Clinical trial · Interventional
Patient-reported Outcomes in Bladder Cancer
Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
NCT03584659CI-TRIAL-00061682iBLADcompletedN/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)
Electronic reporting of patient-reported outcomes with alert algorithm will be tested in a randomized trial in bladder cancer patients undergoing chemo- or immunotherapy. The clinical endpoints will be: * Quality of life * Completion of treatment * Hospital admission * Dose reductions * Survival
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
| Urothelial Carcinoma | Urothelial Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electronic patient-reported outcomes | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard of care
- description
- This arm will continue standard procedure regarding side effect registration and handling
- type
- EXPERIMENTAL
- label
- PRO
- description
- This arm will be assigned to intervention by weekly electronic reporting of side effects and quality of life. A specifically developed alert-algorithm will in real-time guide both patient and alert clinical staff if symptoms are increasing or quality of life is deteriorating.
- interventionNames
- Device: Electronic patient-reported outcomes
Primary outcomes (2)
- measure
- Rate of completion of treatment
- timeFrame
- Within the first 6 months of treatment
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Urothelial carcinoma * Initiating chemo- or immunotherapy * No serious cognitive deficits * Read and understand Danish * Assigned electronic communication with health services with "E-boks" Exclusion Criteria: * None
References
Publications (1)
- DERIVEDTaarnhoj GA, Johansen C, Carus A, Dahlrot RH, Dohn LH, Hjollund NH, Knudsen MB, Tolver A, Lindberg H, Pappot H. The iBLAD study: patient-reported outcomes in bladder cancer during oncological treatment: a multicenter national randomized controlled trial. J Patient Rep Outcomes. 2023 Oct 9;7(1):99. doi: 10.1186/s41687-023-00640-5. PMID 37812306