Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening
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|ClinicalTrials.gov Identifier: NCT03387527|
Recruitment Status : Recruiting
First Posted : January 2, 2018
Last Update Posted : April 19, 2018
The purpose of this study is to evaluate a new counseling tool for patients deciding whether or not to undergo prostate cancer screening. This screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause. The researchers are evaluating whether or not patients find this screening decision aid helpful. As part of this study, participants will be asked for their response on questionnaires.
If patients find the screening decision aid helpful, the researchers will make it available at other clinic locations.
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer||Behavioral: Prostate cancer decision aid||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening|
|Actual Study Start Date :||February 1, 2018|
|Estimated Primary Completion Date :||January 2020|
|Estimated Study Completion Date :||January 2020|
Experimental: Prostate Cancer Decision Aid
The research intervention will be exposure to the screening decision aid. Patients will receive standardized counseling including population based risks and benefits of prostate cancer screening. Then, patients will be given opportunity to review the screening decision aid prior to offering a decision on whether or not to undergo prostate cancer screening. The patient decision aid will be a computer application that generates predicted risks associated with prostate cancer.
Behavioral: Prostate cancer decision aid
Patients will undergo standardized counseling and individualized counseling with the screening decision aid. The screening decision aid is a computer program that provides individual patients estimates of their risks of prostate cancer diagnosis, prostate cancer related death, or death from any cause
Other Name: screening decision aid
- Number of initial interviews completed in 60 minutes [ Time Frame: 60 minutes from beginning of interview ]To be considered feasible in a busy clinical setting, researchers anticipate 80% of the initial interviews to be completed within the allotted 60-minute interview time.
- Health Literacy [ Time Frame: 1 month after clinical visit ]Five item scale measuring attitudes towards screening
- Patient decisional control preferences [ Time Frame: 1 month after clinical visit ]4 item scale where lower scores indicate more positive outcomes from screening
- Decisional conflict Scale [ Time Frame: 1 month after clinical visit ]16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement
- Multidimensional measure of informed choice [ Time Frame: 1 month after clinical visit ]10 item true/false scale
- Decisional regret scale [ Time Frame: 1 month after clinical visit ]5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03387527
|Contact: Andrew Stephenson, MD||866-223-8100||CancerCenterResearch@ccf.org|
|United States, Ohio|
|Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center||Recruiting|
|Cleveland, Ohio, United States, 44195|
|Contact: Andew Stephenson, MD 216-445-1062|
|Principal Investigator:||Andrew Stephenson, MD||Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center|