Clinical trial NCT03135444: PSA TOOL for Prostate Cancer Screening Discussions
Official title: Testing of a Brief Tool (PSA TOOL) for Prostate Cancer Screening Discussions in Primary Care Settings
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Prostate Cancer
Keywords: Screening
Shared Decision Making
Lead sponsor: Case Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2017-05-01
Enrollment: 95
Sex: MALE
Minimum age (years): 40
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
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.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Score from Perceived Usefulness scale
timeFrame: Up to 4 weeks after getting PSA TOOL
measure: Score from Perceived Ease of Use scale
timeFrame: Up to 4 weeks after getting PSA TOOL
measure: Change in Score from Pre-Test to Post-Test
timeFrame: Up to 30 minutes after Pre-Test
Secondary outcomes:
Other outcomes:
measure: Informal Interview
timeFrame: Up to 15 minutes after post test is performed
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic, Case Comprehensive Cancer Center
state: Ohio
Study officials:
affiliation: Cleveland Clinic, Case Comprehensive Cancer Center
name: Anita Misra-Hebert, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: