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Completed

NCT Number: NCT03135444

PSA TOOL for Prostate Cancer Screening Discussions

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.

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Key information

Conditions

Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

40 year–69 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PSA TOOL

Behavioral

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

Revised PSA TOOL

Behavioral

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

Informal Interview

Behavioral

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

Primary outcomes

  1. Score from Perceived Usefulness scale

    Time frame: Up to 4 weeks after getting PSA TOOL

    scale will be summarized as means and standard deviations

  2. Score from Perceived Ease of Use scale

    Time frame: Up to 4 weeks after getting PSA TOOL

    scale will be summarized as means and standard deviations

  3. Change in Score from Pre-Test to Post-Test

    Time frame: Up to 30 minutes after Pre-Test

    The paired t-test will be used to compare the pre- and post- patient survey scores

Other outcomes

  1. Informal Interview

    Time frame: Up to 15 minutes after post test is performed

    Informal interviews will be done with patients and providers and assessed for themes

Sponsors and collaborators

Lead sponsor

Case Comprehensive Cancer Center

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
May 1, 2017
Registry last updated
May 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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