. Gebert (Berlin, Germany)
- J. Ferencz (Neu-Ulm, Germany)
- L. Pauler (Neu-Ulm, Germany)
- G. Matthesius (Berlin, Germany)
- J. Lenz (Hamburg, Germany)
- J. Rocabado (Hamburg, Germany)
- L. Straubing (Berlin, Germany)
- M. Du Bois (Berlin, Germany)
- C. Kowalski (Berlin, Germany)
131TiP - PRO B - a randomized controlled trial to evaluate the effect of a digital patient-reported outcome monitoring in metastatic breast cancer patients
Abstract
Background
Symptom-monitoring represents a pivotal part in the care of patients with metastatic breast cancer. A possible approach to this is the collection of patient-reported outcomes (PRO) which enable a direct assessment of disease-related burden from the patient’s perspective and without intermediate interpretation by the treating physician. Thereby, PROs can convey a real-time and detailed status of the patient’s health condition and quality of life with little personnel effort by using mobile devices. The aim of PRO B is to investigate the effects of an intensified digital PRO-surveillance on fatigue levels, quality of life and survival of metastatic breast cancer patients.
Trial design
PRO B is a two-arm, multicenter, randomized controlled trial including 1000 patients and over 40 centers across Germany. Patients in the intervention arm are actively monitored for changes of self-reported symptoms. They receive digital PRO-surveys on a weekly basis and will be contacted by their treating physician in case of worsening PRO-values. Patients in the control arm are surveyed only quarterly and deteriorating PRO-scores do not lead to a contact in this group. Primary endpoint is fatigue and secondary endpoints are the number of unplanned hospital admissions and emergency room visits as well as the physical functioning and survival. The project started on 1st October 2020. Patient enrollment is scheduled to begin in April 2021. A recruitment and observation period of 12 months each is planned.
Clinical trial identification
DRKS-ID: DRKS00024015 UTN U1111-1263-4946.
Legal entity responsible for the study
Charité - Universitätsmedizin Berlin.
Funding
Innovationsausschuss beim Gemeinsamen Bundesausschuss, Germany.
Disclosure
All authors have declared no conflicts of interest.