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Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer (DECIDEO)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02093039
First Posted: March 20, 2014
Last Update Posted: March 20, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire
March 19, 2014
March 20, 2014
March 20, 2014
May 2009
June 2010   (Final data collection date for primary outcome measure)
women's attendance rate for the breast cancer screening program during the 12 months following the invitation [ Time Frame: 12 months ]
Same as current
No Changes Posted
the delay between the invitation and the date of attendance for breast cancer screening [ Time Frame: 12 months ]
Same as current
Not Provided
Not Provided
 
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer
Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis
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.
Not Provided
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
  • Healthy
  • Breast Cancer
Device: 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
  • Experimental: 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.
    Intervention: Device: decision aid group
  • No Intervention: Control group
    Women in the control group received an invitation and the usual standard information by mail.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16000
June 2010
June 2010   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Women, aged between 50 and 74 years old living in 11 French departments

Exclusion Criteria:

Sexes Eligible for Study: Female
50 Years to 74 Years   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
France
 
 
NCT02093039
2008-01
No
Not Provided
Not Provided
Institut de Cancérologie de la Loire
Institut de Cancérologie de la Loire
Not Provided
Principal Investigator: Franck CHAUVIN, MDPhD Institut de Cancérologie Lucien Neuwirth
Institut de Cancérologie de la Loire
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP