Bladder Cancer Patient-Reported Outcomes

November 7, 2016 updated by: David Latini, Baylor College of Medicine

A Cross-Sectional Study Of Patient-Reported Outcomes For Bladder Cancer Patients With Non-Invasive Disease

The purpose of this study is to identify aspects of the bladder cancer (BlCa) survivorship experience that differ by clinical risk at diagnosis. The investigators will collect cross-sectional data from persons with BlCa to identify aspects of health-related quality of life (HRQOL) and symptom management. The study originally enrolled only nonmuscle-invasive bladder cancer survivors but has been expanded to include survivors with any stage disease. Information from this study will be used to develop a new patient education and counseling intervention.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

108

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
        • 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

Bladder cancer patients (all stages) recruited at hospitals affiliated with Baylor College of Medicine and MD Anderson Cancer Center and via the websites of bladder cancer survivor organizations

Description

Inclusion Criteria:

  • > 18 years
  • Diagnosed with BlCa within the past 4 years
  • Able to read, speak, and understand English
  • Able to provide informed consent.

Exclusion Criteria:

  • Younger than 18
  • Diagnosed BlCa longer than 4 years ago
  • Unable to read, speak, and understand English
  • Unable to provide informed consent.

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
1
Participants voluntarily completed a telephone interview using a questionnaire compiled using validated, patient-centered measures of cancer outcomes and psychosocial status.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Health-related quality of life as measured by the EORTC QLQ C30 and BLS24 (nonmuscle-invasive) or BLM30 (muscle-invasive or metastatic)
Time Frame: Duration of Study

Health-related quality of life as measured by the European Organization for Resarch and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ) C30 and BLS24 (that is, BLadder cancer Superficial, meaning nonmuscle-invasive) or BLM30 (BLadder cancer muscle-invasive or metastatic).

Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.
Duration of Study

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Illness intrusiveness
Time Frame: Duration of Study
Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.
Duration of Study
CaPSURE Fear of Recurrence
Time Frame: Duration of Study

The fear of recurrence measure was originally developed and validated for the Cancer of the Prostate Strategic Urologic Research Endeavor (CaPSURE) study.

Data are assessed at one time point only. Survey participants may be assessed at any point between diagnosis and 4 years post-diagnosis. The questions in the survey typically ask about health-related quality of life in the preceding 4 weeks.
Duration of Study

Collaborators and Investigators

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

Sponsor

Baylor College of Medicine

Collaborators

M.D. Anderson Cancer Center

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

July 1, 2007

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

November 1, 2016

Study Registration Dates

First Submitted

July 16, 2008

First Submitted That Met QC Criteria

March 19, 2010

First Posted (Estimate)

March 22, 2010

Study Record Updates

Last Update Posted (Estimate)

November 9, 2016

Last Update Submitted That Met QC Criteria

November 7, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SDU07-BlCa-PRO

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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