Internet-Based Education for Prostate Cancer Screening
PCSEd
2 other identifiers
interventional
1,893
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3 prostate-cancer
Started Oct 2007
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2007
CompletedFirst Submitted
Initial submission to the registry
February 14, 2008
CompletedFirst Posted
Study publicly available on registry
February 25, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2011
CompletedDecember 13, 2012
December 1, 2012
3.4 years
February 14, 2008
December 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (3)
screening decision
one-year follow up
knowledge about prostate cancer screening
one-month and one-year post-intervention
decisional satisfaction
one-month and one-year post intervention
Study Arms (3)
1 Website
EXPERIMENTALParticipants receive the Login information for the Internet we developed on prostate cancer screening.
2 Booklet
ACTIVE COMPARATORParticipants receive the education booklet we developed on prostate cancer screening.
3 Usual Care
PLACEBO COMPARATORUsual care: participants receive no intervention.
Interventions
Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.
Healthy men between 45-70 receive a copy of our educational print booklet in the mail.
Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.
Eligibility Criteria
You may qualify if:
- 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
- years of age; AND
- Ability to provide meaningful consent.
You may not qualify if:
- History of prostate cancer.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- United States Department of Defensecollaborator
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Washington Hospital Center
Washington D.C., District of Columbia, 20010, United States
Related Publications (1)
Dorfman CS, Williams RM, Kassan EC, Red SN, Dawson DL, Tuong W, Parker ER, Ohene-Frempong J, Davis KM, Krist AH, Woolf SH, Schwartz MD, Fishman MB, Cole C, Taylor KL. The development of a web- and a print-based decision aid for prostate cancer screening. BMC Med Inform Decis Mak. 2010 Mar 3;10:12. doi: 10.1186/1472-6947-10-12.
PMID: 20199680DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn L. Taylor, PhD
Georgetown University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 14, 2008
First Posted
February 25, 2008
Study Start
October 1, 2007
Primary Completion
March 1, 2011
Study Completion
August 1, 2011
Last Updated
December 13, 2012
Record last verified: 2012-12