Colombian Screening Mammography Project
Pilot Study for Implementing Breast Cancer Early Detection Programs in Colombia
2 other identifiers
interventional
15,855
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Jan 2007
Longer than P75 for not_applicable breast-cancer
1 active site
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
January 1, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedFirst Submitted
Initial submission to the registry
January 9, 2015
CompletedFirst Posted
Study publicly available on registry
January 13, 2015
CompletedJanuary 13, 2015
January 1, 2015
5.9 years
January 9, 2015
January 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
Intervention
ACTIVE COMPARATORControl
OTHERInterventions
Opportunistic breast screening offered to women attending clinics for non-breast health issues
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- see above
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fred Hutchinson Cancer Research Center
Seattle, Washington, 98109, United States
Related Publications (1)
Murillo R, Diaz S, Perry F, Poveda C, Pineros M, Sanchez O, Buitrago L, Gamboa O, Lozano T, Yu H, Wang CY, Duggan C, Thomas DB, Anderson BO. Increased breast cancer screening and downstaging in Colombian women: A randomized trial of opportunistic breast-screening. Int J Cancer. 2016 Feb 1;138(3):705-13. doi: 10.1002/ijc.29801. Epub 2015 Sep 2.
PMID: 26264446DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- SCREENING
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 9, 2015
First Posted
January 13, 2015
Study Start
January 1, 2007
Primary Completion
December 1, 2012
Study Completion
August 1, 2014
Last Updated
January 13, 2015
Record last verified: 2015-01