Bladder Cancer Patient-Reported Outcomes

Completed

• Conditions: Bladder Neoplasms

• Registration Number: NCT01090388
• Lead Sponsor: Baylor College of Medicine

Brief Summary

The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship experience that differ by clinical risk at diagnosis. The investigators will collect cross-sectional data from persons with BlCa to identify aspects of health-related quality of life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. Information from this study will be used to develop a new patient education and counseling intervention.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2008-07-16
• Study First Submitted QC: 2010-03-19
• Study First Posted: 2010-03-22
• Primary Completion: 2011-08
• Status Verified: 2016-11
• Study Completion: 2016-11
• Last Update Submitted: 2016-11-07
• Last Update Posted: 2016-11-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

Inclusion Criteria

• > 18 years
• Diagnosed with BlCa within the past 4 years
• Able to read, speak, and understand English
• Able to provide informed consent.

Exclusion Criteria

• Younger than 18
• Diagnosed BlCa longer than 4 years ago
• Unable to read, speak, and understand English
• Unable to provide informed consent.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)	Duration of Study	Health-related quality of life as measured by the European Organization for Resarch and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and BLS24 (that is, BLadder cancer Superficial, meaning nonmuscle-invasive) or BLM30 (BLadder cancer muscle-invasive or metastatic).; Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

Secondary Outcome Measures

Name	Time	Method
Illness intrusiveness	Duration of Study	Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.
CaPSURE Fear of Recurrence	Duration of Study	The fear of recurrence measure was originally developed and validated for the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) study.; Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.

Trial Locations

Locations (1)

Baylor College of Medicine; 🇺🇸 Houston, Texas, United States