Prostate Cancer Screening: Fostering Informed Decisions
1 other identifier
interventional
543
1 country
2
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 prostate-cancer
Started Aug 2004
Shorter than P25 for phase_3 prostate-cancer
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 12, 2005
CompletedFirst Posted
Study publicly available on registry
September 20, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2006
CompletedStudy Completion
Last participant's last visit for all outcomes
November 1, 2006
CompletedJanuary 20, 2010
January 1, 2010
2.3 years
September 12, 2005
January 19, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient knowledge and decisional satisfaction measured at one month following the intervention.
one-month and one-year follow-up assesments
Secondary Outcomes (1)
Decisional conflict measured at one month and the screening decision measured at one year post intervention.
one-month and one-year follow-up assesments
Study Arms (4)
Information plus DA at home
EXPERIMENTALUC Information at home
ACTIVE COMPARATORInformation plus decision aid at clinic
EXPERIMENTALUC Information at clinic
ACTIVE COMPARATORInterventions
To evaluate the impact of the decision aid intervention (information plus decision aid (IDA) vs. usual care (UC)), and timing of intervention delivery (at Home (pre-screening) vs. in the Clinic (screening day)) on key patient outcome variables of PCa knowledge and decisional satisfaction.
Eligibility Criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Georgetown Universitylead
- National Cancer Institute (NCI)collaborator
Study Sites (2)
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007, United States
Howard University Hospital
Washington D.C., District of Columbia, 20060, United States
Related Publications (3)
Taylor KL, Africano NL, Schwartz M, Cullen J, Ahaghotu C. Prostate cancer screening at National Cancer Institute comprehensive and clinical cancer centers. J Natl Cancer Inst. 2004 Mar 3;96(5):414-5. doi: 10.1093/jnci/djh073. No abstract available.
PMID: 14996868BACKGROUNDRed SN, Kassan EC, Williams RM, Penek S, Lynch J, Ahaghotu C, Taylor KL. Underuse of colorectal cancer screening among men screened for prostate cancer: a teachable moment? Cancer. 2010 Oct 15;116(20):4703-10. doi: 10.1002/cncr.25229.
PMID: 20578178RESULTTaylor KL, Williams RM, Davis K, Luta G, Penek S, Barry S, Kelly S, Tomko C, Schwartz M, Krist AH, Woolf SH, Fishman MB, Cole C, Miller E. Decision making in prostate cancer screening using decision aids vs usual care: a randomized clinical trial. JAMA Intern Med. 2013 Oct 14;173(18):1704-12. doi: 10.1001/jamainternmed.2013.9253.
PMID: 23896732DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kathryn L. Taylor, Ph.D.
Georgetown University
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- FACTORIAL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
September 12, 2005
First Posted
September 20, 2005
Study Start
August 1, 2004
Primary Completion
November 1, 2006
Study Completion
November 1, 2006
Last Updated
January 20, 2010
Record last verified: 2010-01