Patient-reported Outcomes in Bladder Cancer (iBLAD)
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|ClinicalTrials.gov Identifier: NCT03584659|
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 11, 2019
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
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer Urothelial Carcinoma||Device: Electronic patient-reported outcomes||Not Applicable|
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 (Clinical Trial)|
|Estimated Enrollment :||230 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study|
|Actual Study Start Date :||January 21, 2019|
|Estimated Primary Completion Date :||March 31, 2020|
|Estimated Study Completion Date :||March 31, 2022|
No Intervention: Standard of care
This arm will continue standard procedure regarding side effect registration and handling
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.
Device: Electronic patient-reported outcomes
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
- Rate of completion of treatment [ Time Frame: Within the first 6 months of treatment ]Registration of whether patients complete the planned treatment and if not if the cessation was preventable.
- Hospital admission [ Time Frame: Within the first 6 months of treatment ]Registration of whether patients by closer contact to clinic between visits can decrease the rate of hospital admissions for preventable causes during treatment.
- 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 ]
Registration of differences in quality of life between the two arms in the study. EORTC QLQ-C30(scale range 0-100, a higher score indicating better quality of life) and QLQ-BLM30(scale range 0-100, a higher score indicating increase in symptom burden) will be used for as quality of life measurement. The scores will be presented graphically in separate figures. The EORTC QLQ-BLM30 cannot be applied without the QLQ-C30, hence the aggregation of measures in the present outcome measure category.
Differences between the two arms will be tested using t-test and analysis of covariance (ANCOVA).
- Overall survival measured from time of study initiation to death [ Time Frame: Analysis will be made up to 2 years after study completion ]Differences in median overall survival and analysis of survival differences between the intervention-arm and the standard of care arm. The analysis will be carried out with log-rank analysis and Kaplan-Meier curves. The analysis will be carried out separately for chemotherapy and immunotherapy recipients.
- Dose-reductions [ Time Frame: Within the first 6 months of treatment ]Registration of differences in number of dose reductions of chemotherapy between the two arm in the study.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584659
|Contact: Gry Assam Taarnhøj, MD||+45 firstname.lastname@example.org|
|Contact: Helle Pappot, MD, DMSc||+45 email@example.com|
|Aalborg University Hospital||Recruiting|
|Aalborg, Denmark, 9000|
|Contact: Andreas Carus, MD, PhD|
|Department of Oncology, Rigshospitalet||Recruiting|
|Copenhagen, Denmark, 2100|
|Contact: Gry Assam Taarnhøj, MD +45 51943003 firstname.lastname@example.org|
|Contact: Helle Pappot, MD, DMSc email@example.com|
|Department of Oncology||Recruiting|
|Herlev, Denmark, 2730|
|Contact: Henriette Lindberg, MD, PhD firstname.lastname@example.org|
|Contact: Line Hammer Dohn, MD, PhD|
|Odense University Hospital||Recruiting|
|Odense, Denmark, 5000|
|Contact: Rikke Hedegaard Dahlrot, MD, PhD|
|Principal Investigator:||Gry Assam Taarnhøj, MD||Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark|