Breast Cancer Clinical Trial

ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2

Summary

This trial will test a decision support web based intervention for women at increased risk for breast cancer due to breast density and other risk factors (age, race/ethnicity, family history of breast cancer, history of prior breast biopsies), and to consider MRI and/or chemoprevention to manage their breast cancer risk.

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Full Description

Along with better-known risk factors such as family history having dense breasts is one of the strongest breast cancer risk factors. Extremely dense breast tissue affects about 10% of women, with an additional third having heterogeneously dense breasts. Women in these categories have 3-6 times the risk of breast cancer as compared to women with least density. Although breast density is measured on routine screening mammograms, it is not typically communicated to patients. This is changing as a result of legal mandates and approaches need to be tested to effectively integrate this clinical information in care. Therefore,we have developed an intervention to support decision making about cancer risk management (MRI and chemoprevention) for women at clinically elevated risk using a web-based intervention that will evaluate the efficacy of a web based intervention with personalized risk information communication versus usual care.

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Eligibility Criteria

Inclusion Criteria:

Women, aged 40-69
Enrolled at Group Health
Have had a negative mammogram as part of their routine care
Either (a) an intermediate 5-year risk (>1.67%-2.49%) and extremely dense breasts or (b) a high 5-year risk (≥2.50%) and either heterogeneously dense or extremely dense breasts utilizing the Breast Cancer Surveillance Consortium Risk Calculator (http://tools.bcsc-scc.org/BC5yearRisk/)
Women must also have a valid email address.

Exclusion Criteria:

Not able to speak and read English
History of LCIS
Prior cancer diagnosis (including DCIS)
Known BRCA1/2 family mutation, or previous receipt of cancer genetic counseling
Do not want to be contacted for research
Have previously participated in intervention development activities
Dis-enrolled from health plan between mammogram and start of recruitment.

Study is for people with:

Breast Cancer

Estimated Enrollment:

995

Study ID:

NCT03029286

Recruitment Status:

Completed

Sponsor:

Georgetown University

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There is 1 Location for this study

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Kaiser Permanente Washington Health Research Institute
Seattle Washington, 28124, United States

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Estimated Enrollment:

995

Study ID:

NCT03029286

Recruitment Status:

Completed

Sponsor:


Georgetown University

How clear is this clinincal trial information?

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