ENGAGED 2 Study: Experiences With Mammography Screening and Breast Density 2
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Georgetown University
- Enrollment
- 995
- Locations
- 1
- Primary Endpoint
- Number of Participants Taking Chemoprevention at 12 Months
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- None (Participant)
Eligibility Criteria
- Ages
- 40 Years to 69 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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: Personalized Web Intervention Arm (Behavioral)
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.
Intervention: Usual Care Arm (Behavioral)
Outcomes
Primary Outcomes
Number of Participants Taking Chemoprevention at 12 Months
Time Frame: 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 Outcomes
- Distress Related to Cancer Risk(6 weeks and 12 months)
- Number of Participants Receiving Breast MRI(12 months)
Investigators
Suzanne C. O'Neill
Associate Professor
Georgetown University