Health-Related Quality of Life in Patients With Bladder Cancer
|ClinicalTrials.gov Identifier: NCT00744744|
Recruitment Status : Completed
First Posted : September 1, 2008
Last Update Posted : February 2, 2012
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.
|Condition or disease||Intervention/treatment|
|Bladder Cancer||Other: informational intervention Other: questionnaire administration Procedure: management of therapy complications Procedure: psychosocial assessment and care Procedure: quality-of-life assessment|
- 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).
|Study Type :||Observational|
|Actual Enrollment :||138 participants|
|Observational Model:||Ecologic or Community|
|Official Title:||A CROSS-SECTIONAL STUDY OF PATIENT-REPORTED OUTCOMES FOR BLADDER CANCER PATIENTS WITH NON-INVASIVE DISEASE|
|Study Start Date :||May 2008|
|Actual Primary Completion Date :||July 2011|
|Actual Study Completion Date :||July 2011|
Other: informational intervention
Patient educational informationOther: questionnaire administration
SurveyProcedure: management of therapy complications
SurveyProcedure: psychosocial assessment and care
SurveyProcedure: quality-of-life assessment
- Collection and examination of data on health-related quality of life and symptom management [ Time Frame: Cross-sectional ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00744744
|United States, Texas|
|Dan L. Duncan Cancer Center at Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||David M. Latini, PhD||Baylor College of Medicine|