Internet-Based Education for Prostate Cancer Screening

Prostate Cancer Clinical Trial

— PCSEd  

Official title:

Internet-Based Education for Prostate Cancer Screening

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00623090
• Other study ID #: PC051100
• Secondary ID: R01CA119168-01
• Status: Completed
• Phase: Phase 3
• First received: February 14, 2008
• Last updated: December 11, 2012
• Start date: October 2007
• Est. completion date: August 2011

Study information

• Verified date: December 2012
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1893
• Est. completion date: August 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 45 Years to 70 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Screening

Related Conditions & MeSH terms

• Prostate Cancer
• Prostatic Neoplasms

Intervention

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.
• Educational print booklet
Healthy men between 45-70 receive a copy of our educational print booklet in the mail.
• 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.

Locations

Country	Name	City	State
United States	Georgetown University Medical Center	Washington	District of Columbia
United States	Washington Hospital Center	Washington	District of Columbia

Sponsors (3)

Lead Sponsor	Collaborator
Georgetown University	National Cancer Institute (NCI), United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	screening decision		one-year follow up	No
Primary	knowledge about prostate cancer screening		one-month and one-year post-intervention	No
Primary	decisional satisfaction		one-month and one-year post intervention	No