Patient-reported Outcomes in Bladder Cancer (iBLAD)

October 24, 2022 updated by: Helle Pappot, Rigshospitalet, Denmark

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

230

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aalborg, Denmark, 9000
        • Aalborg University Hospital
      • Copenhagen, Denmark, 2100
        • Department of Oncology, Rigshospitalet
      • Herlev, Denmark, 2730
        • Department of Oncology
      • Odense, Denmark, 5000
        • Odense University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Standard of care
This arm will continue standard procedure regarding side effect registration and handling
Experimental: 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.
Device: Electronic patient-reported outcomes
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
Other Names:
  • Real-time guidance of patients when symptom reporting
  • Alert-algorithm
  • Alerts to clinical staff

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first 6 months of treatment
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.
Within the first 6 months of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Time Frame: Within the first 6 months of treatment

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
Overall survival measured from time of study initiation to death
Time Frame: Analysis will be made up to 2 years after study completion
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
Dose-reductions
Time Frame: Within the first 6 months of treatment
Registration of differences in number of dose reductions of chemotherapy between the two arm in the study.
Within the first 6 months of treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

Odense University Hospital
Danish Cancer Society
Herlev Hospital
Aalborg University Hospital

Investigators

  • Principal Investigator: Gry Assam Taarnhøj, MD, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 21, 2019

Primary Completion (Actual)

September 30, 2021

Study Completion (Actual)

March 31, 2022

Study Registration Dates

First Submitted

June 21, 2018

First Submitted That Met QC Criteria

July 11, 2018

First Posted (Actual)

July 12, 2018

Study Record Updates

Last Update Posted (Actual)

October 25, 2022

Last Update Submitted That Met QC Criteria

October 24, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • iBLAD2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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