Quality of Life and Symptom Management in Patients With Bladder Cancer

February 1, 2012 updated by: David Latini

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.

Study Overview

Status

Completed

Conditions

Detailed 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.

Study Type

Observational

Enrollment (Actual)

28

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Veterans Affairs Medical Center - Houston
      • Houston, Texas, United States, 77030
        • Dan L. Duncan Cancer Center at Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Urology specialty clinic

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life (HRQOL) and symptom management in patients with bladder cancer
Time Frame: One timepoint
Study is a retrospective qualitative study of nonmuscle-invasive bladder cancer patients using a semi-structured interview protocol.
One timepoint

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Latini

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

September 1, 2010

Study Registration Dates

First Submitted

October 12, 2008

First Submitted That Met QC Criteria

October 12, 2008

First Posted (Estimate)

October 15, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000600591
  • BCM-H-21570

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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