Trials (Nov 2024)

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,
  • Boris Hadaschik,
  • Viktor Grünwald,
  • Andres-Jan Schrader,
  • Philipp Papavassilis,
  • Nicole Ernstmann,
  • Barbara Schellenberger,
  • Anna Moritz,
  • Christoph Kowalski,
  • Martin Hellmich,
  • Pierce Heiden,
  • Anna Hagemeier,
  • Dirk Horenkamp-Sonntag,
  • Markus Giessing,
  • Luis Pauler,
  • Sebastian Dieng,
  • Maria Peters,
  • Günter Feick,
  • André Karger,
  • PRO-P study group

DOI
https://doi.org/10.1186/s13063-024-08579-8
Journal volume & issue
Vol. 25, no. 1
pp. 1 – 17

Abstract

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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.

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