Bladder Cancer Clinical Trial
— iBLAD-appOfficial title:
The iBlad App - a National, Exploratory Study on a Multimodality Smartphone App in Bladder Cancer for Better Understanding of Symptoms, Quality of Life and Need for Supportive Care
The aims of this project are: - to develop and implement a national multimodality application for patients with bladder cancer that builds upon knowledge from the iBLAD study. - to investigate how the app, containing PRO questions on symptoms and QoL, information for health care providers, and peer-to-peer advice, can provide more knowledge on symptoms, QoL, and the need for supportive care. - to examine the usability of and patient satisfaction with the app using qualitative methods.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | December 30, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 100 Years |
Eligibility | Inclusion Criteria: - Patients with bladder cancer defined as both urothelial tract-, bladder- and urethral cancer initiating first or second-line standard therapy with either chemotherapy or immunotherapy - Age = 18 years, - Performance status = 2 - Ability to read Danish - No serious cognitive impairment - Informed consent. Exclusion Criteria: - No smartphone, - Dementia, mental alteration, or psychiatric disease that can compromise informed consent from the patient and/or adherence to the protocol and the monitoring of the trial. |
Country | Name | City | State |
---|---|---|---|
Denmark | Rigshospitalet | Copenhagen | |
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Odense University Hospital | Danish Cancer Society, Rigshospitalet, Denmark |
Denmark,
Taarnhoj GA, Johansen C, Lindberg H, Basch E, Dueck A, Pappot H. Patient reported symptoms associated with quality of life during chemo- or immunotherapy for bladder cancer patients with advanced disease. Cancer Med. 2020 May;9(9):3078-3087. doi: 10.1002/cam4.2958. Epub 2020 Mar 10. — View Citation
Taarnhoj GA, Lindberg H, Dohn LH, Omland LH, Hjollund NH, Johansen C, Pappot H. Electronic reporting of patient-reported outcomes in a fragile and comorbid population during cancer therapy - a feasibility study. Health Qual Life Outcomes. 2020 Jul 11;18(1):225. doi: 10.1186/s12955-020-01480-3. — View Citation
Taarnhoj GA, Lindberg H, Johansen C, Pappot H. Patient-reported outcomes item selection for bladder cancer patients in chemo- or immunotherapy. J Patient Rep Outcomes. 2019 Aug 22;3(1):56. doi: 10.1186/s41687-019-0141-2. — View Citation
Taarnhoj GA, Lindberg H, Johansen C, Pappot H. Patient-Reported Outcomes, Health-Related Quality of Life, and Clinical Outcomes for Urothelial Cancer Patients Receiving Chemo- or Immunotherapy: A Real-Life Experience. J Clin Med. 2021 Apr 24;10(9):1852. doi: 10.3390/jcm10091852. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Development and implementation of the iBLAD-app | To develop and implement a national multimodality application (app) for patients with bladder cancer t | 2 years | |
Secondary | App contributions | To investigate how the app, containing PRO questions on symptoms and QoL, information for health care providers, and peer-to-peer advice, can provide more knowledge on symptoms, QoL, and the need for supportive care. | 2 years | |
Secondary | Usability and evaluation | To examine the usability of and patient satisfaction with the app using qualitative methods. | 2 years |
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