PSA TOOL for Prostate Cancer Screening Discussions

NCT ID: NCT03135444

Last Updated: 2018-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 95 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-02
• Study Completion Date: 2018-04-23

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.

Conditions

Prostate Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

PSA TOOL

Intervention Type: BEHAVIORAL

Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.

Informal Interview

Intervention Type: BEHAVIORAL

Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.

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.

Group Type: EXPERIMENTAL

Revised PSA TOOL

Intervention Type: BEHAVIORAL

Patients will be given the revised PSA TOOL, after providers have given their initial feedback.

Informal Interview

Intervention Type: BEHAVIORAL

Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.

Interventions

PSA TOOL

Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.

Intervention Type: BEHAVIORAL

Revised PSA TOOL

Patients will be given the revised PSA TOOL, after providers have given their initial feedback.

Intervention Type: BEHAVIORAL

Informal Interview

Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

Case Comprehensive Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Anita Misra-Hebert, MD, MPH

Role: PRINCIPAL_INVESTIGATOR

Cleveland Clinic, Case Comprehensive Cancer Center

Locations

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, United States

Countries

United States

Other Identifiers

CASE3817

Identifier Type: -

Identifier Source: org_study_id