Back to resultsInformed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer (DECIDEO)
Primary Purpose
Healthy, Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
decision aid group
Sponsored by
About this trial
This is an interventional prevention trial for Healthy focused on measuring breast cancer screening, patient decision aids, informed decision, empowerment, randomized control trial, From 50 to 74 years old, invited to national breast cancer screening
Eligibility Criteria
Inclusion Criteria:
- Women, aged between 50 and 74 years old living in 11 French departments
Exclusion Criteria:
-
Sites / Locations
- Institut de Cancérologie Lucien Neuwirth
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Decision aid group
Control group
Arm Description
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.
Women in the control group received an invitation and the usual standard information by mail.
Outcomes
Primary Outcome Measures
women's attendance rate for the breast cancer screening program during the 12 months following the invitation
Secondary Outcome Measures
the delay between the invitation and the date of attendance for breast cancer screening
Full Information
NCT ID
NCT02093039
First Posted
March 19, 2014
Last Updated
March 19, 2014
Sponsor
Institut de Cancérologie de la Loire
1. Study Identification
Unique Protocol Identification Number
NCT02093039
Brief Title
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer
Acronym
DECIDEO
Official Title
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2014
Overall Recruitment Status
Completed
Study Start Date
May 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institut de Cancérologie de la Loire
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The aim of this study is to assess the impact of a decision aid leaflet on the participation of women invited to participate in the French national breast cancer screening program.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Breast Cancer
Keywords
breast cancer screening, patient decision aids, informed decision, empowerment, randomized control trial, From 50 to 74 years old, invited to national breast cancer screening
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16000 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Decision aid group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control group
Arm Type
No Intervention
Arm Description
Women in the control group received an invitation and the usual standard information by mail.
Intervention Type
Device
Intervention Name(s)
decision aid group
Intervention Description
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
Primary Outcome Measure Information:
Title
women's attendance rate for the breast cancer screening program during the 12 months following the invitation
Time Frame
12 months
Secondary Outcome Measure Information:
Title
the delay between the invitation and the date of attendance for breast cancer screening
Time Frame
12 months
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
74 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Women, aged between 50 and 74 years old living in 11 French departments
Exclusion Criteria:
-
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franck CHAUVIN, MDPhD
Organizational Affiliation
Institut de Cancérologie Lucien Neuwirth
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie Lucien Neuwirth
City
Saint-Priest-en-Jarez
ZIP/Postal Code
42270
Country
France
12. IPD Sharing Statement
Citations:
PubMed Identifier
22752881
Citation
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.
Results Reference
background
PubMed Identifier
10807141
Citation
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.
Results Reference
background
PubMed Identifier
17954794
Citation
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.
Results Reference
background
PubMed Identifier
9202520
Citation
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.
Results Reference
background
PubMed Identifier
15331483
Citation
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.
Results Reference
background
PubMed Identifier
16908462
Citation
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.
Results Reference
background
PubMed Identifier
17954796
Citation
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.
Results Reference
background
PubMed Identifier
14512475
Citation
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.
Results Reference
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Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer
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