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CompletedNCT00164437Updated Sep 14, 2005

CD-ROM Intervention for Prostate Cancer Screening

A Phase 2/3 interventional study of educational CD-ROM in Prostate Cancer, sponsored by Centers for Disease Control and Prevention. Completed at 1 site in United States. Open to male participants aged 45 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2005-09-14.

Sponsored by Centers for Disease Control and Prevention · Phase 2/3, Interventional, and Educational/counseling/training

Phase
Phase 2/3
Study type
Interventional
Enrollment
554
Allocation
Randomized
Ages
45 Years and older
Sex
Male
01

Study 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.

Read the 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.

02

Conditions studied

  • Prostate Cancer

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Keywords

  • screening
  • community healt education
  • decision making
  • computer-assisted decision making
03

In context

Prostatic Neoplasms

6,370 studies on the registry are indexed under Prostatic Neoplasms; 1,400 are open to participants now.

This study's enrollment of 554 is above the median of 58 across 4,822 interventional studies indexed under Prostatic Neoplasms.

Browse Prostatic Neoplasms studies →

Lead sponsor

Centers for Disease Control and Prevention is the lead sponsor of 273 studies on the registry; 2 are open to participants now.

Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
45 Years and older
Sexes eligible
Male
Accepts healthy volunteers
Yes

Eligibility criteria

Inclusion Criteria:

-

Exclusion Criteria:

  • prostate cancer
05

Study design

Phase
Phase 2 / Phase 3
Primary purpose
Educational/counseling/training
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
554 participants

Interventions

  • Behavioraleducational CD-ROM
06

What researchers measure

Primary outcomes

  1. prostate cancer knowledge,

  2. ability to make an informed decision about prostate cancer screning,

  3. decisional conflict,

  4. realistic expectations

Secondary outcomes

  1. costs

07

Study locations

1 site
  • University of Colorado Health Sciences Center
    Denver, Colorado 80262, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 14, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00164437
Lead sponsor
Centers for Disease Control and Prevention
Collaborators
University of Colorado, Denver
First posted
Sep 14, 2005
Start date
Sep 2002
Completion
Sep 2004
Last update
Sep 14, 2005

Study contacts

Lori A. Crane, PhD, MPH
principal investigator · University of Colorado, Denver
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2005. You cannot join it, but the record below documents what was studied.

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