Clinical trial NCT03584659: Patient-reported Outcomes in Bladder Cancer
Official title: Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Urothelial Carcinoma
Keywords: Patient-reported outcomes
Electronic reporting of symptoms
Immunotherapy
Chemotherapy
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Herlev Hospital
name: Danish Cancer Society
name: Aalborg University Hospital
name: Odense University Hospital
First posted: 2018-07-12
Enrollment: 230
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Rate of completion of treatment
timeFrame: Within the first 6 months of treatment
measure: Hospital admission
timeFrame: Within the first 6 months of treatment
Secondary outcomes:
measure: 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)
timeFrame: Within the first 6 months of treatment
measure: Overall survival measured from time of study initiation to death
timeFrame: Analysis will be made up to 2 years after study completion
measure: Dose-reductions
timeFrame: Within the first 6 months of treatment
Other outcomes:
Locations:
city: Aalborg
country: Denmark
facility: Aalborg University Hospital
city: Copenhagen
country: Denmark
facility: Department of Oncology, Rigshospitalet
city: Herlev
country: Denmark
facility: Department of Oncology
city: Odense
country: Denmark
facility: Odense University Hospital
Study officials:
affiliation: Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
name: Gry Assam Taarnhøj, MD
role: PRINCIPAL_INVESTIGATOR
References: