Ignite Creation Date:
2024-05-05 @ 11:58 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00196807
Status:
COMPLETED
Last Update Posted:
2010-01-20
First Post:
2005-09-12
Brief Title:
Prostate Cancer Screening Fostering Informed Decisions
Sponsor:
Georgetown University
Organization:
Georgetown University
Study Overview
Official Title:
Prostate Cancer Screening Fostering Informed Decisions
Status:
COMPLETED
Status Verified Date:
2010-01
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 primary goal of this study is to develop and evaluate a print-based method of patient education with a decision tool that is designed to provide detailed information about prostate cancer and to clarify patient preferences and values ultimately assisting men in making an informed screening decision
Detailed Description:
In spite of the significant disease burden presented by PCa the utility of screening asymptomatic men remains controversial as it has not yet been demonstrated by a randomized trial that early diagnosis and treatment of PCa reduces disease-related mortality The primary goal of the proposed study is neither to encourage nor discourage PCa screening but to evaluate a method of patient education that is designed to provide detailed screening and treatment-related information and to clarify patient preferences and values ultimately assisting men in making an informed screening decision The target population for this educational intervention will be men who have registered to undergo PCa screening within a free mass screening program Although at first this may appear to be an atypical group to target for an educational intervention we present information suggesting that this population represents a large and uniformed group for whom effective and inexpensive methods of education are of critical importance We will test the impact of providing men with detailed information and a decision aid vs usual care information and the impact of the timing of administration of information a week or more prior to the screening vs usual care which is on the day of screening Participants will include men who register for the annual PCa mass screening programs held at Georgetown University and at Howard University during the 2004 and 2005 screening programs Following enrollment and the baseline interview participants will be randomly assigned to one of four groups 1 Information plus Decision Aid received prior to the scheduled screening date IDA-home 2 Information plus Decision Aid received on the day of screening IDA-clinic 3 Usual Care information received prior to the scheduled screening date UC-home or 4 Usual Care information received on the day of the screening UC-clinic Follow-up assessments will be conducted post-screening post receipt of screening results and one-year post-intervention to measure knowledge decisional conflict decisional satisfaction and the actual screening decision We will utilize a 2 IDAUC X 2 HomeClinic X 2 AAwhite repeated measures analysis of covariance to assess for group differences on these outcomes If found to be effective the long-term goal of this research program is to disseminate this informational decision aid for use in mass screening programs
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 |
|---|---|---|---|
| R01CA098967 | NIH | None | httpsreporternihgovquickSearchR01CA098967 |