Quality of Life and Symptom Management in Patients With Bladder Cancer - Full Text View

Sponsor:	David Latini
Information provided by (Responsible Party):	David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00772018

Purpose

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.

Condition
Bladder Cancer

Study Type:	Observational
Study Design:	Observational Model: Ecologic or Community Time Perspective: Cross-Sectional
Official Title:	A Qualitative Study of Patients With Non-Invasive Bladder Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: bladder cancer

MedlinePlus related topics: Bladder Cancer Cancer Palliative Care

U.S. FDA Resources

Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:

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.

Enrollment:	28
Study Start Date:	May 2008
Study Completion Date:	September 2010
Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

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.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Urology specialty clinic

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00772018

Locations

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

Sponsors and Collaborators

David Latini

Investigators

Principal Investigator:

David M. Latini, PhD

Baylor College of Medicine

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	David Latini, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier:	NCT00772018 History of Changes
Other Study ID Numbers:	CDR0000600591, BCM-H-21570
Study First Received:	October 12, 2008
Last Updated:	February 1, 2012
Health Authority:	United States: Institutional Review Board

Keywords provided by Baylor College of Medicine:

stage 0 bladder cancer

Additional relevant MeSH terms:

Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site

Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on February 09, 2012