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OpenTrials
Completed

NCT Number: NCT00744744

Health-Related Quality of Life in Patients With Bladder Cancer

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.

Completed

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dan L. Duncan Cancer Center at Baylor College of Medicine

Houston, Texas, 77030, United States

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

DISEASE CHARACTERISTICS:

  • Diagnosis of non-invasive bladder cancer within the past 4 years

PATIENT CHARACTERISTICS:

  • Not pregnant
  • Able to read, speak, and understand English

PRIOR CONCURRENT THERAPY:

  • Not specified

Treatment and study plan

Informational intervention

Other

Patient educational information

Questionnaire Administration

Other

Survey

management of therapy complications

Procedure

Survey

psychosocial assessment and care

Procedure

Survey

quality-of-life assessment

Procedure

Survey

Primary outcomes

  1. Collection and examination of data on health-related quality of life and symptom management

    Time frame: Cross-sectional

Sponsors and collaborators

Lead sponsor

David Latini

Other

Registry information

Official study title

A CROSS-SECTIONAL STUDY OF PATIENT-REPORTED OUTCOMES FOR BLADDER CANCER PATIENTS WITH NON-INVASIVE DISEASE

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Sep 1, 2008
Registry last updated
Feb 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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