This trial is active, not recruiting.

Condition bladder neoplasms
Sponsor Baylor College of Medicine
Collaborator M.D. Anderson Cancer Center
Start date July 2007
End date August 2011
Trial size 400 participants
Trial identifier NCT01090388, SDU07-BlCa-PRO


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective cross-sectional
Participants voluntarily completed a telephone interview using a questionnaire compiled using validated, patient-centered measures of cancer outcomes and psychosocial status.

Primary Outcomes

Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)
time frame: Duration of Study

Secondary Outcomes

Illness intrusiveness
time frame: Duration of Study
CaPSURE Fear of Recurrence
time frame: Duration of Study

Eligibility Criteria

Male or female participants at least 18 years old.

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.

Additional Information

Official title A Cross-Sectional Study Of Patient-Reported Outcomes For Bladder Cancer Patients With Non-Invasive Disease
Principal investigator David M Latini, PhD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by Baylor College of Medicine.