Bladder CanceriBLADNCT03584659
Patient-reported Outcomes in Bladder Cancer
A study testing Electronic patient-reported outcomes in people with Bladder Cancer and Urothelial Carcinoma, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bladder Cancer, Urothelial Carcinoma
- What is being tested?
- Electronic patient-reported outcomes
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 230 participants
- Where
- 4 sitesDenmark
- Study dates
- 21 Jan 2019to 31 Mar 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Urothelial carcinoma
- Initiating chemo- or immunotherapy
- No serious cognitive deficits
- Read and understand Danish
- Assigned electronic communication with health services with "E-boks"
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Denmark4 sites
Aalborg University Hospital
Aalborg, 9000
Department of Oncology, Rigshospitalet
Copenhagen, 2100
Department of Oncology
Herlev, 2730
Odense University Hospital
Odense, 5000
About this study
Official title: 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
Read the 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.
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Being tested
- Electronic patient-reported outcomes
- Keywords
- Patient-reported outcomes, Electronic reporting of symptoms, Immunotherapy, Chemotherapy
- Medical subject headings
- Urinary Bladder Neoplasms, Carcinoma, Transitional Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic patient-reported outcomesDevice
Also called Alert-algorithm, Real-time guidance of patients when symptom reporting, Alerts to clinical staff
Weekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles.
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | No intervention | This arm will continue standard procedure regarding side effect registration and handling |
| PRO | Experimental | 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. Receives: Device: Electronic patient-reported outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of completion of treatment
Registration of whether patients complete the planned treatment and if not if the cessation was preventable.
Measured: Within the first 6 months of treatment
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.
Measured: Within the first 6 months of treatment
Secondary outcomes (3)
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).
Measured: Within the first 6 months of treatment
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.
Measured: Analysis will be made up to 2 years after study completion
Dose-reductions
Registration of differences in number of dose reductions of chemotherapy between the two arm in the study.
Measured: Within the first 6 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2018
- Study start21 Jan 2019
- Primary completion30 Sep 2021
- Study completion31 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bladder CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- Herlev Hospital, Danish Cancer Society, Aalborg University Hospital, Odense University Hospital
- Responsible party
- Principal investigator, Helle Pappot, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Gry Assam Taarnhøj, MD, Principal investigator, Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03584659
- Sponsor's protocol ID
- iBLAD2018
- Acronym
- iBLAD
- Status last verified
- Oct 2022
- First submitted
- 21 Jun 2018
- Last updated
- 25 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37812306
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
- ClinicalTrials.gov ID
- NCT03584659
- Acronym / sponsor ID
- iBLAD / iBLAD2018
- Conditions
- Bladder Cancer, Urothelial Carcinoma
- Keywords
- Patient-reported outcomes, Electronic reporting of symptoms, Immunotherapy, Chemotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- Herlev Hospital, Danish Cancer Society, Aalborg University Hospital, Odense University Hospital
- Study start
- 21 Jan 2019 (actual)
- Primary completion
- 30 Sep 2021 (actual)
- Study completion
- 31 Mar 2022 (actual)
- First posted
- 12 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | No intervention | –This arm will continue standard procedure regarding side effect registration and handling |
| PRO | Experimental | Device: Electronic patient-reported outcomesThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Urothelial carcinoma
- Initiating chemo- or immunotherapy
- No serious cognitive deficits
- Read and understand Danish
- Assigned electronic communication with health services with "E-boks"
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Electronic patient-reported outcomesAlso: Alert-algorithm, Real-time guidance of patients when symptom reporting, Alerts to clinical staffWeekly reporting of patient-reported outcomes for closer contact between patient and clinic between treatment cycles. | Device | PRO |
Primary outcome
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.
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.
3 secondary outcomes
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
Overall survival measured from time of study initiation to death
Time frame: Analysis will be made up to 2 years after study completion
Dose-reductions
Time frame: Within the first 6 months of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2022.
- Derived from this study: PubMed 37812306Taarnhoj 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gry Assam Taarnhøj, MD principal investigator
Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Electronic patient-reported outcomes in people with Bladder Cancer and Urothelial Carcinoma, run by Copenhagen University Hospital, Rigshospitalet at 4 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of completion of treatment (time frame: Within the first 6 months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03584659, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2022.