Internet-Based Education for Prostate Cancer Screening (PCSEd)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00623090
Recruitment Status : Completed
First Posted : February 25, 2008
Last Update Posted : December 13, 2012
United States Department of Defense
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Kathryn L. Taylor, Ph.D., Georgetown University

Brief Summary:
Prostate cancer (PCa) is the leading cancer diagnosis among men and the second leading cause of male cancer death. However, screening asymptomatic men remains controversial, as early diagnosis and treatment of PCa has not yet demonstrated reduced disease-related mortality in a randomized trial. The goal of the current study is to develop and assess widely accessible methods to assist men in making informed decisions about PCa screening. We will compare the efficacy of a new web-based, interactive decision support approach to our existing print-based PCa screening decision tool, among a diverse sample of male primary care patients. Abundant evidence documents the expanding role of the Internet in increasing access to and understanding of health information and the need for systematic evaluations of Internet-based interventions. A novel aspect of the proposed trial will be our focus on cognitive biases as a factor that has limited the success of previous information-based interventions. Specifically, we will evaluate: 1) confirmation bias and 2) short-term consequences bias.

Condition or disease Intervention/treatment Phase
Prostate Cancer Behavioral: educational internet site on prostate cancer screening Behavioral: Educational print booklet Behavioral: Usual care Phase 3

Detailed Description:
In Phase I (months 1-8) of this five-year project, we will develop an interactive, Internet-based, patient information and decision aid. In Phase II (months 9-60), we will evaluate the impact of this decision aid in a randomized controlled trial with male primary care patients aged 45-70 from three Washington, District of Columbia area health care settings (N = 1875). Trial arms include: 1) print-based information and decision aid (Print), 2) web-based information plus interactive decision aid (Web), and 3) usual care (UC). Subjects will complete outcome assessments at baseline, one- and 13-months post-baseline. The specific aims are to: 1. Evaluate the impact of the delivery method (Web vs. Print vs. Usual Care) on the key patient outcome variables of knowledge, decisional satisfaction, and the screening decision. 2. Identify factors that moderate the interventions' impact on the primary outcomes. 3. Identify the mechanisms by which the interventions impact knowledge and decisional satisfaction. In exploratory analyses, we will evaluate factors that are related to use of the web and print materials. This research has the potential to make several significant and innovative contributions: 1) the development and evaluation of a widely accessible method of educating a heterogeneous group of patients about a controversial topic, which can be adapted for other similarly contentious issues, 2) a determination of whether Web based materials are a feasible method of patient education for this age cohort, compared to print materials, 3) an understanding of cognitive factors that may hinder comprehension of a controversial medical decision, 4) a determination of who among the target population benefits the most from a web-based intervention, and 5) the information required to streamline and target future web-based educational interventions.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1893 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: Internet-Based Education for Prostate Cancer Screening
Study Start Date : October 2007
Actual Primary Completion Date : March 2011
Actual Study Completion Date : August 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prostate Cancer

Arm Intervention/treatment
Experimental: 1 Website
Participants receive the Login information for the Internet we developed on prostate cancer screening.
Behavioral: educational internet site on prostate cancer screening
Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.

Active Comparator: 2 Booklet
Participants receive the education booklet we developed on prostate cancer screening.
Behavioral: Educational print booklet
Healthy men between 45-70 receive a copy of our educational print booklet in the mail.

Placebo Comparator: 3 Usual Care
Usual care: participants receive no intervention.
Behavioral: Usual care
Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.

Primary Outcome Measures :
  1. screening decision [ Time Frame: one-year follow up ]
  2. knowledge about prostate cancer screening [ Time Frame: one-month and one-year post-intervention ]
  3. decisional satisfaction [ Time Frame: one-month and one-year post intervention ]

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Active primary care patients at Georgetown University Medical Center, Washington Hospital Center, or Medstar Physician Partners (I,e, seen during the past two years)
  • English-speaking
  • 45-70 years of age; AND
  • Ability to provide meaningful consent.

Exclusion Criteria:

  • History of prostate cancer.

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 identifier (NCT number): NCT00623090

United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
Washington Hospital Center
Washington, District of Columbia, United States, 20010
Sponsors and Collaborators
Georgetown University
United States Department of Defense
National Cancer Institute (NCI)
Principal Investigator: Kathryn L. Taylor, PhD Georgetown University

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Kathryn L. Taylor, Ph.D., Associate Professor, Georgetown University Identifier: NCT00623090     History of Changes
Other Study ID Numbers: PC051100
R01CA119168-01 ( U.S. NIH Grant/Contract )
First Posted: February 25, 2008    Key Record Dates
Last Update Posted: December 13, 2012
Last Verified: December 2012

Keywords provided by Kathryn L. Taylor, Ph.D., Georgetown University:
prostate cancer screening education
behavioral oncology
randomized trial

Additional relevant MeSH terms:
Prostatic Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Genital Diseases, Male
Prostatic Diseases