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Visually Enhanced Education About Prostate Cancer

Primary Purpose

Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Visually enhanced prostate cancer educational presentation

Standard prostate cancer education presentation

About this trial

This is an interventional supportive care trial for Stage I Prostate Cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)MaleDoes not accept healthy volunteers

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

Sites / Locations

Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard Education

Visually Enhanced Education

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Satisfaction - SCA

Symptoms based on EPIC-26 short form

Anxiety - Memorial MAX-PC scale

Full Information

NCT ID

NCT02846870

First Posted

July 25, 2016

Last Updated

July 21, 2020

Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT02846870

Brief Title

Visually Enhanced Education About Prostate Cancer

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

September 2016 (undefined)

Primary Completion Date

August 2017 (Actual)

Study Completion Date

August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Vanderbilt-Ingram Cancer Center

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

Yes

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Stage I Prostate Cancer, Stage II Prostate Cancer, Stage III Prostate Cancer

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

30 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Standard Education

Arm Type

Active Comparator

Arm Description

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

Arm Title

Visually Enhanced Education

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Visually enhanced prostate cancer educational presentation

Intervention Description

Receive visually enhanced prostate cancer educational presentation

Intervention Type

Other

Intervention Name(s)

Standard prostate cancer education presentation

Intervention Description

Receive standard prostate cancer education presentation

Primary Outcome Measure Information:

Title

Decision-Regret - based on Ottawa scale

Description

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.

Time Frame

Up to 12 weeks

Secondary Outcome Measure Information:

Title

Satisfaction - SCA

Time Frame

baseline, end of treatment, and long-term follow-up

Title

Symptoms based on EPIC-26 short form

Time Frame

baseline, end of treatment, and long-term follow-up

Title

Anxiety - Memorial MAX-PC scale

Time Frame

1 week

10. Eligibility

Sex

Male

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Austin Kirschner, MD

Organizational Affiliation

Vanderbilt University

Official's Role

Principal Investigator

Facility Information:

Facility Name

Vanderbilt University Medical Center

City

Nashville

State/Province

Tennessee

ZIP/Postal Code

37203

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

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Visually Enhanced Education About Prostate Cancer

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