Evidence map›Paper›PMID 39533412›Full record

ArticleTrials2024

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.

Rouvier Al-Monajjed, Peter Albers, Johanna Droop, Dominik Fugmann, Joachim Noldus, Rein-Jüri Palisaar, Manuel Ritter, Jörg Ellinger, Philipp Krausewitz, Michael Truß and 19 more

Registry-linked trialAbstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Trials, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05644821 (Influence of Electronic Patient Reported Outcomes), which is not on this map. Not yet cited in PubMed.

0numbers the graph read from it
0cells of the map it votes in
0citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT05644821 nacompletednot on this map

Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome

TypeinterventionalSponsorHeinrich-Heine University, DuesseldorfRan2023 to 2026Enrolled260ConditionsProstate CancerArmscomplex intervention, current clinical practice
3 · Its place in the literature

Who cites it

0 citing papers in PubMed.

No citing paper in PubMed yet.

4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

29 authors.

Rouvier Al-MonajjedDepartment of Urology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Düsseldorf, Germany.
Peter AlbersDepartment of Urology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Düsseldorf, Germany.
Johanna DroopDepartment of Urology, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Düsseldorf, Germany.
Dominik FugmannClinical Institute for Psychosomatic Medicine and Psychotherapy, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Düsseldorf, Germany. Dominik.fugmann@med.uni-duesseldorf.de.ORCID http://orcid.org/0000-0003-2282-3932
Joachim NoldusDepartment of Urology, Marien Hospital Herne, Ruhr-University Bochum, Bochum, Germany.
Rein-Jüri PalisaarDepartment of Urology, Marien Hospital Herne, Ruhr-University Bochum, Bochum, Germany.
Manuel RitterDepartment of Adult and Pediatric Urology, University Hospital Bonn, Bonn, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Bonn, Germany.
Jörg EllingerDepartment of Adult and Pediatric Urology, University Hospital Bonn, Bonn, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Bonn, Germany.
Philipp KrausewitzDepartment of Adult and Pediatric Urology, University Hospital Bonn, Bonn, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Bonn, Germany.
Michael TrußDepartment of Urology, Klinikum Dortmund, Dortmund, Germany.
Boris HadaschikDepartment of Urology, University Hospital Essen, Essen, Germany.
Viktor GrünwaldDepartment of Urology, University Hospital Essen, Essen, Germany.
Andres-Jan SchraderDepartment of Adult and Pediatric Urology, University Hospital Münster, Münster, Germany.
Philipp PapavassilisDepartment of Adult and Pediatric Urology, University Hospital Münster, Münster, Germany.
Nicole ErnstmannInstitute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), Chair of Health Services Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Barbara SchellenbergerInstitute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), Chair of Health Services Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Anna MoritzInstitute of Medical Sociology, Health Services Research, and Rehabilitation Science (IMVR), Chair of Health Services Research, Faculty of Medicine and University Hospital Cologne, University of Cologne, Cologne, Germany.
Christoph KowalskiDepartment of Certification - Health Services Research, German Cancer Society, Berlin, Germany.
Martin HellmichInstitute of Medical Statistics and Computational Biology (IMSB), Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0001-5174-928X
Pierce HeidenInstitute of Medical Statistics and Computational Biology (IMSB), Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0002-1318-7236
Anna HagemeierInstitute of Medical Statistics and Computational Biology (IMSB), Medical Faculty and University Hospital Cologne, University of Cologne, Cologne, Germany.ORCID http://orcid.org/0000-0002-8795-7352
Dirk Horenkamp-SonntagTechniker Krankenkasse, Hamburg, Germany.
Markus GiessingDepartment of Urology, Kliniken Maria Hilf, Mönchengladbach, Germany.
Luis PaulerOnkoZert GmbH, Neu-Ulm, Germany.
Sebastian DiengOnkoZert GmbH, Neu-Ulm, Germany.
Maria PetersAOK Rheinland/Hamburg, Düsseldorf, Germany.
Günter FeickFederal Prostate Cancer Self-Help, BPS, Bonn, Germany.
André KargerClinical Institute for Psychosomatic Medicine and Psychotherapy, Medical Faculty and University Hospital Düsseldorf, Heinrich Heine University Düsseldorf, Germany and Center for Integrated Oncology Aachen, Bonn, Cologne, Düsseldorf (CIO-ABCD, Germany), Düsseldorf, Germany.ORCID http://orcid.org/0000-0002-4819-0144
PRO-P study group

Funding

Gemeinsame Bundesausschuss 01VSF21034
6 · The paper itself

Abstract

backgroundWith 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.

methodsThe 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 registrationClinicalTrials.gov NCT05644821. Registered on 09 December 2022.

Indexed as

Patient Reported Outcome MeasuresProstatectomyProstatic NeoplasmsQuality of LifeRandomized Controlled Trials as TopicUrinary IncontinenceGermanyHumansMaleMulticenter Studies as TopicTime FactorsTreatment OutcomeContinenceEPIC-26Health appsPatient-reported outcomesPROMProstate cancerQuality of lifeRadical prostatectomy

Identifiers

PMID39533412
PMCPMC11556073

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.