Health-Related Quality of Life in Patients With Bladder Cancer

Bladder Cancer Clinical Trial

Official title:

A CROSS-SECTIONAL STUDY OF PATIENT-REPORTED OUTCOMES FOR BLADDER CANCER PATIENTS WITH NON-INVASIVE DISEASE

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00744744
• Other study ID #: CDR0000600461
• Secondary ID: BCM-H-21350
• Status: Completed
• Phase: N/A
• First received: August 29, 2008
• Last updated: February 1, 2012
• Start date: May 2008
• Est. completion date: July 2011

Study information

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

Clinical Trial Summary

RATIONALE: Gathering information about quality of life in patients with cancer may improve the ability to plan treatment and may help patients live more comfortably.

PURPOSE: This clinical trial is studying health-related quality of life in patients with bladder cancer.

Description:

OBJECTIVES:

• To identify aspects of survivorship experience that differ by clinical risk (low risk vs high risk) in patients with non-invasive bladder cancer.

• To collect and examine data on health-related quality of life (HRQOL) and symptom management.

• To analyze differences in outcomes between genders, stage and grade of disease, and recency of diagnosis (new diagnosis vs ≥ 6 month diagnosis).

OUTLINE: Patients undergo a 45-minute telephone interview to assess their current medical condition and psychological functioning (i.e., bladder cancer treatment history, levels of depression and anxiety, quality of life, self-efficacy, and perceived social support). Patients complete a series of questionnaires including the Lepore social constraint measure; REACH social support measure; self-report inventories assessing patient communication, relationship style, illness intrusiveness, fear of recurrence, and social constraint; Impact of Events scale; Brief Symptom Index-18 and Global Severity Index; EORTC QLQ-C30 (general health-related quality of life); and EORTC QLC-BLS24 (disease-specific health-related quality of life).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: July 2011
• Est. primary completion date: July 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

DISEASE CHARACTERISTICS:

• Diagnosis of non-invasive bladder cancer within the past 4 years

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

Intervention

Other:
• informational intervention
Patient educational information
• questionnaire administration
Survey

Procedure:
• management of therapy complications
Survey
• psychosocial assessment and care
Survey
• quality-of-life assessment
Survey

Locations

Country	Name	City	State
United States	Dan L. Duncan Cancer Center at Baylor College of Medicine	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	Collection and examination of data on health-related quality of life and symptom management		Cross-sectional	No