Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer
NCT ID: NCT02093039
Last Updated: 2014-03-20
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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COMPLETED
NA
16000 participants
INTERVENTIONAL
2009-05-31
2010-06-30
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
PREVENTION
NONE
Study Groups
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Decision aid group
Women allocated to the decision aid group received an invitation to participate in the national breast cancer screening program and the specially-designed decision aid (a leaflet), by mail.
decision aid group
The paper-based leaflet DECIDEO is a 12-page pocket leaflet providing scientific information about the advantages and disadvantages of participating in the national breast screening program, understandable by all, constructed to conform with the International Patient Decision Aid Standards
Control group
Women in the control group received an invitation and the usual standard information by mail.
No interventions assigned to this group
Interventions
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decision aid group
The paper-based leaflet DECIDEO is a 12-page pocket leaflet providing scientific information about the advantages and disadvantages of participating in the national breast screening program, understandable by all, constructed to conform with the International Patient Decision Aid Standards
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
50 Years
74 Years
FEMALE
Yes
Sponsors
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Institut de Cancérologie de la Loire
OTHER
Responsible Party
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Principal Investigators
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Franck CHAUVIN, MDPhD
Role: PRINCIPAL_INVESTIGATOR
Institut de Cancérologie Lucien Neuwirth
Locations
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Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Countries
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References
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Bray F, Ren JS, Masuyer E, Ferlay J. Global estimates of cancer prevalence for 27 sites in the adult population in 2008. Int J Cancer. 2013 Mar 1;132(5):1133-45. doi: 10.1002/ijc.27711. Epub 2012 Jul 26.
Olsson S, Andersson I, Karlberg I, Bjurstam N, Frodis E, Hakansson S. Implementation of service screening with mammography in Sweden: from pilot study to nationwide programme. J Med Screen. 2000;7(1):14-8. doi: 10.1136/jms.7.1.14.
Walter LC, Lewis CL. Maximizing informed cancer screening decisions. Arch Intern Med. 2007 Oct 22;167(19):2027-8. doi: 10.1001/archinte.167.19.2027. No abstract available.
Raffle AE. Informed participation in screening is essential. BMJ. 1997 Jun 14;314(7096):1762-3. doi: 10.1136/bmj.314.7096.1762a. No abstract available.
Barratt A, Trevena L, Davey HM, McCaffery K. Use of decision aids to support informed choices about screening. BMJ. 2004 Aug 28;329(7464):507-10. doi: 10.1136/bmj.329.7464.507.
Elwyn G, O'Connor A, Stacey D, Volk R, Edwards A, Coulter A, Thomson R, Barratt A, Barry M, Bernstein S, Butow P, Clarke A, Entwistle V, Feldman-Stewart D, Holmes-Rovner M, Llewellyn-Thomas H, Moumjid N, Mulley A, Ruland C, Sepucha K, Sykes A, Whelan T; International Patient Decision Aids Standards (IPDAS) Collaboration. Developing a quality criteria framework for patient decision aids: online international Delphi consensus process. BMJ. 2006 Aug 26;333(7565):417. doi: 10.1136/bmj.38926.629329.AE. Epub 2006 Aug 14.
Mathieu E, Barratt A, Davey HM, McGeechan K, Howard K, Houssami N. Informed choice in mammography screening: a randomized trial of a decision aid for 70-year-old women. Arch Intern Med. 2007 Oct 22;167(19):2039-46. doi: 10.1001/archinte.167.19.2039.
Edwards A, Unigwe S, Elwyn G, Hood K. Effects of communicating individual risks in screening programmes: Cochrane systematic review. BMJ. 2003 Sep 27;327(7417):703-9. doi: 10.1136/bmj.327.7417.703.
Other Identifiers
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2008-01
Identifier Type: -
Identifier Source: org_study_id
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