- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02846870
Visually Enhanced Education About Prostate Cancer
Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Tennessee
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Nashville, Tennessee, United States, 37203
- Vanderbilt University Medical Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Standard Education
Patients receive standard-of-care prostate cancer radiation oncology consultation.
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Receive standard prostate cancer education presentation
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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.
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Receive visually enhanced prostate cancer educational presentation
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Decision-Regret - based on Ottawa scale
Time Frame: Up to 12 weeks
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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.
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Up to 12 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Satisfaction - SCA
Time Frame: baseline, end of treatment, and long-term follow-up
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baseline, end of treatment, and long-term follow-up
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Symptoms based on EPIC-26 short form
Time Frame: baseline, end of treatment, and long-term follow-up
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baseline, end of treatment, and long-term follow-up
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Anxiety - Memorial MAX-PC scale
Time Frame: 1 week
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1 week
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Austin Kirschner, MD, Vanderbilt University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- VICC RAD 1646
- NCI-2016-00777 (Registry Identifier: Clinical Trials Reporting Program)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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