Patient-reported Outcomes in Bladder Cancer

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Brief Title

Patient-reported Outcomes in Bladder Cancer

Official Title

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

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.

Study Type

Interventional

Primary Outcome

Rate of completion of treatment

Secondary Outcome

 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)

Condition

Bladder Cancer

Intervention

Electronic patient-reported outcomes

Study Arms / Comparison Groups

 Standard of care
Description:  This arm will continue standard procedure regarding side effect registration and handling

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Device

Estimated Enrollment

230

Start Date

January 21, 2019

Completion Date

March 31, 2022

Primary Completion Date

September 30, 2021

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

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Gry Assam Taarnhøj, MD, ,

Location Countries

Denmark

Location Countries

Denmark

Administrative Informations

NCT ID

NCT03584659

Organization ID

iBLAD2018

Responsible Party

Principal Investigator

Study Sponsor

Rigshospitalet, Denmark

Collaborators

 Herlev Hospital

Study Sponsor

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

Verification Date

May 2021