Visually Enhanced Education About Prostate Cancer
2 other identifiers
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2016
CompletedFirst Posted
Study publicly available on registry
July 27, 2016
CompletedStudy Start
First participant enrolled
September 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2018
CompletedJuly 23, 2020
July 1, 2020
11 months
July 25, 2016
July 21, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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 Outcomes (3)
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
Study Arms (2)
Standard Education
ACTIVE COMPARATORPatients receive standard-of-care prostate cancer radiation oncology consultation.
Visually Enhanced Education
EXPERIMENTALPatients 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.
Interventions
Receive visually enhanced prostate cancer educational presentation
Receive standard prostate cancer education presentation
Eligibility Criteria
You may qualify if:
- Patient must have non-metastatic, biopsy proven prostate cancer
- Must be referred to radiation oncology clinic
You may not qualify if:
- Prior surgery or radiation therapy for prostate cancer
- Patients who are blind are excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vanderbilt-Ingram Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
Vanderbilt University Medical Center
Nashville, Tennessee, 37203, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Austin Kirschner, MD
Vanderbilt University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
July 25, 2016
First Posted
July 27, 2016
Study Start
September 1, 2016
Primary Completion
August 1, 2017
Study Completion
August 1, 2018
Last Updated
July 23, 2020
Record last verified: 2020-07