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

NCT ID: NCT05644821

Last Updated: 2024-10-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 260 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-08-01
• Study Completion Date: 2025-03-31

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Intervention group

Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the intervention group, when the respective questionnaire thresholds 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 actions, if necessary.

Group Type: EXPERIMENTAL

complex intervention

Intervention Type: OTHER

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.

Control group

Patients who are not fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours) are randomized into the intervention or control group. In the control group, ePROMs will be collected 24 and 52 weeks after radical prostatectomy, but without triggering an alarm with subsequent measures - the control group will therefore receive treatment according to the current clinical routine.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Comparison group

In patients who are fully continent 6-weeks post-surgery (i.e., do not use pads in 24 hours), ePROMs are collected at 24 and 52 weeks, but no alarms or further actions are derived from them. Thus, treatment is provided according to routine clinical practice. Patients are not randomized.

Group Type: OTHER

current clinical practice

Intervention Type: OTHER

current clinical practice

Interventions

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.

Intervention Type: OTHER

current clinical practice

current clinical practice

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 y
• legal capacity
• sufficient knowledge of the German language
• prostate carcinoma, TNM T1-4 NX N0-1 M0-1c
• primary radical prostatectomy planned
• mobile input device or PC available
• ability to either receive emails or install a special app on cell phone and receive push messages, with guidance or assistance if necessary
• ability to complete electronic questionnaires, with guidance or assistance if necessary

Exclusion Criteria

• palliative treatment situation (life expectancy < 1 year)
• preoperative urinary incontinence (at least one pad per 24 hours)

• Minimum Eligible Age: 18 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Marienhospital Herne

OTHER

Sponsor Role: collaborator

University Hospital, Essen

OTHER

Sponsor Role: collaborator

University Hospital, Bonn

OTHER

Sponsor Role: collaborator

Klinikum Dortmund gGbmH

UNKNOWN

Sponsor Role: collaborator

University Hospital Muenster

OTHER

Sponsor Role: collaborator

University Hospital of Cologne

OTHER

Sponsor Role: collaborator

University of Cologne

OTHER

Sponsor Role: collaborator

Techniker Krankenkasse

OTHER

Sponsor Role: collaborator

Deutsche Krebsgesellschaft e.V.

OTHER

Sponsor Role: collaborator

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Peter Albers, MD

Role: PRINCIPAL_INVESTIGATOR

University Clinic Düsseldorf, Urology

André Karger, MD

Role: STUDY_DIRECTOR

University Clinic Düsseldorf, psychosomatic medicine

Locations

University Clinic Bonn, Urology

Bonn, North Rhine Westpahlia, Germany

Site Status: RECRUITING

Klinikum Dortmund gGmbH, Urology

Dortmund, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Clinic Düsseldorf, Urology

Düsseldorf, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Clinik Bochum, Marienhospital Herne, Urology

Herne, North Rhine-Westphalia, Germany

Site Status: RECRUITING

University Clinic Münster, Urology

Münster, North Rhine-Westphalia, Germany

Site Status: RECRUITING

Countries

Germany

Central Contacts

Dominik Fugmann, MD

Role: CONTACT

dominik.fugmann@med.uni-duesseldorf.de

+49 (0)211-81 18 33 8

Johanna Droop, PhD

Role: CONTACT

johanna.droop@med.uni-duesseldorf.de

+49 (0)211-81 18110

Facility Contacts

Philipp Krausewitz, MD

Role: primary

philipp.krausewitz@ukbonn.de

Michael C Truß, MD

Role: primary

Pro-P-Studie@klinikumdo.de

Rouvier Al-Monajjed, MD

Role: primary

urologie@med.uni-duesseldorf.de

+49 0211 81 18110

Johanna Droop, PhD

Role: backup

johanna.droop@med.uni-duesseldorf.de

+49 0211 81 19414

Rein-Jüri Palisaar, MD

Role: primary

Rein-Jueri.Palisaar@elisabethgruppe.de

Meike Mohr

Role: backup

meike.mohr@elisabethgruppe.de

+49 02323 499- 1579

Philipp Papavassilis, MD

Role: primary

prostata@ukmuenster.de

References

Al-Monajjed R, Albers P, Droop J, Fugmann D, Noldus J, Palisaar RJ, Ritter M, Ellinger J, Krausewitz P, Truss M, Hadaschik B, Grunwald V, Schrader AJ, Papavassilis P, Ernstmann N, Schellenberger B, Moritz A, Kowalski C, Hellmich M, Heiden P, Hagemeier A, Horenkamp-Sonntag D, Giessing M, Pauler L, Dieng S, Peters M, Feick G, Karger A; PRO-P study group. 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. Trials. 2024 Nov 12;25(1):754. doi: 10.1186/s13063-024-08579-8.

Reference Type: DERIVED

PMID: 39533412 (View on PubMed)

Other Identifiers

2022-2148

Identifier Type: -

Identifier Source: org_study_id