CompletedNot Applicable

PSA TOOL for Prostate Cancer Screening Discussions

United States95 participantsStarted 2017-05-02

Plain-language 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.

Who can participate

Age range

40 Years – 69 Years

Sex

MALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Score from Perceived Usefulness scale

Timeframe: Up to 4 weeks after getting PSA TOOL

Score from Perceived Ease of Use scale

Timeframe: Up to 4 weeks after getting PSA TOOL

Change in Score from Pre-Test to Post-Test

Timeframe: Up to 30 minutes after Pre-Test

Trial details

NCT IDNCT03135444

SponsorCase Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2017-12-13

View on ClinicalTrials.gov More Prostate Cancer trials