Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study

Condition: Bladder Cancer, Urothelial Carcinoma

Intervention:

• Device: Electronic patient-reported outcomes

Purpose: 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

Study Type: Interventional

Clinical Trials Identifier NCT 8-digits: NCT03584659

Sponsor: Rigshospitalet, Denmark

Primary Outcome Measures:

• Measure: Rate of completion of treatment
• Time Frame: Within the first 6 months of treatment
• Safety Issue:
• Measure: Hospital admission
• Time Frame: Within the first 6 months of treatment
• Safety Issue:

Secondary Outcome Measures:

• Measure: Quality of life questionnaires EORTC QLQ-C30 (general quality of life questionnaire) and EORTC QLQ-BLM30(quality of life questionnaire specifically for muscle-invasive bladder cancer patients)
• Time Frame: Within the first 6 months of treatment
• Safety Issue:
• Measure: Overall survival measured from time of study initiation to death
• Time Frame: Analysis will be made up to 2 years after study completion
• Safety Issue:
• Measure: Dose-reductions
• Time Frame: Within the first 6 months of treatment
• Safety Issue:

Estimated Enrollment: 230

Study Start Date: January 21, 2019

Eligibility:

• Age: minimum 18 Years maximum N/A
• Gender: All

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

Contact:

• Gry Assam Taarnhøj, MD
• gry.assam.taarnhoej@regionh.dk
• +45 35450737

Locations:

• Aalborg University Hospital
• Aalborg 9000 Denmark

• Department of Oncology, Rigshospitalet
• Copenhagen 2100 Denmark

• Department of Oncology
• Herlev 2730 Denmark

• Odense University Hospital
• Odense 5000 Denmark

View trial on ClinicalTrials.gov