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Clinical Trials/NCT00164437
NCT00164437
Completed
Phase 2

CD-ROM Intervention for Prostate Cancer Screening

Centers for Disease Control and Prevention1 site in 1 country554 target enrollmentSeptember 2002
ConditionsProstate Cancer

Overview

Phase
Phase 2
Intervention
Not specified
Conditions
Prostate Cancer
Sponsor
Centers for Disease Control and Prevention
Enrollment
554
Locations
1
Primary Endpoint
decisional conflict,
Status
Completed
Last Updated
20 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
September 2002
End Date
September 2004
Last Updated
20 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Male

Investigators

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • prostate cancer

Outcomes

Primary Outcomes

decisional conflict,

prostate cancer knowledge,

realistic expectations

ability to make an informed decision about prostate cancer screning,

Secondary Outcomes

  • costs

Study Sites (1)

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