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| Tracking Information | |||||
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| First Received Date ICMJE | March 14, 2001 | ||||
| Last Updated Date | August 6, 2009 | ||||
| Start Date ICMJE | |||||
| Primary Completion Date | |||||
| Current Primary Outcome Measures ICMJE | |||||
| Original Primary Outcome Measures ICMJE |
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| Change History | Complete list of historical versions of study NCT00013247 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | |||||
| Original Secondary Outcome Measures ICMJE | |||||
| Descriptive Information | |||||
| Brief Title ICMJE | Facilitating Shared Decisionmaking About Prostate Cancer Screening | ||||
| Official Title ICMJE | Facilitating Shared Decisionmaking About Prostate Cancer Screening | ||||
| Brief Summary | Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions. |
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| Detailed Description | Background: Due to the disputed efficacy of prostate cancer (CaP) screening and treatment, most authorities recommend that providers inform and involve patients in CaP screening decisions. Objectives: This study evaluated two interventions designed to facilitate this process. Methods: 1152 male veterans age 50+ with no CaP and primary care appointments at four VA medical facilities in VISN 23 were randomly assigned to one of three groups: mailed pamphlet intervention, mailed video intervention, or usual care (control). Intervention materials were mailed two weeks prior to a target primary care appointment and patient telephone surveys were conducted one week (T1) and one year (T2) after the target appointment. Outcomes included: a 10- item validated knowledge index; responses to questions on CaP natural history, treatment efficacy, PSA accuracy, and expert disagreement about the PSA; whether screening was discussed with provider; scores on decision information seeking, participation and satisfaction scales; screening and treatment preferences; and PSA testing rates. Status: Complete |
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| Study Phase | |||||
| Study Type ICMJE | Interventional | ||||
| Study Design ICMJE | Treatment, Randomized, Single Blind, Active Control, Single Group Assignment, Efficacy Study | ||||
| Condition ICMJE | Prostate Cancer | ||||
| Intervention ICMJE | Behavioral: Prostate Cancer Screening Education | ||||
| Study Arms / Comparison Groups | |||||
| Publications * |
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Estimated Enrollment ICMJE | 1152 | ||||
| Completion Date | December 2002 | ||||
| Primary Completion Date | |||||
| Eligibility Criteria ICMJE | Inclusion Criteria: Patients must be male veterans, age 50 and older, with a scheduled primary care appointment at one of 5 VISN 13 medical facilities. Patients diagnosed with prostate cancer will be excluded. Exclusion Criteria: |
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| Gender | Male | ||||
| Ages | 50 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT ID ICMJE | NCT00013247 | ||||
| Responsible Party | Partin, Melissa - Principal Investigator, Department of Veterans Affairs | ||||
| Study ID Numbers ICMJE | IIR 99-277 | ||||
| Study Sponsor ICMJE | Department of Veterans Affairs | ||||
| Collaborators ICMJE | |||||
| Investigators ICMJE |
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| Information Provided By | Department of Veterans Affairs | ||||
| Verification Date | June 2005 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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