PSA TOOL for Prostate Cancer Screening Discussions

NCT03135444 | Completed

• 1 other identifier: CASE3817
• Study Type: interventional
• Target: 95
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer

Keywords

Screening; Shared Decision Making

Outcome Measures

Primary Outcomes (3)

• Score from Perceived Usefulness scale

  scale will be summarized as means and standard deviations

  Up to 4 weeks after getting PSA TOOL

• Score from Perceived Ease of Use scale

  scale will be summarized as means and standard deviations

  Up to 4 weeks after getting PSA TOOL

• 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

  Up to 30 minutes after Pre-Test

Other Outcomes (1)

• Informal Interview

  Up to 15 minutes after post test is performed

Study Arms (2)

Provider Field Test

EXPERIMENTAL

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.

Behavioral: PSA TOOL; Behavioral: Informal Interview

Patient test of revised PSA TOOL

EXPERIMENTAL

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.

Behavioral: Revised PSA TOOL; Behavioral: Informal Interview

Interventions

PSA TOOL BEHAVIORAL

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

Provider Field Test

Revised PSA TOOL BEHAVIORAL

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

Patient test of revised PSA TOOL

Informal Interview BEHAVIORAL

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

Patient test of revised PSA TOOL; Provider Field Test

Eligibility Criteria

• Age: 40 Years - 69 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Not a patient or provider of the Cleveland Clinic Health System

Sponsors & Collaborators

• Case Comprehensive Cancer Center: lead

Study Sites (1)

Cleveland Clinic, Case Comprehensive Cancer Center

Cleveland, Ohio, 44195, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases

Study Officials

• Anita Misra-Hebert, MD, MPH

  Cleveland Clinic, Case Comprehensive Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 1, 2017
• Study Start: May 2, 2017
• Primary Completion: December 13, 2017
• Study Completion: April 23, 2018
• Last Updated: May 11, 2018

Record last verified: 2018-05

Locations

US (1)