PRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery—study protocol for a randomized controlled trial
Authors: Al-Monajjed Rouvier , Albers Peter , Droop Johanna , Fugmann Dominik , Noldus Joachim , Palisaar Rein-Jüri , Ritter Manuel , Ellinger Jörg , Krausewitz Philipp , Truß Michael , Hadaschik Boris , Grünwald Viktor , Schrader Andres-Jan , Papavassilis Philipp , Ernstmann Nicole , Schellenberger Barbara , Moritz Anna , Kowalski Christoph , Hellmich Martin , Heiden Pierce , Hagemeier Anna , Horenkamp-Sonntag Dirk , Giessing Markus , Pauler Luis , Dieng Sebastian , Peters Maria , Feick Günter , Karger André ,   PRO-P study group, Bleiziffer Isabelle , Bußhoff Isabelle , Winterhagen Franziska , Tschirhart Alix , Knappe Franziska , Shiminazzo Caterina , Dung Julia , Oberbeck Chantal , Seidemann Sonja , Würdig Sabine , Studienzentrale  , Darr Christopher , Kesch Claudia , Brinkforth Tanja , Shakib Fereshteh Sadeghi , Echterhoff Maria , Raubach Litha , Greese-Turki Marleen , Neumann Julia , Frehse Julia Cornelia , Jakob Michaelis Nils , Schwarzer Carsten , Busse Luis Linda , Rausch Patricia , Silberg Matteo , Fritz Katja , Giersbach Giulia , Mohr Meike , Wiedelmann Stefan , Voitz Kerstin , Bothe Christiane , Queißert Fabian , Flaswinkel Helga , Hermes-Moll Kerstin 
Published: November 2024

Abstract
Background
With over 65,000 new cases per year in Germany, prostate cancer (PC) is the most common cancer in men in Germany. Localized PC is often treated by radical prostatectomy and has a very good prognosis. Postoperative quality of life (QoL) is significantly influenced by the side effects of surgery. One possible approach to improve QoL is postoperative symptom monitoring using ePROMs (electronic patient-reported outcome measures) to accurately identify any need for support.

Methods
The PRO-P (“Influence of ePROMS in surgical therapy of PC on the postoperative course”) study is a randomized controlled trial employing 1:1 randomization at 6 weeks postoperatively, involving 260 patients with incontinence (≥ 1 pad/day) at six participating centers. Recruitment is planned for 1 year with subsequent 1-year follow-up. PRO-monitoring using domains of EPIC-26, psychological burden, and QoL are assessed 6, 12, 18, 24, 36, and 52 weeks postoperatively. Exceeding predefined PRO-score cutoffs triggers an alert at the center, prompting patient contact, medical consultation, and potential interventions. The primary endpoint is urinary continence. Secondary endpoints refer to EPIC-26 domains, psychological distress, and QoL. Aspects of feasibility, effect, and implementation of the intervention will be investigated within the framework of a qualitative process evaluation.

Discussion
PRO-P investigates the effect on postoperative symptom monitoring of a structured follow-up using ePROMs in the first year after prostatectomy. It is one of the first studies in cancer surgery investigating PRO-monitoring and its putative applicability to routine care. Patient experiences with intensified monitoring of postoperative symptoms and reflective counseling will be examined in order to improve primarily urinary continence, and secondly other burdens of physical and psychological symptoms, quality-of-life, and patient competence. The potential applicability of the intervention in clinical practice is facilitated by IT adaption to the certification standards of the German Cancer Society and the integration of the ePROMs survey via a joint patient portal. Positive outcomes could readily translate this complex intervention into routine clinical care. PRO-P might improve urinary incontinence and QoL in patients with radical prostatectomy through the structured use of ePROMs.

Trial registration
ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.