An interventional study of Visually enhanced prostate cancer educational presentation and Standard prostate cancer education presentation in Stage I Prostate Cancer, Stage II Prostate Cancer and Stage III Prostate Cancer, sponsored by Vanderbilt-Ingram Cancer Center. Completed at 1 site in United States. Open to male participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-23.
Sponsored by Vanderbilt-Ingram Cancer Center · Not applicable, Interventional, and Supportive care
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.
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.
6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.
This study's enrollment of 30 is below the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.
Browse Prostatic Neoplasms studies →Vanderbilt-Ingram Cancer Center is the lead sponsor of 220 studies on the registry; 32 are open to participants now.
Of its 23 completed or terminated interventional studies of FDA-regulated products, 18 (78%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients receive standard-of-care prostate cancer radiation oncology consultation.
Other: Standard prostate cancer education presentation
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
Receive standard prostate cancer education presentation
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.
Time frame: Up to 12 weeks
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
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Plan to share: Undecided
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Vanderbilt-Ingram Cancer Center