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Health-Related Quality of Life in Patients With Bladder Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00744744
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : February 2, 2012
Information provided by (Responsible Party):

Study Description
Brief Summary:

RATIONALE: Gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying health-related quality of life in patients with bladder cancer.

Condition or disease Intervention/treatment
Bladder Cancer Other: informational intervention Other: questionnaire administration Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment

Detailed Description:


  • To identify aspects of survivorship experience that differ by clinical risk (low risk vs high risk) in patients with non-invasive bladder cancer.
  • To collect and examine data on health-related quality of life (HRQOL) and symptom management.
  • To analyze differences in outcomes between genders, stage and grade of disease, and recency of diagnosis (new diagnosis vs ≥ 6 month diagnosis).

OUTLINE: Patients undergo a 45-minute telephone interview to assess their current medical condition and psychological functioning (i.e., bladder cancer treatment history, levels of depression and anxiety, quality of life, self-efficacy, and perceived social support). Patients complete a series of questionnaires including the Lepore social constraint measure; REACH social support measure; self-report inventories assessing patient communication, relationship style, illness intrusiveness, fear of recurrence, and social constraint; Impact of Events scale; Brief Symptom Index-18 and Global Severity Index; EORTC QLQ-C30 (general health-related quality of life); and EORTC QLC-BLS24 (disease-specific health-related quality of life).

Study Design

Study Type : Observational
Actual Enrollment : 138 participants
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Study Start Date : May 2008
Primary Completion Date : July 2011
Study Completion Date : July 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bladder Cancer
U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Survey Other: informational intervention
Patient educational information
Other: questionnaire administration
Procedure: management of therapy complications
Procedure: psychosocial assessment and care
Procedure: quality-of-life assessment

Outcome Measures

Primary Outcome Measures :
  1. Collection and examination of data on health-related quality of life and symptom management [ Time Frame: Cross-sectional ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Persons diagnosed with bladder cancer within 4 years of study entry


  • Diagnosis of non-invasive bladder cancer within the past 4 years


  • Not pregnant
  • Able to read, speak, and understand English


  • Not specified
Contacts and Locations

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): NCT00744744

United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
David Latini
Principal Investigator: David M. Latini, PhD Baylor College of Medicine
More Information

Responsible Party: David Latini, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00744744     History of Changes
Other Study ID Numbers: CDR0000600461
First Posted: September 1, 2008    Key Record Dates
Last Update Posted: February 2, 2012
Last Verified: February 2012

Keywords provided by David Latini, Baylor College of Medicine:
stage 0 bladder cancer

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