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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:
Information provided by (Responsible Party):
Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier:
NCT02093039
First received: March 19, 2014
Last updated: NA
Last verified: March 2014
History: No changes posted
  Purpose

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
Healthy
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • the delay between the invitation and the date of attendance for breast cancer screening [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   50 Years to 74 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02093039

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

Publications:

Responsible Party: Institut de Cancérologie de la Loire
ClinicalTrials.gov Identifier: NCT02093039     History of Changes
Other Study ID Numbers: 2008-01
Study First Received: March 19, 2014
Last Updated: March 19, 2014
Health Authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé

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

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014