Comparison of Explicit, Implicit and no Values Clarification Decision Aids for Men Considering Prostate Cancer Screening
NCT ID: NCT03988673
Last Updated: 2019-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
276 participants
INTERVENTIONAL
2019-09-30
2020-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
QUADRUPLE
Study Groups
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decision aid with information only (control)
decision aid with information only, without values clarification method (VCM)
No interventions assigned to this group
decision aid with implicit VCM
decision aid with information plus an implicit VCM
Decision aid with implicit values clarification method (booklet or website)
The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a grid where statements about the subject will be presented (decision aid with implicit VCM).
decision aid with explicit VCM
decision aid with information plus an explicit VCM
Decision aid with explicit values clarification method (booklet or website)
The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a a grid where statements about the subject will be presented and men should indicate what statements they identify with (decision aid with explicit VCM).
Interventions
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Decision aid with implicit values clarification method (booklet or website)
The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a grid where statements about the subject will be presented (decision aid with implicit VCM).
Decision aid with explicit values clarification method (booklet or website)
The intervention will be an informative evidence-based material in the format of a booklet or website concerning prostate cancer screening. The values clarification method will be a a grid where statements about the subject will be presented and men should indicate what statements they identify with (decision aid with explicit VCM).
Eligibility Criteria
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Inclusion Criteria
* men with average risk for prostate cancer;
* willing and able to provide written informed consent.
Exclusion Criteria
50 Years
69 Years
MALE
Yes
Sponsors
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NOVA Medical School
OTHER
Georgetown University
OTHER
Universidade do Porto
OTHER
Responsible Party
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Principal Investigators
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Sofia Baptista, MD
Role: PRINCIPAL_INVESTIGATOR
Universidade do Porto
Central Contacts
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References
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Baptista S, Heleno B, Teixeira A, Taylor KL, Martins C. Comparison of explicit values clarification method (VCM), implicit VCM and no VCM decision aids for men considering prostate cancer screening: protocol of a randomized trial. BMC Med Inform Decis Mak. 2020 Apr 29;20(1):78. doi: 10.1186/s12911-020-1094-3.
Other Identifiers
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DA-VCM
Identifier Type: -
Identifier Source: org_study_id
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