Visually Enhanced Education About Prostate Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02846870|
Recruitment Status : Active, not recruiting
First Posted : July 27, 2016
Last Update Posted : August 7, 2018
|Condition or disease||Intervention/treatment||Phase|
|Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer||Other: Visually enhanced prostate cancer educational presentation Other: Standard prostate cancer education presentation||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial|
|Study Start Date :||September 2016|
|Actual Primary Completion Date :||August 2017|
|Estimated Study Completion Date :||July 2019|
Active Comparator: Standard Education
Patients receive standard-of-care prostate cancer radiation oncology consultation.
Other: Standard prostate cancer education presentation
Receive standard prostate cancer education presentation
Experimental: Visually 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.
Other: Visually enhanced prostate cancer educational presentation
Receive visually enhanced prostate cancer educational presentation
- Decision-Regret - based on Ottawa scale [ Time Frame: Up to 12 weeks ]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.
- Satisfaction - SCA [ Time Frame: baseline, end of treatment, and long-term follow-up ]
- Symptoms based on EPIC-26 short form [ Time Frame: baseline, end of treatment, and long-term follow-up ]
- Anxiety - Memorial MAX-PC scale [ Time Frame: 1 week ]
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): NCT02846870
|United States, Tennessee|
|Vanderbilt University Medical Center|
|Nashville, Tennessee, United States, 37203|
|Principal Investigator:||Austin Kirschner, MD||Vanderbilt University|