Colombian Screening Mammography Project

Breast Cancer Clinical Trial

Official title:

Pilot Study for Implementing Breast Cancer Early Detection Programs in Colombia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02337582
• Other study ID #: SAC110001
• Secondary ID: 6465
• Status: Completed
• Phase: N/A
• First received: January 9, 2015
• Last updated: January 9, 2015
• Start date: January 2007
• Est. completion date: August 2014

Study information

• Verified date: January 2015
• Source: Fred Hutchinson Cancer Research Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States of America: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

A cluster randomized controlled trial was performed in Bogotá, Colombia between 2007-2008 to evaluate the effects of an opportunistic (hospital-based) screening program (intervention) vs. usual care (control) in which 26 clinics were randomized to an intervention (N=13) or control arm (N=13). At intervention clinics general practitioners were instructed to perform clinical breast examination (CBE) on all women aged 50-69 years attending clinics for non-breast health related issues, and to refer them for mammographic screening. Physicians from control clinics were not specifically instructed to perform breast-screening or refer women for mammography, but could do so if they thought it appropriate ('usual care'). Women were followed for 2 years post-randomization.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15855
• Est. completion date: August 2014
• Est. primary completion date: December 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 50 Years to 69 Years

Eligibility

Inclusion Criteria:

Female Aged 50-69 Resident in Bogotá, Colombia or surrounding cities; Had not had a mammogram in the previous two years; No history of breast cancer Attending health-centers for reasons unrelated to breast health

Exclusion Criteria:

• see above

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Screening

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Other:
• Opportunistic Breast cancer screening
Opportunistic breast screening offered to women attending clinics for non-breast health issues
• Usual Care
No breast screening was explicitly offered to women attending clinics for non-breast health issues, unless the health care provider felt that it was appropriate

Locations

Country	Name	City	State
United States	Fred Hutchinson Cancer Research Center	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
Fred Hutchinson Cancer Research Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Breast cancer Incidence	Comparing incidence of breast cancer in women randomized to the opportunistic breast screening arm, compared to women in the control arm.	Two years	No