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000294466 0247_ $$2ISSN$$a1468-6694
000294466 0247_ $$2ISSN$$a1745-6215
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000294466 1001_ $$aAl-Monajjed, Rouvier$$b0
000294466 245__ $$aPRO-P: evaluating the effect of electronic patient-reported outcome measures monitoring compared with standard care in prostate cancer patients undergoing surgery-study protocol for a randomized controlled trial.
000294466 260__ $$aLondon$$bBioMed Central$$c2024
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000294466 520__ $$aWith 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.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.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.ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.
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000294466 650_7 $$2Other$$aContinence
000294466 650_7 $$2Other$$aEPIC-26
000294466 650_7 $$2Other$$aHealth apps
000294466 650_7 $$2Other$$aPROM
000294466 650_7 $$2Other$$aPatient-reported outcomes
000294466 650_7 $$2Other$$aProstate cancer
000294466 650_7 $$2Other$$aQuality of life
000294466 650_7 $$2Other$$aRadical prostatectomy
000294466 650_2 $$2MeSH$$aHumans
000294466 650_2 $$2MeSH$$aMale
000294466 650_2 $$2MeSH$$aPatient Reported Outcome Measures
000294466 650_2 $$2MeSH$$aProstatic Neoplasms: surgery
000294466 650_2 $$2MeSH$$aProstatectomy: adverse effects
000294466 650_2 $$2MeSH$$aProstatectomy: methods
000294466 650_2 $$2MeSH$$aQuality of Life
000294466 650_2 $$2MeSH$$aUrinary Incontinence: etiology
000294466 650_2 $$2MeSH$$aRandomized Controlled Trials as Topic
000294466 650_2 $$2MeSH$$aGermany
000294466 650_2 $$2MeSH$$aMulticenter Studies as Topic
000294466 650_2 $$2MeSH$$aTreatment Outcome
000294466 650_2 $$2MeSH$$aTime Factors
000294466 7001_ $$0P:(DE-He78)f84639cbc39bc20ecda8d00e6de97578$$aAlbers, Peter$$b1$$udkfz
000294466 7001_ $$aDroop, Johanna$$b2
000294466 7001_ $$00000-0003-2282-3932$$aFugmann, Dominik$$b3
000294466 7001_ $$aNoldus, Joachim$$b4
000294466 7001_ $$aPalisaar, Rein-Jüri$$b5
000294466 7001_ $$aRitter, Manuel$$b6
000294466 7001_ $$aEllinger, Jörg$$b7
000294466 7001_ $$aKrausewitz, Philipp$$b8
000294466 7001_ $$aTruß, Michael$$b9
000294466 7001_ $$aHadaschik, Boris$$b10
000294466 7001_ $$aGrünwald, Viktor$$b11
000294466 7001_ $$aSchrader, Andres-Jan$$b12
000294466 7001_ $$aPapavassilis, Philipp$$b13
000294466 7001_ $$aErnstmann, Nicole$$b14
000294466 7001_ $$aSchellenberger, Barbara$$b15
000294466 7001_ $$aMoritz, Anna$$b16
000294466 7001_ $$aKowalski, Christoph$$b17
000294466 7001_ $$00000-0001-5174-928X$$aHellmich, Martin$$b18
000294466 7001_ $$00000-0002-1318-7236$$aHeiden, Pierce$$b19
000294466 7001_ $$00000-0002-8795-7352$$aHagemeier, Anna$$b20
000294466 7001_ $$aHorenkamp-Sonntag, Dirk$$b21
000294466 7001_ $$aGiessing, Markus$$b22
000294466 7001_ $$aPauler, Luis$$b23
000294466 7001_ $$aDieng, Sebastian$$b24
000294466 7001_ $$aPeters, Maria$$b25
000294466 7001_ $$aFeick, Günter$$b26
000294466 7001_ $$00000-0002-4819-0144$$aKarger, André$$b27
000294466 7001_ $$agroup, PRO-P study$$b28$$eCollaboration Author
000294466 7001_ $$aBleiziffer, Isabelle$$b29$$eContributor
000294466 7001_ $$aBußhoff, Isabelle$$b30$$eContributor
000294466 7001_ $$aWinterhagen, Franziska$$b31$$eContributor
000294466 7001_ $$aTschirhart, Alix$$b32$$eContributor
000294466 7001_ $$aKnappe, Franziska$$b33$$eContributor
000294466 7001_ $$aShiminazzo, Caterina$$b34$$eContributor
000294466 7001_ $$aDung, Julia$$b35$$eContributor
000294466 7001_ $$aOberbeck, Chantal$$b36$$eContributor
000294466 7001_ $$aSeidemann, Sonja$$b37$$eContributor
000294466 7001_ $$aWürdig, Sabine$$b38$$eContributor
000294466 7001_ $$aStudienzentrale$$b39$$eContributor
000294466 7001_ $$aDarr, Christopher$$b40$$eContributor
000294466 7001_ $$aKesch, Claudia$$b41$$eContributor
000294466 7001_ $$aBrinkforth, Tanja$$b42$$eContributor
000294466 7001_ $$aShakib, Fereshteh Sadeghi$$b43$$eContributor
000294466 7001_ $$aEchterhoff, Maria$$b44$$eContributor
000294466 7001_ $$aRaubach, Litha$$b45$$eContributor
000294466 7001_ $$aGreese-Turki, Marleen$$b46$$eContributor
000294466 7001_ $$aNeumann, Julia$$b47$$eContributor
000294466 7001_ $$aFrehse, Julia Cornelia$$b48$$eContributor
000294466 7001_ $$aJakob Michaelis, Nils$$b49$$eContributor
000294466 7001_ $$aSchwarzer, Carsten$$b50$$eContributor
000294466 7001_ $$aBusse, Luis Linda$$b51$$eContributor
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