Quality of Life and Symptom Management in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

A Qualitative Study of Patients With Non-Invasive Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00772018
• Other study ID #: CDR0000600591
• Secondary ID: BCM-H-21570
• Status: Completed
• Phase: N/A
• First received: October 12, 2008
• Last updated: February 1, 2012
• Start date: May 2008
• Est. completion date: September 2010

Study information

• Verified date: February 2012
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: September 2010
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Observational Model: Ecologic or Community, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Dan L. Duncan Cancer Center at Baylor College of Medicine	Houston	Texas
United States	Veterans Affairs Medical Center - Houston	Houston	Texas

Sponsors (1)

Lead Sponsor	Collaborator
David Latini

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer	Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol.	One timepoint	No