Visually Enhanced Education About Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
This randomized clinical trial studies how well visually enhanced education works in improving prostate cancer and treatment knowledge in patients with prostate cancer that has not spread to other places in the body. Visually enhanced education includes pictures, drawings, and photos, may help doctors better convey information about radiation and prostate cancer to patients.

Detailed Description
-----------------
PRIMARY OBJECTIVES: I. Our goal is to conduct a randomized controlled trial to determine the impact of a visual presentation in the context of a radiation oncologist's discussion with patient during consultation on patient satisfaction at end of consultation visit and at end of treatment, on anxiety at start of treatment, on decision regret following treatment, and on perception of side effects following treatment. Of note, the attending radiation oncologist will be responsible for reviewing the Powerpoint presentation with the patient, taking time to answer any questions that the patient has OUTLINE: Patients are randomized into 1 of 2 arms. ARM A (STANDARD EDUCATION): Patients receive a standard prostate cancer radiation oncology consultation. ARM B (VISUAL ENHANCED EDUCATION): Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation.

Official Title
-----------------
Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial

Conditions
-----------------
Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

Intervention / Treatment
-----------------
* Other: Visually enhanced prostate cancer educational presentation
* Other: Standard prostate cancer education presentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient must have non-metastatic, biopsy proven prostate cancer Must be referred to radiation oncology clinic Exclusion Criteria: Prior surgery or radiation therapy for prostate cancer Patients who are blind are excluded

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Education<br>Patients receive standard-of-care prostate cancer radiation oncology consultation. | Other: Standard prostate cancer education presentation<br>* Receive standard prostate cancer education presentation<br>|
| Experimental: Visually Enhanced Education<br>Patients receive a visually enhanced prostate cancer educational Powerpoint presentation including prostate anatomy, pathologic results, surgical options, radiation therapy, and prognosis with pictographs during radiation oncology consultation. | Other: Visually enhanced prostate cancer educational presentation<br>* Receive visually enhanced prostate cancer educational presentation<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Decision-Regret - based on Ottawa scale | Sample size was determined based on this primary outcome - with estimated mean of 16 in Arm A and mean of 8 in Arm B, with standard deviation of 15, with 80% power and alpha of 0.05. | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction - SCA |  | baseline, end of treatment, and long-term follow-up | 
| Symptoms based on EPIC-26 short form |  | baseline, end of treatment, and long-term follow-up | 
| Anxiety - Memorial MAX-PC scale |  | 1 week |