Visually Enhanced Education About Prostate Cancer

Overview

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.

Full Title of Study: “Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: None (Open Label)
  • Study Primary Completion Date: August 2017

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.

Interventions

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

Arms, Groups and Cohorts

  • Active Comparator: Standard Education
    • Patients receive standard-of-care prostate cancer radiation oncology consultation.
  • Experimental: Visually 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.

Clinical Trial Outcome Measures

Primary Measures

  • Decision-Regret – based on Ottawa scale
    • Time Frame: 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 Measures

  • 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

Participating in This Clinical Trial

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

Gender Eligibility: Male

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Vanderbilt-Ingram Cancer Center
  • Collaborator
    • National Cancer Institute (NCI)
  • Provider of Information About this Clinical Study
    • Principal Investigator: Austin Kirschner, Principal Investigator – Vanderbilt-Ingram Cancer Center
  • Overall Official(s)
    • Austin Kirschner, MD, Principal Investigator, Vanderbilt University

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