Visually Enhanced Education About Prostate Cancer

Sponsor
Vanderbilt-Ingram Cancer Center (Other)
Overall Status
Completed
CT.gov ID
NCT02846870
Collaborator
National Cancer Institute (NCI) (NIH)
30
1
2
23
1.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Visually enhanced prostate cancer educational presentation
  • Other: Standard prostate cancer education presentation
N/A

Detailed Description

PRIMARY OBJECTIVES:
  1. 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 Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Visually Enhanced Education About Prostate Cancer (VEEP-C): A Randomized Controlled Trial
Study Start Date :
Sep 1, 2016
Actual Primary Completion Date :
Aug 1, 2017
Actual Study Completion Date :
Aug 1, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard Education

Patients receive standard-of-care prostate cancer radiation oncology consultation.

Other: Standard prostate cancer education presentation
Receive standard prostate cancer education presentation

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.

Other: Visually enhanced prostate cancer educational presentation
Receive visually enhanced prostate cancer educational presentation

Outcome Measures

Primary Outcome Measures

  1. 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

  1. Satisfaction - SCA [baseline, end of treatment, and long-term follow-up]

  2. Symptoms based on EPIC-26 short form [baseline, end of treatment, and long-term follow-up]

  3. Anxiety - Memorial MAX-PC scale [1 week]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Male
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Vanderbilt University Medical Center Nashville Tennessee United States 37203

Sponsors and Collaborators

  • Vanderbilt-Ingram Cancer Center
  • National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Austin Kirschner, MD, Vanderbilt University

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Austin Kirschner, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier:
NCT02846870
Other Study ID Numbers:
  • VICC RAD 1646
  • NCI-2016-00777
First Posted:
Jul 27, 2016
Last Update Posted:
Jul 23, 2020
Last Verified:
Jul 1, 2020
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jul 23, 2020