Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Quality of Life and Symptom Management in Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00772018
First received: October 12, 2008
Last updated: February 1, 2012
Last verified: February 2012

October 12, 2008
February 1, 2012
May 2008
September 2010   (final data collection date for primary outcome measure)
Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer [ Time Frame: One timepoint ] [ Designated as safety issue: No ]
Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol.
  • Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer [ Designated as safety issue: No ]
  • Feedback on data collection methods [ Designated as safety issue: No ]
  • Identification of physical and psychological factors related to decrements in HRQOL [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00772018 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Quality of Life and Symptom Management in Patients With Bladder Cancer
A Qualitative Study of Patients With Non-Invasive Bladder Cancer

RATIONALE: Learning about quality of life and symptom management in patients with bladder cancer may help doctors learn about the effects of treatment and plan the best treatment.

PURPOSE: This clinical trial is studying of quality of life and symptom management in patients with bladder cancer.

OBJECTIVES:

Primary

  • To identify aspects of health-related quality of life (HRQOL) and symptom management in patients with non-invasive, low- or high-risk bladder cancer.
  • To obtain feedback on data collection methods to enhance acceptability in these patients.

OUTLINE: Patients undergo a 10-minute screening in person or by phone to obtain demographic data and medical information (e.g., bladder cancer diagnosis and treatment history). Additional information is obtained from the clinical databases at the Baylor College of Medicine and the Michael E. DeBakey Veterans Affairs Medical Center. Patients who are eligible for the study are added to a waiting list for 1 of 4 focus groups based on disease status (high-risk or low-risk non-invasive bladder cancer) and gender. Patients participate in a 1.5- to 2-hour focus group discussion about the impact of bladder cancer on their quality of life and relationships. Patients receive information about community and Internet-based resources at the end of each group session.

Observational
Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Not Provided
Not Provided
Non-Probability Sample

Urology specialty clinic

Bladder Cancer
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
28
September 2010
September 2010   (final data collection date for primary outcome measure)

DISEASE CHARACTERISTICS:

  • Diagnosis of bladder cancer within the past 4 years

    • Non-invasive disease
    • Low- or high-risk disease
  • Recruited from patients at the Baylor College of Medicine Scott Department of Urology clinics, the Michael E. DeBakey Veteran Affairs Medical Center, and the Urology Clinic at MD Anderson Cancer Center OR from participants at a community event

PATIENT CHARACTERISTICS:

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

PRIOR CONCURRENT THERAPY:

  • Not specified
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00772018
CDR0000600591, BCM-H-21570
No
David Latini, Baylor College of Medicine
David Latini
Not Provided
Principal Investigator: David M. Latini, PhD Baylor College of Medicine
Baylor College of Medicine
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP