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

Summary

The study investigates the influence of structured follow-up using ePROMS in the 1st year after prostatectomy on the postoperative course. It will be examined whether this intervention leads to early detection of postoperative symptoms and whether the subsequent initiation of further measures lead to an improvement of incontinence, symptom burden, quality of life and patient competence.

Conditions

• Prostate Cancer

Interventions

OTHER

complex intervention

The intervention has several elements: 1. Regular symptom monitoring via ePROMs 2. Alarm when defined thresholds of EPIC-26 or PHQ-4 are reached or exceeded, 3.) In case of alarm, standardized telephone contact by a study nurse at the treating center with the offer to coordinate a urological consultation at the center, 4.) if requested by the patient: a urological consultation at the treating prostate cancer center by urologists trained in the PRO-P study, 4\) content of the consultation: if necessary, the guideline-compliant initiation of further diagnostics and therapy including in this context necessary follow-up contacts and 5) postal communication of the ePROM results in case of an alarm as well as postal dispatch of a report of the findings in case of a urological consultation at the treating prostate cancer center to the practicing, treating urologist.

OTHER

current clinical practice

current clinical practice

Sponsors & Collaborators

• Marienhospital Herne

  collaborator OTHER

• University Hospital, Essen

  collaborator OTHER

• University Hospital, Bonn

  collaborator OTHER

• Klinikum Dortmund gGbmH

  collaborator UNKNOWN

• University Hospital Muenster

  collaborator OTHER

• University Hospital of Cologne

  collaborator OTHER

• University of Cologne

  collaborator OTHER

• Techniker Krankenkasse

  collaborator OTHER

• Deutsche Krebsgesellschaft e.V.

  collaborator OTHER

• Heinrich-Heine University, Duesseldorf

  lead OTHER

Principal Investigators

• Peter Albers, MD · University Clinic Düsseldorf, Urology

• André Karger, MD · University Clinic Düsseldorf, psychosomatic medicine

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

MALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2023-08-01

Primary Completion

2025-03-31

Completion

2025-03-31

Countries

• Germany

Study Locations