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Patient-reported Outcomes in Bladder Cancer (iBLAD)

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ClinicalTrials.gov Identifier: NCT03584659
Recruitment Status : Recruiting
First Posted : July 12, 2018
Last Update Posted : July 11, 2019
Sponsor:
Collaborators:
Herlev Hospital
Danish Cancer Society
Aalborg University Hospital
Odense University Hospital
Information provided by (Responsible Party):
Helle Pappot, Rigshospitalet, Denmark

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

Condition or disease Intervention/treatment Phase
Bladder Cancer Urothelial Carcinoma Device: Electronic patient-reported outcomes Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 230 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Patient-reported Outcomes in Bladder Cancer; a Multicentre Randomized Controlled Trial: The iBLAD Study
Actual Study Start Date : January 21, 2019
Estimated Primary Completion Date : March 31, 2020
Estimated Study Completion Date : March 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer

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:
  • Alert-algorithm
  • Real-time guidance of patients when symptom reporting
  • Alerts to clinical staff




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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).


  2. 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.

  3. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03584659


Contacts
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Contact: Gry Assam Taarnhøj, MD +45 35450737 gry.assam.taarnhoej@regionh.dk
Contact: Helle Pappot, MD, DMSc +45 35455013 helle.pappot@regionh.dk

Locations
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Denmark
Aalborg University Hospital Recruiting
Aalborg, Denmark, 9000
Contact: Andreas Carus, MD, PhD         
Department of Oncology, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Gry Assam Taarnhøj, MD    +45 51943003    gry.assam.taarnhoej@regionh.dk   
Contact: Helle Pappot, MD, DMSc       helle.pappot@regionh.dk   
Department of Oncology Recruiting
Herlev, Denmark, 2730
Contact: Henriette Lindberg, MD, PhD       henriette.lindberg@regionh.dk   
Contact: Line Hammer Dohn, MD, PhD         
Odense University Hospital Recruiting
Odense, Denmark, 5000
Contact: Rikke Hedegaard Dahlrot, MD, PhD         
Sponsors and Collaborators
Rigshospitalet, Denmark
Herlev Hospital
Danish Cancer Society
Aalborg University Hospital
Odense University Hospital
Investigators
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Principal Investigator: Gry Assam Taarnhøj, MD Department of Oncology, Copenhagen University Hospital, Rigshospitalet, Denmark

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Responsible Party: Helle Pappot, Clinical Oncologist, Consultant, DMSc, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT03584659     History of Changes
Other Study ID Numbers: iBLAD2018
First Posted: July 12, 2018    Key Record Dates
Last Update Posted: July 11, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Helle Pappot, Rigshospitalet, Denmark:
Patient-reported outcomes
Electronic reporting of symptoms
Immunotherapy
Chemotherapy

Additional relevant MeSH terms:
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Urinary Bladder Neoplasms
Carcinoma, Transitional Cell
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type