PSA TOOL for Prostate Cancer Screening Discussions

Prostate Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03135444
• Other study ID #: CASE3817
• Status: Completed
• Phase: N/A
• Start date: May 2, 2017
• Est. completion date: April 23, 2018

Study information

• Verified date: May 2018
• Source: Case Comprehensive Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 95
• Est. completion date: April 23, 2018
• Est. primary completion date: December 13, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 40 Years to 69 Years

Eligibility

Inclusion Criteria:

Provider:

• 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:

• 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

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

Behavioral:
• PSA TOOL
Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.
• Revised PSA TOOL
Patients will be given the revised PSA TOOL, after providers have given their initial feedback.
• Informal Interview
Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.

Locations

Country	Name	City	State
United States	Cleveland Clinic, Case Comprehensive Cancer Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Case Comprehensive Cancer Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Informal Interview	Informal interviews will be done with patients and providers and assessed for themes	Up to 15 minutes after post test is performed
Primary	Score from Perceived Usefulness scale	scale will be summarized as means and standard deviations	Up to 4 weeks after getting PSA TOOL
Primary	Score from Perceived Ease of Use scale	scale will be summarized as means and standard deviations	Up to 4 weeks after getting PSA TOOL
Primary	Change in Score from Pre-Test to Post-Test	The paired t-test will be used to compare the pre- and post- patient survey scores	Up to 30 minutes after Pre-Test