Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening

Study Overview
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Brief Summary
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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.

Detailed Description
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To conduct a feasibility study on implementing the computer-based screening decision aid for prostate cancer screening in a primary care setting during a 60-minute interview. To aid in informed decision making, the screening decision aid will include a graphical representation of predicted probabilities of prostate cancer diagnosis, prostate cancer-specific mortality, death from competing causes based on a man's unique demographic information. The study team will provide standardized counseling followed by individualized counseling with the screening decision aid. It will assess the quality of the decision making process (patient feels knowledgeable, informed of the risks/benefits, feels clear about their values, is involved in the decision), and quality of the decision.

Official Title
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Using Decision Analysis to Enhance Decision-Making Regarding Prostate Cancer Screening

Conditions
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Prostate Cancer

Intervention / Treatment
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* Behavioral: Prostate cancer decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Life expectancy > 10 years Ability to read English Exclusion Criteria: Personal history of prostate cancer Personal history of prostate biopsy or prostate surgery Prior prostate specific antigen screening in the past year leading up to their scheduled clinic visit Cognitive impairment

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostate Cancer Decision Aid<br>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<br>* 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<br>* Other names: screening decision aid;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of initial interviews completed in 60 minutes | 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. | 60 minutes from beginning of interview | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health Literacy | Five item scale measuring attitudes towards screening | 1 month after clinical visit | 
| Patient decisional control preferences | 4 item scale where lower scores indicate more positive outcomes from screening | 1 month after clinical visit | 
| Decisional conflict Scale | 16 item scale ranging in a score from 0-4 where higher scores indicate more disagreement | 1 month after clinical visit | 
| Multidimensional measure of informed choice | 10 item true/false scale | 1 month after clinical visit | 
| Decisional regret scale | 5 item questionnaire using 5 point Likert scales where higher scores indicate more disagreement | 1 month after clinical visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Decision Aid