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

Institut de Cancérologie de la Loire

Status: Completed

Conditions: Breast Cancer; Healthy

Treatments: Device: decision aid group

Study type: Interventional

Funder types: Other

Identifiers

NCT02093039

2008-01

Details and patient eligibility

About

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.

Enrollment: 16,000 patients

Sex: Female

Ages: 50 to 74 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16,000 participants in 2 patient groups

Decision aid group

Experimental group

Description:

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.

Treatment:

Device: decision aid group

Control group

No Intervention group

Description:

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