Testing Decision Aids About Early Stage Prostate Cancer

Study Overview
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Brief Summary
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This is an educational intervention study testing the effects of decision aids in promoting patient participation in early stage prostate cancer treatment decision making. The purpose of this study is to compare patient-physician communication between patients who receive a DVD that models patient communication strategies vs. those who do not receive a DVD. All patients will also receive a written decision aid that describes treatment options for early stage prostate cancer. The Investigators hypothesize that the DVD will: increase patients' perceptions of the importance of their preferences to their decision making increase patients' perceptions of their intention to discuss their values and preferences with their urologists and radiation oncologists increase patients' actual engagement with their physician during the clinical encounter increase the concordance between patient decision making preferences and actual decision making outcomes increase long term satisfaction with decision on type of treatment selected increase patient satisfaction with their decision and the decision making process influence patient perception of his physician (e.g., trust) and of the diagnosis visit

Official Title
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Promoting Shared Decision Making in Prostate Cancer Through Decision Aids

Conditions
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Prostatic Neoplasms

Intervention / Treatment
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* Behavioral: DVD Decision Aid
* Behavioral: Written decision aid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men aged 18 years and older Scheduled for a prostate biopsy to test for prostate cancer Ability to read and answer survey questions in English Exclusion Criteria: Previous diagnosis of prostate cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DVD Decision Aid<br>Eligible participants receive the written decision aid (Making the Choice: Deciding What to Do About Early Stage Prostate Cancer) AND the DVD decision aid (Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer), which provides instruction and recommendations on how to participate in shared decision making with one's physician. | Behavioral: DVD Decision Aid<br>* The decision aid, Discussing the Choice: Talking with your Doctor about Early Stage Prostate Cancer is a DVD modeling patient communication strategies. The DVD includes vignettes with actors depicting patient-physician discussions of prostate cancer treatments. In these vignettes, the patient models communication strategies designed to facilitate patient activation.<br>|
| Active Comparator: Written Decision Aid<br>Eligible participants receive the written decision aid (Making the Choice: Deciding What to Do About Early Stage Prostate Cancer) alone. | Behavioral: Written decision aid<br>* A written decision aid entitled Making the Choice: Deciding What to Do About Early Stage Prostate Cancer that describes treatment options for early stage prostate cancer.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-efficacy for discussing preferences (intention) | 14 item survey instrument | Time 1 (baseline) | 
| Self-efficacy for discussing preferences (intention) | 14 item survey instrument | Time 2 (post-intervention, an average of 3 days after Time 1 baseline) | 
| Self-efficacy for discussing preferences (actual) | 14 item survey instrument | Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference for shared decision making | 1 item survey instrument | Time 1 (baseline) | 
| Preference for shared decision making | 1 item survey instrument | Time 2 (post-intervention, an average of 3 days after Time 1 baseline) | 
| Prostate cancer related knowledge | 10 item survey instrument | Time 1 (baseline) | 
| Prostate cancer related knowledge | 10 item survey instrument | Time 2 (post-intervention, an average of 3 days after Time 1 baseline) | 
| Prostate cancer related knowledge | 12 item survey instrument | Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline) | 
| Prostate cancer related anxiety | 6 item survey instrument | Time 1 (baseline) | 
| Prostate cancer related anxiety | 6 item survey instrument | Time 2 (post-intervention, an average of 3 days after Time 1 baseline) | 
| Prostate cancer related anxiety | 6 item survey instrument | Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline) | 
| Prostate cancer related anxiety | 7 item survey instrument | Time 4 (6 months post diagnosis) | 
| Treatment preference | 1 item survey instrument | Time 2 (post-intervention, an average of 3 days after Time 1 baseline) | 
| Treatment decision | 2 item survey instrument | Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline) | 
| Treatment decision | 2 item survey instrument | Time 4 (6 months post diagnosis) | 
| Decisional regret | 5 item survey instrument | Time 4 (6 months post diagnosis) | 
| Preference for shared decision making | 1 item survey instrument | Time 3 (post-diagnosis, an average of 1 month after Time 1 baseline) | 
| Preference for shared decision making | 1 item survey instrument | Time 4 (6 months post diagnosis) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Health Communication, Physician-Patient Relationship, Decision Making, Patient-Physician communication, Decision Support Techniques