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

Healthy Clinical Trial

— DECIDEO  

Official title:

Informed Decision Users of the Health System and Participation in Organized Screening for Breast Cancer : a Qualitative Analysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02093039
• Other study ID #: 2008-01
• Status: Completed
• Phase: N/A
• First received: March 19, 2014
• Last updated: March 19, 2014
• Start date: May 2009
• Est. completion date: June 2010

Study information

• Verified date: March 2014
• Source: Institut de Cancérologie de la Loire
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Comité consultatif sur le traitement de l'information en matière de recherche dans le domaine de la santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16000
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 74 Years

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Healthy

Intervention

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

Locations

Country	Name	City	State
France	Institut de Cancérologie Lucien Neuwirth	Saint-Priest-en-Jarez

Sponsors (1)

Lead Sponsor	Collaborator
Institut de Cancérologie de la Loire

Country where clinical trial is conducted

France, 

References & Publications (8)

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. Review. — View 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. — View 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. Review. — View 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. Epub 2006 Aug 14. — View 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. — View Citation

Olsson S, Andersson I, Karlberg I, Bjurstam N, Frodis E, Håkansson S. Implementation of service screening with mammography in Sweden: from pilot study to nationwide programme. J Med Screen. 2000;7(1):14-8. — View Citation

Raffle AE. Informed participation in screening is essential. BMJ. 1997 Jun 14;314(7096):1762-3. — View Citation

Walter LC, Lewis CL. Maximizing informed cancer screening decisions. Arch Intern Med. 2007 Oct 22;167(19):2027-8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	women's attendance rate for the breast cancer screening program during the 12 months following the invitation		12 months	No
Secondary	the delay between the invitation and the date of attendance for breast cancer screening		12 months	No