Prostate CancerNCT03135444
PSA TOOL for Prostate Cancer Screening Discussions
A study testing PSA TOOL, Revised PSA TOOL and Informal Interview in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 69 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- PSA TOOL, Revised PSA TOOL and Informal Interview
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 95 participants
- Where
- 1 siteUnited States
- Study dates
- 2 May 2017to 23 Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 69 years
- Men only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Not a patient or provider of the Cleveland Clinic Health System
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic, Case Comprehensive Cancer Center
Cleveland, Ohio, 44195
About this study
Official title: Testing of a Brief Tool (PSA TOOL) for Prostate Cancer Screening Discussions in Primary Care Settings
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.
Read the 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.
- Conditions
- Prostate Cancer
- Being tested
- PSA TOOL, Revised PSA TOOL, Informal Interview
- Keywords
- Screening, Shared Decision Making
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PSA TOOLBehavioural
Providers will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool.
Revised PSA TOOLBehavioural
Patients will be given the revised PSA TOOL, after providers have given their initial feedback.
Informal InterviewBehavioural
Both patients and providers will have informal interviews with the study team to get feedback on the survey taking process.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Revised PSA TOOL; Behavioral: Informal Interview |
What is being measured
The primary outcome is the main question the study is designed to answer.
Score from Perceived Usefulness scale
scale will be summarized as means and standard deviations
Measured: Up to 4 weeks after getting PSA TOOL
Score from Perceived Ease of Use scale
scale will be summarized as means and standard deviations
Measured: 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
Measured: Up to 30 minutes after Pre-Test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2017
- Study start2 May 2017
- Primary completion13 Dec 2017
- Study completion23 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 95 participants (actual)
Sponsor and investigators
- Lead sponsor
- Case Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anita Misra-Hebert, MD, MPH, Principal investigator, Cleveland Clinic, Case Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03135444
- Sponsor's protocol ID
- CASE3817
- Status last verified
- May 2018
- First submitted
- 27 Apr 2017
- Last updated
- 11 May 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Testing of a Brief Tool (PSA TOOL) for Prostate Cancer Screening Discussions in Primary Care Settings
- ClinicalTrials.gov ID
- NCT03135444
- Acronym / sponsor ID
- CASE3817
- Conditions
- Prostate Cancer
- Keywords
- Screening, Shared Decision Making
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 95 participants (actual)
- Lead sponsor
- Case Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 2 May 2017 (actual)
- Primary completion
- 13 Dec 2017 (actual)
- Study completion
- 23 Apr 2018 (actual)
- First posted
- 1 May 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Provider Field Test | Experimental | Behavioral: PSA TOOL, Behavioral: Informal Interview15 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. |
| Patient test of revised PSA TOOL | Experimental | Behavioral: Revised PSA TOOL, Behavioral: Informal Interview150 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. |
Who may qualify
- Ages
- 40 to 69 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 of participating Cleveland Clinic primary care provider who is scheduled for a routine appointment with the provider
Key exclusion criteria (1 listed)
- Not a patient or provider of the Cleveland Clinic Health System
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PSA TOOLProviders will be given the initial PSA TOOL and will be asked to give their feedback to revise the tool. | Behavioural | Provider Field Test |
| Revised PSA TOOLPatients will be given the revised PSA TOOL, after providers have given their initial feedback. | Behavioural | Patient test of revised PSA TOOL |
| Informal InterviewBoth patients and providers will have informal interviews with the study team to get feedback on the survey taking process. | Behavioural | Patient test of revised PSA TOOL, Provider Field Test |
Primary outcome
Score from Perceived Usefulness scale
Time frame: Up to 4 weeks after getting PSA TOOL
scale will be summarized as means and standard deviations
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2018.
Related trials for Prostate Cancer
RecruitingPhase 2
The COSMYC Trial (COmbined Suppression of MYC)
Metastatic Castration-resistant Prostate Cancer
Not yet recruitingPhase 3
A Study of JNJ-101556143 With Best Supportive Care in Participants With Metastatic Prostate Cancer
Prostatic Neoplasms
RecruitingPhase 1/2
Docetaxel and SX-682 in Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma, Salivary Gland Carcinoma, and Advanced Prostate Cancer
Head and Neck Cancer, Head and Neck Squamous Cell Carcinoma
RecruitingObservational study
PULSE Registry: for Patients Receiving Lutetium (177Lu) Vipivotide Tetraxetan
Metastatic Prostate Cancer
RecruitingPhase 2
Relugolix and Enzalutamide in Combination With Radiation Therapy for the Treatment of Very High Risk Prostate Cancer, OPTIMAL Trial
Prostate Adenocarcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anita Misra-Hebert, MD, MPH principal investigator
Cleveland Clinic, Case Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PSA TOOL, Revised PSA TOOL and Informal Interview in people with Prostate Cancer, run by Case Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 May 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Score from Perceived Usefulness scale (time frame: Up to 4 weeks after getting PSA TOOL). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2018.