Internet-Based Education for Prostate Cancer Screening

NCT ID: NCT00623090

Last Updated: 2012-12-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1893 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-10-31
• Study Completion Date: 2011-08-31

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.

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.

Conditions

Prostate Cancer

Keywords

prostate cancer screening education; behavioral oncology; randomized trial

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

1 Website

Participants receive the Login information for the Internet we developed on prostate cancer screening.

Group Type: EXPERIMENTAL

educational internet site on prostate cancer screening

Intervention Type: BEHAVIORAL

Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.

2 Booklet

Participants receive the education booklet we developed on prostate cancer screening.

Group Type: ACTIVE_COMPARATOR

Educational print booklet

Intervention Type: BEHAVIORAL

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

3 Usual Care

Usual care: participants receive no intervention.

Group Type: PLACEBO_COMPARATOR

Usual care

Intervention Type: BEHAVIORAL

Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.

Interventions

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.

Intervention Type: BEHAVIORAL

Educational print booklet

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

Intervention Type: 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.

Intervention Type: BEHAVIORAL

Eligibility 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.

• Minimum Eligible Age: 45 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Georgetown University

OTHER

Sponsor Role: lead

Responsible Party

Kathryn L. Taylor, Ph.D.

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn L. Taylor, PhD

Role: PRINCIPAL_INVESTIGATOR

Georgetown University

Locations

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Washington Hospital Center

Washington D.C., District of Columbia, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 20199680 (View on PubMed)

Other Identifiers

R01CA119168-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

PC051100

Identifier Type: -

Identifier Source: org_study_id