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

NCT05644821 | Unknown DMC

• 1 other identifier: 2022-2148
• Study Type: interventional
• Target: 260
• Locations: 1 country
• Sites: 5

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.

Conditions

Prostate Cancer

Outcome Measures

Primary Outcomes (1)

• urinary incontinence

  The Expanded Prostate Cancer Index Short Form (EPIC-26) is a questionnaire that assesses symptoms and functions of people with prostate cancer in 5 domains. A total of 100 points can be achieved for each domain, with a higher score indicating better function. The urinary incontinence domain consists of four items. To calculate the primary endpoint, the difference between the scores on the urinary incontinence scale of the EPIC-26 is taken at 52 and 6 weeks. Changes regarding urinary incontinence (Minimally Important Difference (MID) \>= 9) at 52 weeks postoperatively compared with 6 weeks postoperatively are considered.

  52 weeks

Secondary Outcomes (11)

• EPIC-26: changes in sexual function

  52 weeks

• EPIC-26: changes in irritative/obstructive symptoms

  52 weeks

• EPIC-26: changes in gastrointestinal symptoms

  36 months

• EPIC-26: changes in vitality/hormonal function

  52 weeks

• EQ-5D-5L: changes in health-related quality of life (HRQoL)

  52 weeks

Study Arms (3)

Intervention group

EXPERIMENTAL

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.

Other: complex intervention

Control group

NO INTERVENTION

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.

Comparison group

OTHER

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.

Other: current clinical practice

Interventions

complex intervention 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.

Intervention group

current clinical practice OTHER

current clinical practice

Comparison group

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Heinrich-Heine University, Duesseldorf: lead
• Marienhospital Herne: collaborator
• University Hospital, Essen: collaborator
• University Hospital, Bonn: collaborator
• Klinikum Dortmund gGbmH: collaborator
• University Hospital Muenster: collaborator
• University Hospital of Cologne: collaborator
• University of Cologne: collaborator
• Techniker Krankenkasse: collaborator
• Deutsche Krebsgesellschaft e.V.: collaborator

Study Sites (5)

University Clinic Bonn, Urology

Bonn, North Rhine Westpahlia, 53127, Germany

RECRUITING

Klinikum Dortmund gGmbH, Urology

Dortmund, North Rhine-Westphalia, 44145, Germany

RECRUITING

University Clinic Düsseldorf, Urology

Düsseldorf, North Rhine-Westphalia, 40223, Germany

RECRUITING

University Clinik Bochum, Marienhospital Herne, Urology

Herne, North Rhine-Westphalia, 44625, Germany

RECRUITING

University Clinic Münster, Urology

Münster, North Rhine-Westphalia, 48149, Germany

RECRUITING

Related Publications (1)

• 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.

  PMID: 39533412 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Peter Albers, MD

  University Clinic Düsseldorf, Urology

  PRINCIPAL INVESTIGATOR

• André Karger, MD

  University Clinic Düsseldorf, psychosomatic medicine

  STUDY DIRECTOR

Central Study Contacts

Dominik Fugmann, MD

CONTACT

+49 (0)211-81 18 33 8; dominik.fugmann@med.uni-duesseldorf.de

Johanna Droop, PhD

CONTACT

+49 (0)211-81 18110; johanna.droop@med.uni-duesseldorf.de

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Intention-to-treat principle, comparison (regarding superiority) of primary endpoint using mixed linear model for repeated measures: dependent variable: primary endpoint, influencing factors: Indicator for intervention/control group, time, group\*time, center, tumor stage, and age group; downstream sequential-rejection testing of equality of expected values in the individual strata via appropriate contrasts; control of multiple error for at least one false rejection (final test principle); supplementary: mixed linear models with additional independent variables; sensitivity analyses on the influence of missing values (multiple imputation); subgroup analyses according to center, stage, and age group

Study Record Dates

• First Submitted: November 18, 2022
• First Posted: December 9, 2022
• Study Start: August 1, 2023
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: October 1, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5)