search
Back to results

Internet-Based Education for Prostate Cancer Screening (PCSEd)

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
educational internet site on prostate cancer screening
Educational print booklet
Usual care
Sponsored by
Georgetown University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Prostate Cancer focused on measuring prostate cancer screening education, behavioral oncology, randomized trial

Eligibility Criteria

45 Years - 70 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Georgetown University Medical Center
  • Washington Hospital Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

1 Website

2 Booklet

3 Usual Care

Arm Description

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

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

Usual care: participants receive no intervention.

Outcomes

Primary Outcome Measures

screening decision
knowledge about prostate cancer screening
decisional satisfaction

Secondary Outcome Measures

Full Information

First Posted
February 14, 2008
Last Updated
December 11, 2012
Sponsor
Georgetown University
Collaborators
United States Department of Defense, National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00623090
Brief Title
Internet-Based Education for Prostate Cancer Screening
Acronym
PCSEd
Official Title
Internet-Based Education for Prostate Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
October 2007 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Georgetown University
Collaborators
United States Department of Defense, National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
prostate cancer screening education, behavioral oncology, randomized trial

7. Study Design

Primary Purpose
Screening
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1893 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1 Website
Arm Type
Experimental
Arm Description
Participants receive the Login information for the Internet we developed on prostate cancer screening.
Arm Title
2 Booklet
Arm Type
Active Comparator
Arm Description
Participants receive the education booklet we developed on prostate cancer screening.
Arm Title
3 Usual Care
Arm Type
Placebo Comparator
Arm Description
Usual care: participants receive no intervention.
Intervention Type
Behavioral
Intervention Name(s)
educational internet site on prostate cancer screening
Intervention Description
Healthy men between 45-70 receive the login information to access our educational internet site on prostate cancer screening.
Intervention Type
Behavioral
Intervention Name(s)
Educational print booklet
Intervention Description
Healthy men between 45-70 receive a copy of our educational print booklet in the mail.
Intervention Type
Behavioral
Intervention Name(s)
Usual care
Intervention Description
Healthy men aged 45-70 receive no intervention and are followed for one year, along with the men in the two intervention arms.
Primary Outcome Measure Information:
Title
screening decision
Time Frame
one-year follow up
Title
knowledge about prostate cancer screening
Time Frame
one-month and one-year post-intervention
Title
decisional satisfaction
Time Frame
one-month and one-year post intervention

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathryn L. Taylor, PhD
Organizational Affiliation
Georgetown University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
Washington Hospital Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
20199680
Citation
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.
Results Reference
derived

Learn more about this trial

Internet-Based Education for Prostate Cancer Screening

We'll reach out to this number within 24 hrs