Health-Related Quality of Life in Patients With Bladder Cancer

February 1, 2012 updated by: David Latini

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

138

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Texas
      • Houston, Texas, United States, 77030
        • Dan L. Duncan Cancer Center at Baylor College of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Persons diagnosed with bladder cancer within 4 years of study entry

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Collection and examination of data on health-related quality of life and symptom management
Time Frame: Cross-sectional
Cross-sectional

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

David Latini

Investigators

  • Principal Investigator: David M. Latini, PhD, Baylor College of Medicine

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

July 1, 2011

Study Completion (Actual)

July 1, 2011

Study Registration Dates

First Submitted

August 29, 2008

First Submitted That Met QC Criteria

August 29, 2008

First Posted (Estimate)

September 1, 2008

Study Record Updates

Last Update Posted (Estimate)

February 2, 2012

Last Update Submitted That Met QC Criteria

February 1, 2012

Last Verified

February 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CDR0000600461
  • BCM-H-21350

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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