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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.
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire Identifier:
First received: March 19, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
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.

Condition Intervention
Breast Cancer
Device: decision aid group

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis

Resource links provided by NLM:

Further study details as provided by Institut de Cancérologie de la Loire:

Primary Outcome Measures:
  • women's attendance rate for the breast cancer screening program during the 12 months following the invitation [ Time Frame: 12 months ]

Secondary Outcome Measures:
  • the delay between the invitation and the date of attendance for breast cancer screening [ Time Frame: 12 months ]

Enrollment: 16000
Study Start Date: May 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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
No Intervention: Control group
Women in the control group received an invitation and the usual standard information by mail.


Ages Eligible for Study:   50 Years to 74 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

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

Exclusion Criteria:

  Contacts and Locations
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Please refer to this study by its identifier: NCT02093039

Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, France, 42270
Sponsors and Collaborators
Institut de Cancérologie de la Loire
Principal Investigator: Franck CHAUVIN, MDPhD Institut de Cancérologie Lucien Neuwirth
  More Information


Responsible Party: Institut de Cancérologie de la Loire Identifier: NCT02093039     History of Changes
Other Study ID Numbers: 2008-01
Study First Received: March 19, 2014
Last Updated: March 19, 2014

Keywords provided by Institut de Cancérologie de la Loire:
breast cancer screening
patient decision aids
informed decision
randomized control trial
From 50 to 74 years old
invited to national breast cancer screening

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases processed this record on May 22, 2017