Implementation and Feasibility of Electronic Patient-Reported Outcome (ePRO) Data Entry in the PRAEGNANT Real-Time Advanced and Metastatic Breast Cancer Registry

Abstract

Purpose Patient-reported outcomes (PROs) have been incorporated into clinical trials for many symptoms and medical conditions. A transition from paper-based capture of PROs to electronic PROs (ePROs) has recently started. This study reports on the feasibility of ePRO assessment in a prospective registry including molecular data for patients with advanced breast cancer. Methods As part of the PRAEGNANT network, patients were invited by clinical trial staff, physicians, and nurses to complete three standardized Internet-based questionnaires (EQ 5D 5 L, CES-D and IPAQ). Feasibility was assessed by the staff members who assigned the user accounts by the patients. The completeness of the questionnaires was also assessed. Results Fifteen of 17 patients who were asked agreed to participate to complete the PRO questionnaires (EQ-5D-5L and CES-D). However, the IPAQ (physical activity) questionnaire was only validly completed by 9 patients. Feasibility was ranked better by the physicians and dedicated clinical trial staff than by the nursing staff. Conclusions Incorporating ePRO questionnaires into an advanced breast cancer registry is feasible, and no major hurdles were reported. Involving stakeholders from the start, the application is tailored to the capacities and abilities of both patients and clinical staff. The patientsʼ compliance was better with some questionnaires, but others may present difficulties.

Development and proof-of-concept of a multicenter, patient-centered cancer registry for breast cancer patients with metastatic disease—the “Breast cancer care for patients with metastatic disease” (BRE-4-MED) registry

“…Furthermore, some hospitals were not able to assist participants in downloading the BRE-4-MED APP or online questionnaire due to problems with highly secured firewalls in some hospitals. Wallwiener et al reported similar challenges on usage of electronically PROs in the "Prospective Academic translational research network for the optimization of oncological health care quality in the advanced setting" (PRAEGNANT) registry [9]. The process chosen for record linkage with both established Cancer Registries (Bavaria and Baden-Wuerttemberg) worked out without any problems.…”

“…8 Centre of Early Cancer Detection and Cancer Registration, Bavarian Health and Food Safety Authority, Nürnberg, Germany. 9 Bavarian Health and Food Safety Authority, Munich, Germany. 10 Department of Medical Psychology and Psychotherapy, Medical Sociology and Rehabilitation Sciences, University of Würzburg, Würzburg, Germany.…”

“…Identification of reasons and obstacles of treatment heterogeneity can provide insights on individual-patient and on structural level. The Cancer Registries in Germany provide individual information on diagnosis, therapy, and outcome, but information on patient-reported outcomes (PROs) for MBC patients are lacking [9]. Potential obstacles, which might lead to deviations from guideline recommendations, are only described for patients with early BC but not for patients with MBC in Germany, yet [10,11].…”

Apps und mehr in der Onkologie

“…Ein weiteres Feld, auf dem sich digitale Ansätze für die Onkologie abzeichnen, ist die digitale Verlaufskontrolle unter einer Tumortherapie. Die Sinnhaftigkeit einer Implementierung von elektronisch erhobenen Daten zum "patient-reported outcome" (ePRO) wurde durch zahlreiche Arbeitsgruppen publiziert [7]. Darüber hinaus konnte gezeigt werden, dass digitale Tools einen hohen Stellenwert beim sogenannten Follow-up entfalten können [8,9].…”

Apps and More: Potentials of Digitalization in Breast Medicine

“…The application is implemented in the PRAEGNANT multicenter trial for patient-reported outcome data collection in metastatic breast cancer [7]. Furthermore, patient adoption, even within the age range of over 60 years, has been high [8].…”