Ignite Creation Date:
2025-12-24 @ 3:02 PM
Ignite Modification Date:
2025-12-25 @ 6:21 PM
Study NCT ID:
NCT03584659
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2018-06-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient-reported Outcomes in Bladder Cancer
Sponsor:
Rigshospitalet, Denmark
Organization:
Study Overview
Official Title:
Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
Status:
COMPLETED
Status Verified Date:
2022-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
iBLAD
Brief 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
* 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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: