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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02846870
Other study ID # VICC RAD 1646
Secondary ID NCI-2016-00777
Status Completed
Phase N/A
First received
Last updated
Start date September 2016
Est. completion date August 2018

Study information

Verified date July 2020
Source Vanderbilt-Ingram Cancer Center
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date August 2018
Est. primary completion date August 2017
Accepts healthy volunteers No
Gender Male
Age group 18 Years and older
Eligibility 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 Design


Intervention

Other:
Visually enhanced prostate cancer educational presentation
Receive visually enhanced prostate cancer educational presentation
Standard prostate cancer education presentation
Receive standard prostate cancer education presentation

Locations

Country Name City State
United States Vanderbilt University Medical Center Nashville Tennessee

Sponsors (2)

Lead Sponsor Collaborator
Vanderbilt-Ingram Cancer Center National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Satisfaction - SCA baseline, end of treatment, and long-term follow-up
Secondary Symptoms based on EPIC-26 short form baseline, end of treatment, and long-term follow-up
Secondary Anxiety - Memorial MAX-PC scale 1 week
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