Prostate Cancer Utilities and Cost-Effectiveness Analysis

Prostate Cancer Clinical Trial

Official title:

Prostate Cancer Utilities and Cost-Effectiveness Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00203918
• Other study ID #: 12843B
• Status: Completed
• Phase: N/A
• First received: September 12, 2005
• Last updated: August 28, 2017
• Start date: January 2004
• Est. completion date: February 2013

Study information

• Verified date: August 2017
• Source: University of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 481
• Est. completion date: February 2013
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients undergoing prostate biopsy

Exclusion Criteria:

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

• Diagnosis of dementia

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• patient utility scores (i.e. patient preference weights)
comparison of patient preferences

Locations

Country	Name	City	State
United States	The University of Chicago	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
University of Chicago

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Utility scores for treatment outcomes	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	Anxiety levels	We will also ask patients questions relating to their anxiety levels concerning the possible diagnosis of prostate cancer.	90 days after enrollment