NCT03029286

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 995 (actual)
• Sponsor: Georgetown University · Academic / Other
• Sex: Female
• Age: 40 Years – 69 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• Breast Density
• Breast Cancer Female

Interventions

Type	Name	Description
BEHAVIORAL	Usual Care Arm	Health information provided by the American Cancer Society Website
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.

Timeline

• Start date: 2017-02-15
• Primary completion: 2019-05-15
• Completion: 2019-05-15
• First posted: 2017-01-24
• Last updated: 2025-04-30
• Results posted: 2025-04-30

Locations

1 site across 1 country: United States