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PSA TOOL for Prostate Cancer Screening Discussions

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PSA TOOL
Revised PSA TOOL
Informal Interview
Sponsored by
Case Comprehensive Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Prostate Cancer focused on measuring Screening, Shared Decision Making

Eligibility Criteria

40 Years - 69 Years (Adult, Older Adult)MaleAccepts 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

Sites / Locations

  • Cleveland Clinic, Case Comprehensive Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Provider Field Test

Patient test of revised PSA TOOL

Arm 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.

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.

Outcomes

Primary Outcome Measures

Score from Perceived Usefulness scale
scale will be summarized as means and standard deviations
Score from Perceived Ease of Use scale
scale will be summarized as means and standard deviations
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

Secondary Outcome Measures

Full Information

First Posted
April 27, 2017
Last Updated
May 9, 2018
Sponsor
Case Comprehensive Cancer Center
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1. Study Identification

Unique Protocol Identification Number
NCT03135444
Brief Title
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

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
December 13, 2017 (Actual)
Study Completion Date
April 23, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Case Comprehensive Cancer Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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: To pilot test a decision making tool, the PSA TOOL, for prostate cancer screening for usefulness and ease of use in primary care practices. To revise the PSA TOOL based upon provider and patient feedback. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
Screening, Shared Decision Making

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
95 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Provider Field Test
Arm Type
Experimental
Arm 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.
Arm Title
Patient test of revised PSA TOOL
Arm Type
Experimental
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
PSA TOOL
Intervention Description
Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.
Intervention Type
Behavioral
Intervention Name(s)
Revised PSA TOOL
Intervention Description
Patients will be given the revised PSA TOOL, after providers have given their initial feedback.
Intervention Type
Behavioral
Intervention Name(s)
Informal Interview
Intervention Description
Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
Primary Outcome Measure Information:
Title
Score from Perceived Usefulness scale
Description
scale will be summarized as means and standard deviations
Time Frame
Up to 4 weeks after getting PSA TOOL
Title
Score from Perceived Ease of Use scale
Description
scale will be summarized as means and standard deviations
Time Frame
Up to 4 weeks after getting PSA TOOL
Title
Change in Score from Pre-Test to Post-Test
Description
The paired t-test will be used to compare the pre- and post- patient survey scores
Time Frame
Up to 30 minutes after Pre-Test
Other Pre-specified Outcome Measures:
Title
Informal Interview
Description
Informal interviews will be done with patients and providers and assessed for themes
Time Frame
Up to 15 minutes after post test is performed

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anita Misra-Hebert, MD, MPH
Organizational Affiliation
Cleveland Clinic, Case Comprehensive Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cleveland Clinic, Case Comprehensive Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States

12. IPD Sharing Statement

Learn more about this trial

PSA TOOL for Prostate Cancer Screening Discussions

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