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Trial record 7 of 2734 for:    prostate cancer AND Cancer | ( Map: United States )

Visually Enhanced Education About Prostate Cancer

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ClinicalTrials.gov Identifier: NCT02846870
Recruitment Status : Completed
First Posted : July 27, 2016
Last Update Posted : August 7, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Austin Kirschner, 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.

Condition or disease Intervention/treatment Phase
Stage I Prostate Cancer Stage II Prostate Cancer Stage III Prostate Cancer Other: Visually enhanced prostate cancer educational presentation Other: Standard prostate cancer education presentation Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
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 : September 2016
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

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




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Satisfaction - SCA [ Time Frame: baseline, end of treatment, and long-term follow-up ]
  2. Symptoms based on EPIC-26 short form [ Time Frame: baseline, end of treatment, and long-term follow-up ]
  3. Anxiety - Memorial MAX-PC scale [ Time Frame: 1 week ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02846870


Locations
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United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37203
Sponsors and Collaborators
Vanderbilt-Ingram Cancer Center
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Austin Kirschner, MD Vanderbilt University

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Responsible Party: Austin Kirschner, Principal Investigator, Vanderbilt-Ingram Cancer Center
ClinicalTrials.gov Identifier: NCT02846870     History of Changes
Other Study ID Numbers: VICC RAD 1646
NCI-2016-00777 ( Registry Identifier: Clinical Trials Reporting Program )
First Posted: July 27, 2016    Key Record Dates
Last Update Posted: August 7, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Additional relevant MeSH terms:
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Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases