Patient-reported Outcomes in Bladder Cancer

Bladder Cancer Clinical Trial

— iBLAD  

Official title:

Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03584659
• Other study ID #: iBLAD2018
• Status: Completed
• Phase: N/A
• Start date: January 21, 2019
• Est. completion date: March 31, 2022

Study information

• Verified date: October 2022
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: March 31, 2022
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms
• Urothelial Carcinoma

Intervention

Device:
• Electronic patient-reported outcomes
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.

Locations

Country	Name	City	State
Denmark	Aalborg University Hospital	Aalborg
Denmark	Department of Oncology, Rigshospitalet	Copenhagen
Denmark	Department of Oncology	Herlev
Denmark	Odense University Hospital	Odense

Sponsors (5)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Aalborg University Hospital, Danish Cancer Society, Herlev Hospital, Odense University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate of completion of treatment	Registration of whether patients complete the planned treatment and if not if the cessation was preventable.	Within the first 6 months of treatment
Primary	Hospital admission	Registration of whether patients by closer contact to clinic between visits can decrease the rate of hospital admissions for preventable causes during treatment.	Within the first 6 months of treatment
Secondary	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)	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).	Within the first 6 months of treatment
Secondary	Overall survival measured from time of study initiation to death	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.	Analysis will be made up to 2 years after study completion
Secondary	Dose-reductions	Registration of differences in number of dose reductions of chemotherapy between the two arm in the study.	Within the first 6 months of treatment