PSA TOOL for Prostate Cancer Screening Discussions

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

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.

Study Overview

• Status: Completed
• Conditions: Prostate Cancer
• Intervention / Treatment: Behavioral: PSA TOOL; Behavioral: Informal Interview; Behavioral: Revised PSA TOOL

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.

• Study Type: Interventional
• Enrollment (Actual): 95
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Ohio
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic, Case Comprehensive Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 69 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Male

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Provider Field Test; 15 providers will be given an initial version of the PSA TOOL, over a 4 week period, they will be able to provide feedback on the tool. This will be used to revise the screening decision aid. Informal interviews with providers will also be conducted by a member of the study team to obtain feedback about ease of use and usefulness of the tool.	Behavioral: PSA TOOL; Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.; Behavioral: Informal Interview; Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
Experimental: Patient test of revised PSA TOOL; 150 patients will be asked to use the revised PSA TOOL. Pre- and Post-tests will be given to see if the tool changed the knowledge that patients have an option to be screened for prostate cancer and of specific factors to be considered in the screening decision. Informal interviews with patients who are exposed to the tool will also be conducted by a member of the study team to obtain feedback on issues addressed by the survey questions.	Behavioral: Informal Interview; Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.; Behavioral: Revised PSA TOOL; Patients will be given the revised PSA TOOL, after providers have given their initial feedback.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Score from Perceived Usefulness scale	scale will be summarized as means and standard deviations	Up to 4 weeks after getting PSA TOOL
Score from Perceived Ease of Use scale	scale will be summarized as means and standard deviations	Up to 4 weeks after getting PSA TOOL
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Informal Interview	Informal interviews will be done with patients and providers and assessed for themes	Up to 15 minutes after post test is performed

Collaborators and Investigators

• Sponsor: Case Comprehensive Cancer Center
• Investigators: Principal Investigator: Anita Misra-Hebert, MD, MPH, Cleveland Clinic, Case Comprehensive Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): May 2, 2017
• Primary Completion (Actual): December 13, 2017
• Study Completion (Actual): April 23, 2018

Study Registration Dates

• First Submitted: April 27, 2017
• First Submitted That Met QC Criteria: April 27, 2017
• First Posted (Actual): May 1, 2017

Study Record Updates

• Last Update Posted (Actual): May 11, 2018
• Last Update Submitted That Met QC Criteria: May 9, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Screening; Shared Decision Making
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Male; Prostatic Diseases; Prostatic Neoplasms
• Other Study ID Numbers: CASE3817

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No