PSA TOOL for Prostate Cancer Screening Discussions

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Prostate Cancer

Treatments: Behavioral: Informal Interview; Behavioral: Revised PSA TOOL; Behavioral: PSA TOOL

Study type: Interventional

Funder types: Other

Identifiers

NCT03135444

CASE3817

Details and patient eligibility

About

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.

Full 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.

Enrollment: 95 patients

Sex: Male

Ages: 40 to 69 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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95 participants in 2 patient groups

Provider Field Test

Experimental group

Description:

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.

Treatment:

Behavioral: Informal Interview

Behavioral: PSA TOOL

Patient test of revised PSA TOOL

Experimental group

Description:

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.

Treatment:

Behavioral: Informal Interview

Behavioral: Revised PSA TOOL