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CONQUER: The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life

Sponsor
Aarhus University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05195515
Collaborator
Aarhus University, Institute of Clinical Medicine (Other), National Research Center for Survivorship and Late Adverse Effects Following Pelvic Organ Cancer, Denmark (Other)
2,000
Enrollment
5
Locations
72
Anticipated Duration (Months)
400
Patients Per Site
5.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Bladder Cancer prognosis, treatment, and subsequent morbidity and mortality vary between the different stages, thus resulting in a different impact on patients' lives. There are some well known late effects of the treatments for bladder cancer, but the knowledge of their impact on patients Quality of Life is sparse. This study aims to determine the prevalence of late effects impact on Quality of Life and potential risk factors for impairment.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Anticipated Enrollment :
    2000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    The Impact of Late Effects After Treatment for Bladder Cancer on Quality of Life - What is the Cost of the Cure?
    Actual Study Start Date :
    Jan 1, 2022
    Anticipated Primary Completion Date :
    Dec 31, 2027
    Anticipated Study Completion Date :
    Dec 31, 2027

    Outcome Measures

    Primary Outcome Measures

    1. Quality of Life [5 years from baseline inclusion]

      Changes in Quality of Life measured using validated instruments

    Secondary Outcome Measures

    1. Prevalence of late effects [5 years from baseline inclusion]

      Based on Patient Reported Outcomes and medical records

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients are eligible if they are referred to a hospital in the Central Region Denmark, due to hematuria between 01/01/2022 and 01/01/2023

    • Ability to understand written and oral Danish

    Exclusion Criteria:

    • Known Alzheimers disease

    • Diagnosed other causes explaining the hematuria

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Urology, Aarhus University Hospital Aarhus N Denmark 8200
    2 Department of Urology, Regional Hospital Gødstrup Gødstrup Denmark 7400
    3 Department of Urology, Regional Hospital Horsens Horsens Denmark 8700
    4 Department of Urology, Regional Hospital Randers Randers Denmark 8900
    5 Department of Urology, Regional Hospital Viborg Viborg Denmark 8800

    Sponsors and Collaborators

    • Aarhus University Hospital
    • Aarhus University, Institute of Clinical Medicine
    • National Research Center for Survivorship and Late Adverse Effects Following Pelvic Organ Cancer, Denmark

    Investigators

    • Principal Investigator: Jørgen Bjerggaard Jensen, Professor, Department of Urology, Aarhus University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jørgen Bjerggaard Jensen, Professor, DMSc, Aarhus University Hospital
    ClinicalTrials.gov Identifier:
    NCT05195515
    Other Study ID Numbers:
    • CONQUER
    First Posted:
    Jan 19, 2022
    Last Update Posted:
    Jan 19, 2022
    Last Verified:
    Jan 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Jørgen Bjerggaard Jensen, Professor, DMSc, Aarhus University Hospital
    Quality of Life
    Bladder Cancer
    Late effects
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Jan 19, 2022