Abstract P3-11-05: Reliability and acceptance of e-based survey instruments for measuring patient reported outcomes (PRO) in breast cancer patients: First results of the ePROCOM study
Authors: Wallwiener M , Simoes E , Hartkopf AD , Taran F-A , Keilmann L , Sickenberger N , Stevanovic S , Belleville E , Ladra C , Schneeweiss A , Wallwiener D , Brucker SY , Graf J 
Published: March 2017

Abstract
Introduction
Especially in oncology patients, Patient Reported Outcomes (PRO) play an increasingly important role to measure subjectively perceived health status and treatment effects. At the moment, paper-based surveys of PRO still predominate (pPRO); in recent years, data on patient-relevant endpoints is being increasingly collected electronically (ePRO). The aim of the study was to analyze the acceptance of an ePRO-survey tool in breast cancer patients within the PRAEGNANT multicenter trial. Furthermore, it should be considered, whether differences in response behavior between pPRO and ePRO can be identified (reliability check).
Materials and Methods
ePROCOM (Patient Reported Outcomes and Compliance Anaysis) was conceptualized as a monocenter, randomized, parallel-group, cross-over study. Female patients with diagnosis breast cancer aged more than 18 years were included.We randomized the patients into one of two study arms. In study arm A the patients are first asked to use the electronic, web-based tool to document the patient questionnaire (EORTC QLQ C-30 and FACT-B). Afterwards the patients were asked to fill and evaluate the paper-based questionnaires accordingly, followed by evaluation of usability, acceptance and capability. In study arm B the course varies by meaning that paper-based evaluation will be followed by the assessment of electronic data capture.
Results
N=110 patients with breast cancer in adjuvant or neoadjuvant situation completing the study during an outpatient visit at the University Hospitals in Tuebingen and the National Cancer Centre Heidelberg (average age: 52.4). In most patients, there were no differences in terms of acceptance between pPRO and ePRO. Only in some older patients with a lower quality of life hurdles for ePRO could be identified, because of lower acceptance rates. We could not find significant differences in response behavior between pPRO and ePRO.
Discussion
Because no differences in response behavior could be identified, the tool can be define as reliable possibility to measure patient reported outcomes. E-PRO surveys appear to be suitable for use in breast cancer patients. However, there is a need of support in older and more ill patients, to participate form the technical capabilities of ePRO.
Citation Format: Wallwiener M, Simoes E, Hartkopf AD, Taran F-A, Keilmann L, Sickenberger N, Stevanovic S, Belleville E, Ladra C, Schneeweiss A, Wallwiener D, Brucker SY, Graf J. Reliability and acceptance of e-based survey instruments for measuring patient reported outcomes (PRO) in breast cancer patients: First results of the ePROCOM study [abstract]. In: Proceedings of the 2016 San Antonio Breast Cancer Symposium; 2016 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2017;77(4 Suppl):Abstract nr P3-11-05.