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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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5 November 2012 |
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Main ID: |
NCT00432601 |
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Date of registration:
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06/02/2007 |
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Primary sponsor: |
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Public title:
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Testing the Helpfulness of 2 Decision Aids for Prostate Cancer
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Scientific title:
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Impact of a Plain Language Prostate Cancer Decision Aid on Decision Making |
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Date of first enrolment:
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August 2008 |
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Target sample size:
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500 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00432601 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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Angela Fagerlin, PhD MA |
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Address:
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Telephone:
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Email:
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Affiliation:
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VA Ann Arbor Healthcare System |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
Must be undergoing a prostate cancer biopsy at Ann Arbor, Durham, San Francisco, or
Pittsburgh VAs
Exclusion Criteria:
Prior history of prostate cancer
Age minimum:
N/A
Age maximum:
N/A
Gender:
Male
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Health Condition(s) or Problem(s) studied
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Prostate Cancer
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Intervention(s)
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Behavioral: type of decision aid
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Primary Outcome(s)
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knowledge, risk perception, decision making, patient-physician communication
[Time Frame: Prebiopsy or biopsy appointment (Time 1); Results visit (Time 2); 7-10 Days After Results visit (Time 3)]
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Secondary Outcome(s)
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satisfaction with decision aid, anxiety
[Time Frame: Anxiety: Prebiopsy appointment (Time 1); Results visit (Time 2); 7-10 Days After Diagnosis visit (Time 3). Satisfaction: 7-10 Days After Results visit (Time 3)]
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Secondary ID(s)
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IIR 05-283
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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