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NCT Number: NCT02846870

Visually Enhanced Education About Prostate Cancer

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.

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Key information

Conditions

Stage I Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Stage II Prostate Cancer Stage III Prostate Cancer Urogenital Diseases Urogenital Neoplasms

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Visually enhanced prostate cancer educational presentation

Other

Receive visually enhanced prostate cancer educational presentation

Standard prostate cancer education presentation

Other

Receive standard prostate cancer education presentation

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Vanderbilt-Ingram Cancer Center

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2018
First posted
Jul 27, 2016
Registry last updated
Jul 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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