Health-Related Quality of Life in Patients With Bladder Cancer

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
David Latini, Baylor College of Medicine
ClinicalTrials.gov Identifier:
NCT00744744
First received: August 29, 2008
Last updated: February 1, 2012
Last verified: February 2012
  Purpose

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

Study Type: Observational
Study Design: Observational Model: Ecologic or Community
Time Perspective: Cross-Sectional
Official Title: A CROSS-SECTIONAL STUDY OF PATIENT-REPORTED OUTCOMES FOR BLADDER CANCER PATIENTS WITH NON-INVASIVE DISEASE

Resource links provided by NLM:


Further study details as provided by Baylor College of Medicine:

Primary Outcome Measures:
  • Collection and examination of data on health-related quality of life and symptom management [ Time Frame: Cross-sectional ] [ Designated as safety issue: No ]

Enrollment: 138
Study Start Date: May 2008
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Survey Other: informational intervention
Patient educational information
Other: questionnaire administration
Survey
Procedure: management of therapy complications
Survey
Procedure: psychosocial assessment and care
Survey
Procedure: quality-of-life assessment
Survey

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Persons diagnosed with bladder cancer within 4 years of study entry

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00744744

Locations
United States, Texas
Dan L. Duncan Cancer Center at Baylor College of Medicine
Houston, Texas, United States, 77030
Sponsors and Collaborators
David Latini
Investigators
Principal Investigator: David M. Latini, PhD Baylor College of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: David Latini, Assistant Professor, Baylor College of Medicine
ClinicalTrials.gov Identifier: NCT00744744     History of Changes
Other Study ID Numbers: CDR0000600461, BCM-H-21350
Study First Received: August 29, 2008
Last Updated: February 1, 2012
Health Authority: United States: Federal Government

Keywords provided by Baylor College of Medicine:
stage 0 bladder cancer

Additional relevant MeSH terms:
Urinary Bladder Neoplasms
Urologic Neoplasms
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Urinary Bladder Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on April 17, 2014