NCT05644821

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 260 (estimated)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: Male
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

PRO-P is planned as a multicenter, prospective, and two-arm randomized control group study in which ePROMs will be performed in a standardized fashion once before and six times (intervention group) or three times (control group) after primary prostatectomy in patients with PCa. PROMs are collected either web-based or through a dedicated app and entered by the patient using either a mobile device or computer. Patients are invited to enter ePROMS into the app or web tool through email and app-driven push messages. Patients who are incontinent (at least one pad in 24 hours) at the 6-week postoperative survey are randomized into two groups: The intervention group and the control group. In the intervention group, when the respective questionnaire cut-off values are exceeded in the ePROM survey, an alarm is triggered at the treating prostate cancer center and contact is made by the center as well as subsequent measures, if necessary. This is done at 6 weeks postoperatively and at 12, 18, 24, 36 and 52 weeks postoperatively. In the control group, ePROMs are recorded 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group thus receives treatment in accordance with the current clinical routine. The mechanisms of action of the intervention will be investigated within the framework of a qualitative process evaluation. Characteristics on the patient level (e.g., treatment-related attitudes, comorbidity, social support), on the practitioner level (e.g., communication skills), on the organizational level, and the interactions between the levels (e.g., patient-doctor relationship) will be explored. The goal is to develop an intervention model, or to describe the effective elements of the intervention.

Conditions

• Prostate Cancer

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-01
• Primary completion: 2025-03-01
• Completion: 2025-03-01
• First posted: 2022-12-09
• Last updated: 2024-10-01

Locations

5 sites across 1 country: Germany