Brief Title
Patient-reported Outcomes in Bladder Cancer
Official Title
Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
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
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.
Study Type
Interventional
Primary Outcome
Rate of completion of treatment
Secondary Outcome
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)
Condition
Bladder Cancer
Intervention
Electronic patient-reported outcomes
Study Arms / Comparison Groups
Standard of care
Description: This arm will continue standard procedure regarding side effect registration and handling
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Device
Estimated Enrollment
230
Start Date
January 21, 2019
Completion Date
March 31, 2022
Primary Completion Date
September 30, 2021
Eligibility Criteria
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
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Gry Assam Taarnhøj, MD, ,
Location Countries
Denmark
Location Countries
Denmark
Administrative Informations
NCT ID
NCT03584659
Organization ID
iBLAD2018
Responsible Party
Principal Investigator
Study Sponsor
Rigshospitalet, Denmark
Collaborators
Herlev Hospital
Study Sponsor
Gry Assam Taarnhøj, MD, Principal Investigator, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
Verification Date
May 2021