Colombian Screening Mammography Project

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

50 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Fred Hutchinson Cancer Research Center

Seattle, Washington, 98109, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Opportunistic Breast cancer screening

Other

Opportunistic breast screening offered to women attending clinics for non-breast health issues

Usual Care

Other

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

Primary outcomes

Breast cancer Incidence

Time frame: Two years

Comparing incidence of breast cancer in women randomized to the opportunistic breast screening arm, compared to women in the control arm.

Sponsors and collaborators

Lead sponsor

Fred Hutchinson Cancer Center

Other

Registry information

Official study title

Pilot Study for Implementing Breast Cancer Early Detection Programs in Colombia

Important dates

Study start: 2007
Primary completion: 2012
Study completion: 2014
First posted: Jan 13, 2015
Registry last updated: Jan 13, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed