Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00164437
Status:
COMPLETED
Last Update Posted:
2005-09-14
First Post:
2005-09-12
Brief Title:
CD-ROM Intervention for Prostate Cancer Screening
Sponsor:
Centers for Disease Control and Prevention
Organization:
Centers for Disease Control and Prevention
Study Overview
Official Title:
CD-ROM Intervention for Prostate Cancer Screening
Status:
COMPLETED
Status Verified Date:
2005-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mens 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 mens 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U48CCU815787 | None | None | None |