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

Not Applicable

Completed

Interventions: Behavioral: Usual Care Arm
Behavioral: Personalized Web Intervention Arm

Brief 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
Usual Care Arm	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.
Personalized Web Intervention Arm	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.

Primary Outcome Measures

Name	Time	Method
Number of Participants Taking Chemoprevention at 12 Months	12 months	Number of Participants who initiated chemoprevention is measured as receipt of any prescription for tamoxifen or raloxifene, based on health plan pharmacy data at any time from consent through 12 months.

Secondary Outcome Measures

Name	Time	Method
Distress Related to Cancer Risk	6 weeks and 12 months	Distress was measured with the item, "Please choose the number (from 0-10) that best describes how much distress you have been experiencing related to your cancer risk in the past week including today, from 0 (no distress) to 10 (extreme distress)."
Number of Participants Receiving Breast MRI	12 months	Number of participants receiving breast MRI was assessed using EHR data on receipt of breast imaging within network or claims data from outside imaging facilities.