search
Back to results

CD-ROM Intervention for Prostate Cancer Screening

Primary Purpose

Prostate Cancer

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
educational CD-ROM
Sponsored by
Centers for Disease Control and Prevention
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional educational/counseling/training trial for Prostate Cancer focused on measuring screening, community healt education, decision making, computer-assisted decision making

Eligibility Criteria

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

Inclusion Criteria: - Exclusion Criteria: prostate cancer

Sites / Locations

  • University of Colorado Health Sciences Center

Outcomes

Primary Outcome Measures

prostate cancer knowledge,
ability to make an informed decision about prostate cancer screning,
decisional conflict,
realistic expectations

Secondary Outcome Measures

costs

Full Information

First Posted
September 12, 2005
Last Updated
September 12, 2005
Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Colorado, Denver
search

1. Study Identification

Unique Protocol Identification Number
NCT00164437
Brief Title
CD-ROM Intervention for Prostate Cancer Screening
Official Title
CD-ROM Intervention for Prostate Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
September 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
September 2004 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Centers for Disease Control and Prevention
Collaborators
University of Colorado, Denver

4. Oversight

5. Study Description

Brief Summary
The study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the CD-Rom educational intervention.
Detailed Description
The study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the CD-Rom educational intervention. Preliminary results are available for the first 1304 follow-up interviews (interim response rate = 26%). Of 554 men randomized to receive the CD-ROM, 227 (41%) reported receiving the CD-ROM, and 78 (14%) used it in a computer. About 51% of these 78 men used the CD-ROM once only, while 42% used it twice, and 27% shared it with someone else. Most users reported learning some (44%) or a great deal (46%) of new information from the CD-ROM, and most reported that it helped them organize their thoughts about screening somewhat (44%) or a great deal (28%). About 19% indicated that the CD-ROM increased their uncertainty somewhat or a great deal about whether or not they want to be screened, 30% reported that the CD-ROM changed their feelings about whether or not they want to be screened somewhat, and 12% reported that it changed their feelings a great deal. Men who used the CD-ROM had higher education, higher income, higher levels of computer usage, and were more likely to have previously had a PSA test compared to non-users. No other subject characteristics were significantly related to use. Using randomized group assignment in an "intention to treat" analysis, prostate cancer knowledge was significantly higher in the intervention group; there were no differences between study groups in decisional conflict or realistic expectations. However, when comparing those who did and did not use the CD-ROM using multiple regression analysis and controlling for differences in age, race, education, income, insurance status, previous receipt of prostate cancer screening, and computer usage, use of the CD-ROM was significantly associated with higher prostate cancer related knowledge, lower decisional conflict, and more realistic expectations about risk of dying from prostate cancer. After controlling for differences between users and non-users we found evidence that the CD-ROM was effective in reducing decisional conflict, and increasing knowledge and realistic expectations related to prostate cancer screening.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer
Keywords
screening, community healt education, decision making, computer-assisted decision making

7. Study Design

Primary Purpose
Educational/Counseling/Training
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
554 (false)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
educational CD-ROM
Primary Outcome Measure Information:
Title
prostate cancer knowledge,
Title
ability to make an informed decision about prostate cancer screning,
Title
decisional conflict,
Title
realistic expectations
Secondary Outcome Measure Information:
Title
costs

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: - Exclusion Criteria: prostate cancer
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lori A. Crane, PhD, MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Colorado Health Sciences Center
City
Denver
State/Province
Colorado
ZIP/Postal Code
80262
Country
United States

12. IPD Sharing Statement

Learn more about this trial

CD-ROM Intervention for Prostate Cancer Screening

We'll reach out to this number within 24 hrs