Bladder Cancer Patient-Reported Outcomes

Bladder Neoplasms 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: NCT01090388
• Other study ID #: SDU07-BlCa-PRO
• Status: Completed
• Phase: N/A
• First received: July 16, 2008
• Last updated: November 7, 2016
• Start date: July 2007
• Est. completion date: November 2016

Study information

• Verified date: November 2016
• Source: Baylor College of Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: November 2016
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Bladder Neoplasms
• Urinary Bladder Neoplasms

Locations

Country	Name	City	State
United States	Baylor College of Medicine	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Baylor College of Medicine	M.D. Anderson Cancer Center

Country where clinical trial is conducted

United States, 

References & Publications (3)

Kowalkowski MA, Chandrashekar A, Amiel GE, Lerner SP, Wittmann DA, Latini DM, Goltz HH. Examining sexual dysfunction in non-muscle-invasive bladder cancer: results of cross-sectional mixed-methods research. Sex Med. 2014 Aug;2(3):141-51. doi: 10.1002/sm2. — View Citation

Kowalkowski MA, Goltz HH, Petersen NJ, Amiel GE, Lerner SP, Latini DM. Educational opportunities in bladder cancer: increasing cystoscopic adherence and the availability of smoking-cessation programs. J Cancer Educ. 2014 Dec;29(4):739-45. doi: 10.1007/s13 — View Citation

Latini DM, Lerner SP, Wade SW, Lee DW, Quale DZ. Bladder cancer detection, treatment and outcomes: opportunities and challenges. Urology. 2010 Feb;75(2):334-9. doi: 10.1016/j.urology.2009.09.051. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)	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.	Duration of Study	No
Secondary	Illness intrusiveness	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.	Duration of Study	No
Secondary	CaPSURE Fear of Recurrence	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.	Duration of Study	No