Colombian Screening Mammography Project

NCT ID: NCT02337582

Last Updated: 2015-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15855 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2014-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SCREENING

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention

Group Type ACTIVE_COMPARATOR

Opportunistic Breast cancer screening

Intervention Type OTHER

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

Control

Group Type OTHER

Usual Care

Intervention Type 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

Interventions

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Opportunistic Breast cancer screening

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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

50 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Fred Hutchinson Cancer Center

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Fred Hutchinson Cancer Research Center

Seattle, Washington, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 26264446 (View on PubMed)

Other Identifiers

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6465

Identifier Type: OTHER

Identifier Source: secondary_id

SAC110001

Identifier Type: -

Identifier Source: org_study_id

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