Easipro3 – Enhancing Satisfaction With Prostate Cancer Treatment Decision With The Mobile Health Program Prostana: A Multicenter Randomized Controlled Trial

• Published in: Value in health Vol. 20; no. 9; p. A504
• Main Authors: Vosgerau, S, Urbanski, D, Kollenbach, P, Schöne, M, Gedamke, M, Donatz, V, Bültmann, O, Amelung, V
• Format: Journal Article
• Language: English
• Published: Lawrenceville Elsevier Science Ltd 01.10.2017
• Subjects: Cancer therapies; Clinical trials; Computer programs; Cultural differences; Decision making; Diagnosis; Ethics; Evidence based research; Evidence-based medicine; Health literacy; Internet; Intervention; Medical diagnosis; Motivation; Patient satisfaction; Patient-centered care; Patients; Physicians; Primary care; Prostate; Prostate cancer; Recruitment
• ISSN: 1098-3015; 1524-4733
• DOI: 10.1016/j.jval.2017.08.598

OBJECTIVES: Cross specialty primary care of patients with prostate cancer is challenging as patients face difficult treatment decisions due to multiple equivalent treatment options, an individual mix of comorbidities, personal preferences and considerable psychological burden following a cancer diagnosis. Several decision aids exist, but these have primarily been targeted to physicians and their effects have not been studied by means of evidence based medicine. To mitigate, patients increasingly turn to internet-based research before and after consultations. To improve shared treatment decision making and patient's health literacy a comprehensive German online-program (Prostana) has been developed based on medical guidelines. The program's key element is a patient centric dialogue software which tailors information to the needs of the patient in a highly patient friendly language. The objective and primary endpoint of the EasiPR03 study is to evaluate patients' satisfaction with their treatment decision. METHODS: Prospective multicenter and cluster-randomized controlled trial with cross over-design.To avoid spillover effects, study centers are randomized into either control- or intervention group. In the intervention group patients are offered Prostana, in the control group patients are given a standardized evidence based leaflet. Patients with a first time diagnosis are included in the study. Based on the primary endpoint the sample size has been calculated to 464 patients. The evaluation will follow Intention-to-Treat principle and analyze, among other parameters, differences in satisfaction with treatment decision using the Satisfaction with Decision Scale (SWD). RESULTS: An application for an ethics vote has been submitted in April 2017. The EasiPR03 aims to start recruitment in September 2017. First interim results are expected by January 2018. CONCLUSIONS: Given the rapid advancements in digital healthcare, high quality outcomes research studies on digital interventions and patient satisfaction are lacking. The EasiPR03 study can provide insight how innovative online-based software supports patients, relatives and physicians.