Using electronic patient-reported outcomes to improve recovery after prostate surgery
Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome
This study is testing if using an app for patients to report their symptoms after prostate surgery can help them recover better and feel healthier compared to regular follow-up care.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | Male |
| Sponsor | Heinrich-Heine University, Duesseldorf Academic / other |
| Locations | 5 sites (Bonn, North Rhine Westpahlia and 4 other locations) |
| Trial ID | NCT05644821 on ClinicalTrials.gov |
What this trial studies
This study investigates how structured follow-up using electronic patient-reported outcomes (ePROMs) affects postoperative outcomes in patients undergoing prostatectomy for prostate cancer. It is a multicenter, prospective, randomized control trial where patients will report their symptoms through an app or web tool at various intervals after surgery. The intervention group will receive immediate alerts and follow-up care based on their ePROM responses, while the control group will follow standard clinical practices without immediate intervention. The goal is to enhance early detection of postoperative symptoms and improve quality of life and symptom management.
Who should consider this trial
Good fit: Ideal candidates are adult males aged 18 and older who are scheduled for primary radical prostatectomy and can use electronic devices for reporting outcomes.
Not a fit: Patients with preoperative urinary incontinence or those in a palliative treatment situation may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better management of postoperative symptoms and improved quality of life for prostate cancer patients.
How similar studies have performed: Other studies have shown promise in using electronic patient-reported outcomes to enhance patient care, indicating that this approach may be effective.
Eligibility criteria
Show full inclusion / exclusion 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)
Where this trial is running
Bonn, North Rhine Westpahlia and 4 other locations
- University Clinic Bonn, Urology — Bonn, North Rhine Westpahlia, Germany (Recruiting)
- Klinikum Dortmund gGmbH, Urology — Dortmund, North Rhine Westphalia, Germany (Recruiting)
- University Clinic Düsseldorf, Urology — Düsseldorf, North Rhine Westphalia, Germany (Recruiting)
- University Clinik Bochum, Marienhospital Herne, Urology — Herne, North Rhine Westphalia, Germany (Recruiting)
- University Clinic Münster, Urology — Münster, North Rhine Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Peter Albers, MD — University Clinic Düsseldorf, Urology
- Study coordinator: Dominik Fugmann, MD
- Email: dominik.fugmann@med.uni-duesseldorf.de
- Phone: +49 (0)211-81 18 33 8
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.