CD-ROM Intervention for Prostate Cancer Screening

This study has been completed.
Sponsor:
Collaborator:
University of Colorado, Denver
Information provided by:
Centers for Disease Control and Prevention
ClinicalTrials.gov Identifier:
NCT00164437
First received: September 12, 2005
Last updated: NA
Last verified: September 2005
History: No changes posted

September 12, 2005
September 12, 2005
September 2002
Not Provided
  • prostate cancer knowledge,
  • ability to make an informed decision about prostate cancer screning,
  • decisional conflict,
  • realistic expectations
Same as current
No Changes Posted
costs
Same as current
Not Provided
Not Provided
 
CD-ROM Intervention for Prostate Cancer Screening
CD-ROM Intervention for Prostate Cancer Screening

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.

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.

Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Educational/Counseling/Training
Prostate Cancer
Behavioral: educational CD-ROM
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
554
September 2004
Not Provided

Inclusion Criteria:

-

Exclusion Criteria:

  • prostate cancer
Male
45 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00164437
CDC-NCCDPHP-4020, U48/CCU815787
Not Provided
Not Provided
Centers for Disease Control and Prevention
University of Colorado, Denver
Principal Investigator: Lori A. Crane, PhD, MPH University of Colorado, Denver
Centers for Disease Control and Prevention
September 2005

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP