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Bladder Cancer Patient-Reported Outcomes

Sponsor
Baylor College of Medicine (Other)
Overall Status
Completed
CT.gov ID
NCT01090388
Collaborator
M.D. Anderson Cancer Center (Other)
108
Enrollment
1
Location
112.1
Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship experience that differ by clinical risk at diagnosis. The investigators will collect cross-sectional data from persons with BlCa to identify aspects of health-related quality of life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. Information from this study will be used to develop a new patient education and counseling intervention.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    108 participants
    Observational Model:
    Cohort
    Time Perspective:
    Cross-Sectional
    Official Title:
    A Cross-Sectional Study Of Patient-Reported Outcomes For Bladder Cancer Patients With Non-Invasive Disease
    Study Start Date :
    Jul 1, 2007
    Actual Primary Completion Date :
    Aug 1, 2011
    Actual Study Completion Date :
    Nov 1, 2016

    Arms and Interventions

    Arm Intervention/Treatment
    1

    Participants voluntarily completed a telephone interview using a questionnaire compiled using validated, patient-centered measures of cancer outcomes and psychosocial status.

    Outcome Measures

    Primary Outcome Measures

    1. Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic) [Duration of Study]

      Health-related quality of life as measured by the European Organization for Resarch and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and BLS24 (that is, BLadder cancer Superficial, meaning nonmuscle-invasive) or BLM30 (BLadder cancer muscle-invasive or metastatic). Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

    Secondary Outcome Measures

    1. Illness intrusiveness [Duration of Study]

      Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

    2. CaPSURE Fear of Recurrence [Duration of Study]

      The fear of recurrence measure was originally developed and validated for the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) study. Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

    Eligibility Criteria

    Criteria

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

    • 18 years

    • Diagnosed with BlCa within the past 4 years

    • Able to read, speak, and understand English

    • Able to provide informed consent.

    Exclusion Criteria:

    • Younger than 18

    • Diagnosed BlCa longer than 4 years ago

    • Unable to read, speak, and understand English

    • Unable to provide informed consent.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Baylor College of Medicine Houston Texas United States 77030

    Sponsors and Collaborators

    • Baylor College of Medicine
    • M.D. Anderson Cancer Center

    Investigators

    • Principal Investigator: David M Latini, PhD, Baylor College of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    David Latini, Associate Professor of Urology, Baylor College of Medicine
    ClinicalTrials.gov Identifier:
    NCT01090388
    Other Study ID Numbers:
    • SDU07-BlCa-PRO
    First Posted:
    Mar 22, 2010
    Last Update Posted:
    Nov 9, 2016
    Last Verified:
    Nov 1, 2016
    Keywords provided by David Latini, Associate Professor of Urology, Baylor College of Medicine
    Cross-sectional survey
    Health-related quality of life
    Symptom management
    Additional relevant MeSH terms:
    Urinary Bladder Neoplasms

    Study Results

    No Results Posted as of Nov 9, 2016