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PSA TOOL for Prostate Cancer Screening Discussions

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03135444
Enrollment
95
Registered
2017-05-01
Start date
2017-05-02
Completion date
2018-04-23
Last updated
2018-05-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Prostate Cancer

Keywords

Screening, Shared Decision Making

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.

Interventions

BEHAVIORALPSA TOOL

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

BEHAVIORALRevised PSA TOOL

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

BEHAVIORALInformal Interview

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

Sponsors

Case Comprehensive Cancer Center
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE

Intervention model description

Initially, health care providers will give feedback on the tool. The tool will be revised and the second segment of the study will be to give the revised tool to patients with pre- and post-tests which measure changes in prostate cancer screening knowledge.

Eligibility

Sex/Gender
MALE
Age
40 Years to 69 Years
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Score from Perceived Usefulness scaleUp to 4 weeks after getting PSA TOOLscale will be summarized as means and standard deviations
Score from Perceived Ease of Use scaleUp to 4 weeks after getting PSA TOOLscale will be summarized as means and standard deviations
Change in Score from Pre-Test to Post-TestUp to 30 minutes after Pre-TestThe paired t-test will be used to compare the pre- and post- patient survey scores

Other

MeasureTime frameDescription
Informal InterviewUp to 15 minutes after post test is performedInformal interviews will be done with patients and providers and assessed for themes

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026