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

  • 0Department 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.

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Summary

This summary is machine-generated.

This study explored using electronic patient-reported outcome measures (ePROMs) for prostate cancer (PC) patients after surgery. Structured monitoring with ePROMs may improve urinary continence and quality of life post-prostatectomy.

Area Of Science

  • Oncology
  • Surgical Oncology
  • Health Services Research

Background

  • Prostate cancer (PC) is the most common cancer in men in Germany, with localized disease often treated by radical prostatectomy.
  • Postoperative quality of life (QoL) is significantly impacted by surgical side effects.
  • Electronic patient-reported outcome measures (ePROMs) offer a potential method for improving QoL through postoperative symptom monitoring.

Purpose Of The Study

  • To investigate the impact of structured postoperative symptom monitoring using ePROMs on patients undergoing radical prostatectomy.
  • To assess the potential of ePROMs to improve urinary continence, psychological burden, and overall quality of life in the first year after surgery.
  • To evaluate the feasibility, effectiveness, and implementation of ePROMs in routine clinical care for prostate cancer patients.

Main Methods

  • A randomized controlled trial (PRO-P study) involving 260 patients with post-prostatectomy incontinence.
  • 1:1 randomization with follow-up assessments at 6, 12, 18, 24, 36, and 52 weeks postoperatively.
  • Monitoring of urinary continence, EPIC-26 domains, psychological burden, and QoL, with alerts triggering patient contact and interventions.

Main Results

  • The primary endpoint is to determine the effect on urinary continence.
  • Secondary endpoints include improvements in EPIC-26 domains, psychological distress, and QoL.
  • A qualitative process evaluation will examine feasibility, effect, and implementation aspects.

Conclusions

  • The PRO-P study is among the first to investigate PRO-monitoring in cancer surgery for potential routine care applicability.
  • Structured follow-up using ePROMs may enhance urinary continence and QoL in patients post-prostatectomy.
  • Successful implementation could involve IT adaptation to German Cancer Society standards and integration via a joint patient portal.

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