NCT03584659

Patient-reported Outcomes in Bladder Cancer

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 230 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

Bladder cancer is in Europe the 4th most incident cancer among men and the 7th most frequent cause of cancer death. Many patients will receive chemo- or immunotherapy in either the neoadjuvant setting or for recurrent or metastatic disease. The registration and handling of side effect is crucial in bladder cancer treatment, since the missing identification and insufficient treatment of such can lead to incomplete treatment and thereby decreased effect. It is therefore of utmost importance to develop new tools which can increase identification of the side effects and improve treatment to secure the best life expectancies for these patients. This study will in a randomized trial using PRO-CTCAE™ questions, EORTC QLQ-C30 + QLQ-BLM30 in one arm versus standard procedure regarding side effect registration and handling in the other arm, test the effect of electronic reporting of side-effects and quality of life with a specifically developed alert-algorithm. Both study arms will include chemotherapy and immunotherapy patients as standard therapy.

Conditions

• Bladder Cancer
• Urothelial Carcinoma

Interventions

Type	Name	Description
DEVICE	Electronic patient-reported outcomes	Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.

Timeline

• Start date: 2019-01-21
• Primary completion: 2021-09-30
• Completion: 2022-03-31
• First posted: 2018-07-12
• Last updated: 2022-10-25

Locations

4 sites across 1 country: Denmark