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Clinical Trials/NCT03135444
NCT03135444
Completed
Not Applicable

Testing of a Brief Tool (PSA TOOL) for Prostate Cancer Screening Discussions in Primary Care Settings

Case Comprehensive Cancer Center1 site in 1 country95 target enrollmentMay 2, 2017
ConditionsProstate Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Case Comprehensive Cancer Center
Enrollment
95
Locations
1
Primary Endpoint
Score from Perceived Usefulness scale
Status
Completed
Last Updated
7 years ago

Overview

Brief Summary

The study team created a tool to help identify patients who may benefit from shared decision making in the primary care setting. This tool is a guide to aid in decision making for prostate cancer screening. The team proposes the topics to be discussed in the screening conversation include the risk for developing prostate cancer based upon age, race/ethnicity, family history of prostate cancer, history of previous digital rectal exam, and history of previous prostate specific antigen (PSA) as well as self-reported health status and preferences for treatment. The team now proposes 1) testing this tool first for ease of use in primary care clinics 2) revising this tool based upon feedback from patients and providers, then 3) testing this tool for effectiveness in improving patient knowledge that they have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision.

Detailed Description

Objectives: 1. To pilot test a decision making tool, the PSA TOOL, for prostate cancer screening for usefulness and ease of use in primary care practices. 2. To revise the PSA TOOL based upon provider and patient feedback. 3. To assess patient knowledge about the option to be screened for prostate cancer and factors to consider in the prostate cancer screening decision before and after use of the tool. Study Design: This protocol is for field testing of a brief tool to improve prostate cancer screening discussions that occur at previously scheduled primary care outpatient visits.

Registry
clinicaltrials.gov
Start Date
May 2, 2017
End Date
April 23, 2018
Last Updated
7 years ago
Study Type
Interventional
Study Design
Sequential
Sex
Male

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Provider at selected primary care practices in the Cleveland Clinic Health System
  • Willing to utilize a guide to aid in decision making for prostate cancer screening
  • Patient of participating Cleveland Clinic primary care provider who is scheduled for a routine appointment with the provider

Exclusion Criteria

  • Not a patient or provider of the Cleveland Clinic Health System

Outcomes

Primary Outcomes

Score from Perceived Usefulness scale

Time Frame: Up to 4 weeks after getting PSA TOOL

scale will be summarized as means and standard deviations

Score from Perceived Ease of Use scale

Time Frame: Up to 4 weeks after getting PSA TOOL

scale will be summarized as means and standard deviations

Change in Score from Pre-Test to Post-Test

Time Frame: Up to 30 minutes after Pre-Test

The paired t-test will be used to compare the pre- and post- patient survey scores

Study Sites (1)

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