Clinical trial · Interventional
Influence of Electronic Patient Reported Outcomes (ePROMs) in Surgical Therapy for Prostate Cancer on Postoperative Outcome
NCT05644821CI-TRIAL-00124181PRO-PcompletedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| complex intervention | Other | — | UNRESOLVED |
| current clinical practice | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Other: complex intervention
- type
- NO_INTERVENTION
- label
- Control group
- description
- 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.
- type
- OTHER
- label
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDAl-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