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

History of Changes

Tracking Information

First Received Date ^ICMJE

October 12, 2008

Last Updated Date

February 1, 2012

Start Date ^ICMJE

May 2008

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

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 ]

Change History

Complete list of historical versions of study NCT00772018 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Not Provided

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Quality of Life and Symptom Management in Patients With Bladder Cancer

Official Title ^ICMJE

A Qualitative Study of Patients With Non-Invasive Bladder Cancer

Brief 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.

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 ^ICMJE

Observational

Study Design ^ICMJE

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

Target Follow-Up Duration

Not Provided

Biospecimen

Not Provided

Sampling Method

Non-Probability Sample

Study Population

Urology specialty clinic

Condition ^ICMJE

Bladder Cancer

Intervention ^ICMJE

Not Provided

Study Group/Cohort (s)

Not Provided

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

September 2010

Primary Completion Date

September 2010 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00772018

Other Study ID Numbers ^ICMJE

CDR0000600591, BCM-H-21570

Has Data Monitoring Committee

Responsible Party

David Latini, Baylor College of Medicine

Study Sponsor ^ICMJE

David Latini

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

David M. Latini, PhD

Baylor College of Medicine

Information Provided By

Baylor College of Medicine

Verification Date

February 2012

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

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