Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label

Outcome Measure:

Change from baseline in knowledge of women participating in the screening program

Outcome Description:

The primary outcome measure is the level of knowledge obtained in a specific questionnaire, in which there are 7 questions, of which 3 are quantitative with no assumptions and are scored with 2 points. There are also 4 qualitative questions that have 3 assumptions which are scored with 1 point. The maximum score is 10 and minimum 0. It is considered that a woman has made ​​a choice based on adequate knowledge if she gets a score of 6 or more.

Outcome Time Frame:

Before randomization (baseline) and one month later

Safety Issue:

No

Principal Investigator

José M Baena-Cañada, MD, PhD

Investigator Role:

Study Chair

Investigator Affiliation:

Oncology Unit, University Hospital Puerta del Mar, Cádiz

Authority:

Spain: Ministry of Health and Consumption

Study ID:

PI-0315-2010

NCT ID:

NCT01335906

Start Date:

January 2011

Completion Date:

December 2013

Related Keywords:

• Early Detection of Cancer
• Cancer Screening Tests
• Early Diagnosis of Cancer
• Mammography
• Informed Consent
• Consent Forms