Internet-Based Education for Prostate Cancer Screening (PCSEd)

This study has been completed.
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Kathryn L. Taylor, Ph.D., Georgetown University
ClinicalTrials.gov Identifier:
NCT00623090
First received: February 14, 2008
Last updated: December 11, 2012
Last verified: December 2012
  Purpose

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 Intervention Phase
Prostate Cancer
Behavioral: educational internet site on prostate cancer screening
Behavioral: Educational print booklet
Behavioral: Usual care
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Screening
Official Title: Internet-Based Education for Prostate Cancer Screening

Resource links provided by NLM:


Further study details as provided by Georgetown University:

Primary Outcome Measures:
  • screening decision [ Time Frame: one-year follow up ] [ Designated as safety issue: No ]
  • knowledge about prostate cancer screening [ Time Frame: one-month and one-year post-intervention ] [ Designated as safety issue: No ]
  • decisional satisfaction [ Time Frame: one-month and one-year post intervention ] [ Designated as safety issue: No ]

Enrollment: 1893
Study Start Date: October 2007
Study Completion Date: August 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   45 Years to 70 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00623090

Locations
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
Investigators
Principal Investigator: Kathryn L. Taylor, PhD Georgetown University
  More Information

No publications provided by Georgetown University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Kathryn L. Taylor, Ph.D., Associate Professor, Georgetown University
ClinicalTrials.gov Identifier: NCT00623090     History of Changes
Other Study ID Numbers: PC051100, R01CA119168-01
Study First Received: February 14, 2008
Last Updated: December 11, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Georgetown University:
prostate cancer screening education
behavioral oncology
randomized trial

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

ClinicalTrials.gov processed this record on September 18, 2014