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

  1. Al-Monajjed, Rouvier
  2. Albers, Peter
  3. Droop, Johanna
  4. Fugmann, Dominik ORCID logo
  5. Noldus, Joachim
  6. Palisaar, Rein-Jüri
  7. Ritter, Manuel
  8. Ellinger, Jörg
  9. Krausewitz, Philipp
  10. Truß, Michael
  11. Hadaschik, Boris
  12. Grünwald, Viktor
  13. Schrader, Andres-Jan
  14. Papavassilis, Philipp
  15. Ernstmann, Nicole
  16. Schellenberger, Barbara
  17. Moritz, Anna
  18. Kowalski, Christoph
  19. Hellmich, Martin ORCID logo
  20. Heiden, Pierce ORCID logo
  21. Hagemeier, Anna
  22. Horenkamp-Sonntag, Dirk
  23. Giessing, Markus
  24. Pauler, Luis
  25. Dieng, Sebastian
  26. Peters, Maria
  27. Feick, Günter
  28. Andre, Karger ORCID logo
  29. PRO-P study group
  30. Bleiziffer, Isabelle
  31. Bußhoff, Isabelle
  32. Winterhagen, Franziska
  33. Tschirhart, Alix
  34. Knappe, Franziska
  35. Shiminazzo, Caterina
  36. Dung, Julia
  37. Oberbeck, Chantal
  38. Seidemann, Sonja
  39. Würdig, Sabine
  40. Darr, Christopher
  41. Kesch, Claudia
  42. Brinkforth, Tanja
  43. Shakib, Fereshteh Sadeghi
  44. Echterhoff, Maria
  45. Raubach, Litha
  46. Greese-Turki, Marleen
  47. Neumann, Julia
  48. Frehse, Julia Cornelia
  49. Jakob Michaelis, Nils
  50. Schwarzer, Carsten
  51. Busse, Luis Linda
  52. Rausch, Patricia
  53. Silberg, Matteo
  54. Fritz, Katja
  55. Giersbach, Giulia
  56. Mohr, Meike
  57. Wiedelmann, Stefan
  58. Voitz, Kerstin
  59. Bothe, Christiane
  60. Queißert, Fabian
  61. Flaswinkel, Helga
  62. Hermes-Moll, Kerstin

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1000 Titel
  • 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
1000 Autor/in
  1. Al-Monajjed, Rouvier |
  2. Albers, Peter |
  3. Droop, Johanna |
  4. Fugmann, Dominik |
  5. Noldus, Joachim |
  6. Palisaar, Rein-Jüri |
  7. Ritter, Manuel |
  8. Ellinger, Jörg |
  9. Krausewitz, Philipp |
  10. Truß, Michael |
  11. Hadaschik, Boris |
  12. Grünwald, Viktor |
  13. Schrader, Andres-Jan |
  14. Papavassilis, Philipp |
  15. Ernstmann, Nicole |
  16. Schellenberger, Barbara |
  17. Moritz, Anna |
  18. Kowalski, Christoph |
  19. Hellmich, Martin |
  20. Heiden, Pierce |
  21. Hagemeier, Anna |
  22. Horenkamp-Sonntag, Dirk |
  23. Giessing, Markus |
  24. Pauler, Luis |
  25. Dieng, Sebastian |
  26. Peters, Maria |
  27. Feick, Günter |
  28. Andre, Karger |
  29. PRO-P study group |
  30. Bleiziffer, Isabelle |
  31. Bußhoff, Isabelle |
  32. Winterhagen, Franziska |
  33. Tschirhart, Alix |
  34. Knappe, Franziska |
  35. Shiminazzo, Caterina |
  36. Dung, Julia |
  37. Oberbeck, Chantal |
  38. Seidemann, Sonja |
  39. Würdig, Sabine |
  40. Darr, Christopher |
  41. Kesch, Claudia |
  42. Brinkforth, Tanja |
  43. Shakib, Fereshteh Sadeghi |
  44. Echterhoff, Maria |
  45. Raubach, Litha |
  46. Greese-Turki, Marleen |
  47. Neumann, Julia |
  48. Frehse, Julia Cornelia |
  49. Jakob Michaelis, Nils |
  50. Schwarzer, Carsten |
  51. Busse, Luis Linda |
  52. Rausch, Patricia |
  53. Silberg, Matteo |
  54. Fritz, Katja |
  55. Giersbach, Giulia |
  56. Mohr, Meike |
  57. Wiedelmann, Stefan |
  58. Voitz, Kerstin |
  59. Bothe, Christiane |
  60. Queißert, Fabian |
  61. Flaswinkel, Helga |
  62. Hermes-Moll, Kerstin |
1000 Verlag BioMed Central
1000 Erscheinungsjahr 2024
1000 Publikationstyp
  1. Artikel |
1000 Online veröffentlicht
  • 2024-11-12
1000 Erschienen in
1000 Quellenangabe
  • 25(1):754
1000 Copyrightjahr
  • 2024
1000 Lizenz
1000 Verlagsversion
  • https://doi.org/10.1186/s13063-024-08579-8 |
  • https://www.ncbi.nlm.nih.gov/pmc/articles/PMC11556073/ |
1000 Publikationsstatus
1000 Begutachtungsstatus
1000 Sprache der Publikation
1000 Abstract/Summary
  • <jats:title>Abstract</jats:title><jats:sec> <jats:title>Background</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Methods</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Discussion</jats:title> <jats:p>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.</jats:p> </jats:sec><jats:sec> <jats:title>Trial registration</jats:title> <jats:p>ClinicalTrials.gov NCT05644821. Registered on 09 December 2022.</jats:p> </jats:sec>
1000 Sacherschließung
lokal Prostatectomy/adverse effects [MeSH]
lokal EPIC-26
lokal Patient-reported outcomes
lokal Study Protocol
lokal Humans [MeSH]
lokal Treatment Outcome [MeSH]
lokal Continence
lokal Multicenter Studies as Topic [MeSH]
lokal Time Factors [MeSH]
lokal Patient Reported Outcome Measures [MeSH]
lokal Radical prostatectomy
lokal Urinary Incontinence/etiology [MeSH]
lokal Randomized Controlled Trials as Topic [MeSH]
lokal Quality of life
lokal Male [MeSH]
lokal Quality of Life [MeSH]
lokal Germany [MeSH]
lokal Health apps
lokal Prostatic Neoplasms/surgery [MeSH]
lokal Prostatectomy/methods [MeSH]
lokal PROM
lokal Prostate cancer
1000 Fächerklassifikation (DDC)
1000 Liste der Beteiligten
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  • DeepGreen-ID: cc457313ca554e848086d58f86f6d5c9 ; metadata provieded by: DeepGreen (https://www.oa-deepgreen.de/api/v1/), LIVIVO search scope life sciences (http://z3950.zbmed.de:6210/livivo), Crossref Unified Resource API (https://api.crossref.org/swagger-ui/index.html), to.science.api (https://frl.publisso.de/), ZDB JSON-API (beta) (https://zeitschriftendatenbank.de/api/), lobid - Dateninfrastruktur für Bibliotheken (https://lobid.org/resources/search) ; at least one of the mandatory fields 'given-names' and 'family-name' is missing for the ORCID profile of 'Hagemeier, Anna' (https://orcid.org/0000-0002-8795-7352)
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