Visually Enhanced Education About Prostate Cancer

Not Applicable

Completed

• Conditions: Stage I Prostate Cancer; Stage II Prostate Cancer; Stage III Prostate Cancer
• Interventions: Other: Visually enhanced prostate cancer educational presentation; Other: Standard prostate cancer education presentation

• Registration Number: NCT02846870
• Lead Sponsor: Vanderbilt-Ingram Cancer Center

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.

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 Timeline

• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-27
• Study Start: 2016-09
• Primary Completion: 2017-08
• Study Completion: 2018-08
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-21
• Last Update Posted: 2020-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 30

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Visually Enhanced Education	Visually enhanced prostate cancer educational 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.
Standard Education	Standard prostate cancer education presentation	Patients receive standard-of-care prostate cancer radiation oncology consultation.

Primary Outcome Measures

Name	Time	Method
Decision-Regret - based on Ottawa scale	Up to 12 weeks	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.

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States