Prostate Cancer Utilities and Cost-Effectiveness Analysis

August 28, 2017 updated by: University of Chicago
The purpose of this study is to help doctors and patients make better decisions about prostate cancer treatment. This research is being done because we do not know how patient preferences for health states related to prostate cancer affect the final treatment decision.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The goal of this project is to incorporate patients' preferences into a previously developed prostate cancer treatment decision-model and to understand the implications for doing so for cost-effectiveness analysis. To do this, it is first necessary to obtain patient utility scores (i.e., patient preference weights). To do this we will perform a survey of patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand the patients' individual evaluations of treatment-related health studies. We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer.

Study Type

Observational

Enrollment (Actual)

481

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
    • Illinois
      • Chicago, Illinois, United States, 60637
        • The University of Chicago

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

Male

Sampling Method

Probability Sample

Study Population

Patients visiting the urology clinic at the University of Chicago.

Description

Inclusion Criteria:

  • Patients undergoing prostate biopsy

Exclusion Criteria:

  • Women and children will be excluded, as prostate cancer occurs in men only
  • Diagnosis of dementia

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
Prostate biopsies
Males undergoing prostate biopsies
Behavioral: Survey, interview
A survey is administered to patients visiting the urology clinic to undergo prostate biopsies to validate a method of utility assessment, and understand patients' individual evaluations of treatment-related health states. Medical records will also be reviewed 00 days after the survey was administered to determine whether this data reflects actual treatment decisions.
Behavioral: patient utility scores (i.e. patient preference weights)
comparison of patient preferences

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Utility scores for treatment outcomes
Time Frame: 90 days after enrollment
Patient utility scores (i.e. patient preference weights) are calculated using survery data will determine which prostate cancer treatment would be most cost-effective for each subject. Patients will be contacted by phone and patient records will be reviewed 90 days after the survey has been completed to determine whether this data reflects actual treatment decisions.
90 days after enrollment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Anxiety levels
Time Frame: 90 days after enrollment
We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer.
90 days after enrollment

Collaborators and Investigators

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

Sponsor

University of Chicago

Investigators

  • Principal Investigator: David Meltzer, M.D., Ph.D., University Of Chicago

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

January 1, 2004

Primary Completion (Actual)

February 1, 2011

Study Completion (Actual)

February 1, 2013

Study Registration Dates

First Submitted

September 12, 2005

First Submitted That Met QC Criteria

September 12, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

August 30, 2017

Last Update Submitted That Met QC Criteria

August 28, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12843B

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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