NCT02093039

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16,000

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started May 2009

Typical duration for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2010

Completed
3.8 years until next milestone

First Submitted

Initial submission to the registry

March 19, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 20, 2014

Completed
Last Updated

March 20, 2014

Status Verified

March 1, 2014

Enrollment Period

1.1 years

First QC Date

March 19, 2014

Last Update Submit

March 19, 2014

Conditions

HealthyBreast Cancer

Keywords

breast cancer screeningpatient decision aidsinformed decisionempowermentrandomized control trialFrom 50 to 74 years oldinvited to national breast cancer screening

Outcome Measures

Primary Outcomes (1)

  • women's attendance rate for the breast cancer screening program during the 12 months following the invitation

    12 months

Secondary Outcomes (1)

  • the delay between the invitation and the date of attendance for breast cancer screening

    12 months

Study Arms (2)

Decision aid group

EXPERIMENTAL

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

Control group

NO INTERVENTION

Women in the control group received an invitation and the usual standard information by mail.

Interventions

decision aid groupDEVICE

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

Decision aid group

Eligibility Criteria

Age50 Years - 74 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42270, France

Location

Related Publications (8)

  • 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.

    PMID: 22752881BACKGROUND

  • 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.

    PMID: 10807141BACKGROUND

  • 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.

    PMID: 17954794BACKGROUND

  • 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.

    PMID: 9202520BACKGROUND

  • 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.

    PMID: 15331483BACKGROUND

  • 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.

    PMID: 16908462BACKGROUND

  • 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.

    PMID: 17954796BACKGROUND

  • 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.

    PMID: 14512475BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsEmpowerment

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesSocial BehaviorBehavior

Study Officials

  • Franck CHAUVIN, MDPhD

    Institut de Cancérologie Lucien Neuwirth

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2014

First Posted

March 20, 2014

Study Start

May 1, 2009

Primary Completion

June 1, 2010

Study Completion

June 1, 2010

Last Updated

March 20, 2014

Record last verified: 2014-03

Locations

FR(1)