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

Study Overview
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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.

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.

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

Conditions
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Breast Density, Breast Cancer Female

Intervention / Treatment
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* Behavioral: Usual Care Arm
* Behavioral: Personalized Web Intervention Arm


Participation Criteria
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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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Personalized Web Intervention Arm<br>Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors. | Behavioral: Personalized Web Intervention Arm<br>* Women will be assigned to view a tailored website featuring their personalized risk information for breast cancer related to breast density and other factors.<br>|
| Active Comparator: Usual Care Arm<br>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. | Behavioral: Usual Care Arm<br>* Health information provided by the American Cancer Society Website<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uptake of chemoprevention gathered via health plan pharmacy records at 12 months | Chemoprevention (raloxifine or tamoxifen) gathered via health plan pharmacy records at 12 months | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Distress gathered via self-report distress thermometer at 6-weeks and 12 months after recruitment | Distress via self-report distress thermometer | 6 weeks and 12 months | 
| Breast MRI gathered via health plan records at 12 months | Use of Breast MRI gathered via health plan records | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Breast Cancer, Breast Density