Visually Enhanced Education About Prostate Cancer

Stage III Prostate Cancer Clinical Trial

Official title:

Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial

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
• 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
• 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

Related Conditions & MeSH terms

• Prostatic Neoplasms
• Stage I Prostate Cancer
• Stage II Prostate Cancer
• Stage III Prostate Cancer

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