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

Georgetown University

Status: Completed

Conditions: Breast Cancer Female; Breast Density

Treatments: Behavioral: Usual Care Arm; Behavioral: Personalized Web Intervention Arm

Study type: Interventional

Funder types: Other

Identifiers

NCT03029286

2015-0687

Details and patient eligibility

About

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.

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.

Enrollment: 995 patients

Sex: Female

Ages: 40 to 69 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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995 participants in 2 patient groups

Personalized Web Intervention Arm

Experimental group

Description:

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

Treatment:

Behavioral: Personalized Web Intervention Arm

Usual Care Arm

Active Comparator group

Description:

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.

Treatment:

Behavioral: Usual Care Arm