Bladder Cancer Patient-Reported Outcomes

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
M.D. Anderson Cancer Center
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT01090388
First received: July 16, 2008
Last updated: July 24, 2013
Last verified: July 2013
  Purpose

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
Bladder Neoplasms

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic) [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

    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:
  • Illness intrusiveness [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]
    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.

  • CaPSURE Fear of Recurrence [ Time Frame: Duration of Study ] [ Designated as safety issue: No ]

    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.



Estimated Enrollment: 400
Study Start Date: July 2007
Estimated Study Completion Date: December 2014
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Survey cohort

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Bladder cancer patients (all stages) recruited at hospitals affiliated with Baylor College of Medicine and MD Anderson Cancer Center and via the websites of bladder cancer survivor organizations

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01090388

Locations
United States, Texas
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
  More Information

Publications:
Responsible Party: David Latini, Adjunct Assistant Professor of Urology, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT01090388     History of Changes
Other Study ID Numbers: SDU07-BlCa-PRO
Study First Received: July 16, 2008
Last Updated: July 24, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:
Cross-sectional survey
Health-related quality of life
Symptom management

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on September 22, 2014