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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

995 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-02-15

Study Completion Date

2019-05-15

Brief Summary

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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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Detailed Description

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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.

Conditions

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Breast Density Breast Cancer Female

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Personalized Web Intervention Arm

Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.

Group Type EXPERIMENTAL

Personalized Web Intervention Arm

Intervention Type BEHAVIORAL

Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.

Usual Care Arm

Women will be assigned to view a website that will take them to the American Cancer Society website to view general risk information for breast cancer related to breast density.

Group Type ACTIVE_COMPARATOR

Usual Care Arm

Intervention Type BEHAVIORAL

Health information provided by the American Cancer Society Website

Interventions

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Usual Care Arm

Health information provided by the American Cancer Society Website

Intervention Type BEHAVIORAL

Personalized Web Intervention Arm

Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.

Minimum Eligible Age

40 Years

Maximum Eligible Age

69 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No