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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 23, 2014