Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Rigshospitalet, Denmark
- Enrollment
- 230
- Locations
- 4
- Primary Endpoint
- Rate of completion of treatment
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
- Not provided
Arms & Interventions
Standard of care
This arm will continue standard procedure regarding side effect registration and handling
PRO
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.
Intervention: Electronic patient-reported outcomes (Device)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)(Within the first 6 months of treatment)
- Overall survival measured from time of study initiation to death(Analysis will be made up to 2 years after study completion)
- Dose-reductions(Within the first 6 months of treatment)
Investigators
Helle Pappot
Clinical Oncologist, Consultant, DMSc
Rigshospitalet, Denmark