Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
230 participants
INTERVENTIONAL
2019-01-21
2022-03-31
Brief Summary
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* Quality of life
* Completion of treatment
* Hospital admission
* Dose reductions
* Survival
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard of care
This arm will continue standard procedure regarding side effect registration and handling
No interventions assigned to this group
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.
Electronic patient-reported outcomes
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
Interventions
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Electronic patient-reported outcomes
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Initiating chemo- or immunotherapy
* No serious cognitive deficits
* Read and understand Danish
* Assigned electronic communication with health services with "E-boks"
Exclusion Criteria
18 Years
ALL
No
Sponsors
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Herlev Hospital
OTHER
Danish Cancer Society
OTHER
Aalborg University Hospital
OTHER
Odense University Hospital
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Helle Pappot
Clinical Oncologist, Consultant, DMSc
Principal Investigators
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Gry Assam Taarnhøj, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
Locations
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Aalborg University Hospital
Aalborg, , Denmark
Department of Oncology, Rigshospitalet
Copenhagen, , Denmark
Department of Oncology
Herlev, , Denmark
Odense University Hospital
Odense, , Denmark
Countries
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References
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Taarnhoj GA, Johansen C, Carus A, Dahlrot RH, Dohn LH, Hjollund NH, Knudsen MB, Tolver A, Lindberg H, Pappot H. The iBLAD study: patient-reported outcomes in bladder cancer during oncological treatment: a multicenter national randomized controlled trial. J Patient Rep Outcomes. 2023 Oct 9;7(1):99. doi: 10.1186/s41687-023-00640-5.
Other Identifiers
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iBLAD2018
Identifier Type: -
Identifier Source: org_study_id
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