Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsors and Collaborators: |
Georgetown University Department of Defense National Cancer Institute (NCI) |
---|---|
Information provided by: | Georgetown University |
ClinicalTrials.gov Identifier: | NCT00623090 |
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, easily disseminable 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.
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 two Washington DC area hospitals (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-disseminable 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.
Condition | Intervention | Phase |
---|---|---|
Prostate Cancer |
Behavioral: educational internet site on prostate cancer screening Behavioral: Educational print booklet Behavioral: Usual care |
Phase III |
Study Type: | Interventional |
Study Design: | Screening, Randomized, Open Label, Parallel Assignment |
Official Title: | Internet-Based Education for Prostate Cancer Screening |
Estimated Enrollment: | 1800 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | December 2010 |
Estimated Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
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.
|
2: Active Comparator
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.
|
3: No Intervention
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.
|
Ages Eligible for Study: | 45 Years to 70 Years |
Genders Eligible for Study: | Male |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn L. Taylor, PhD | 202-687=0649 | taylorkl@georgetown.edu |
United States, District of Columbia | |
Georgetown University Medical Center | Recruiting |
Washington, District of Columbia, United States, 20007 | |
Contact: Kathryn L Taylor, PhD 202-687-0649 taylorkl@georgetown.edu | |
Sub-Investigator: Mary B Fishman, MD | |
Washington Hospital Center | Recruiting |
Washington, District of Columbia, United States, 20010 | |
Contact: Kathryn L Taylor, PhD 202-687-0649 taylorkl@georgetown.edu | |
Principal Investigator: Carmella Cole, MD |
Principal Investigator: | Kathryn L. Taylor, PhD | Georgetown University |
Responsible Party: | Georgetown University, Lombardi Comprehensive Cancer Center ( Kathryn L. Taylor, PhD ) |
Study ID Numbers: | PC051100, R01 CA119168-01 |
Study First Received: | February 14, 2008 |
Last Updated: | February 22, 2008 |
ClinicalTrials.gov Identifier: | NCT00623090 |
Health Authority: | United States: Institutional Review Board |
prostate cancer screening education behavioral oncology randomized trial |
Prostatic Diseases Genital Neoplasms, Male Urogenital Neoplasms Genital Diseases, Male Prostatic Neoplasms |
Neoplasms Neoplasms by Site |