Health-Related Quality of Life in Patients With Bladder Cancer

Completed

• Conditions: Bladder Cancer
• Interventions: Other: informational intervention; Other: questionnaire administration; Procedure: management of therapy complications; Procedure: psychosocial assessment and care; Procedure: quality-of-life assessment

• Registration Number: NCT00744744
• Lead Sponsor: David Latini

Brief 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.

Detailed 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).

Study Timeline

• Study Start: 2008-05
• Study First Submitted: 2008-08-29
• Study First Submitted QC: 2008-08-29
• Study First Posted: 2008-09-01
• Primary Completion: 2011-07
• Study Completion: 2011-07
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-01
• Last Update Posted: 2012-02-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Survey	informational intervention	-
Survey	questionnaire administration	-
Survey	management of therapy complications	-
Survey	psychosocial assessment and care	-
Survey	quality-of-life assessment	-

Primary Outcome Measures

Name	Time	Method
Collection and examination of data on health-related quality of life and symptom management	Cross-sectional

Trial Locations

Locations (1)

Dan L. Duncan Cancer Center at Baylor College of Medicine; 🇺🇸 Houston, Texas, United States