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

Breast Cancer Female Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03029286
• Other study ID #: 2015-0687
• Status: Completed
• Phase: N/A
• Start date: February 15, 2017
• Est. completion date: May 15, 2019

Study information

• Verified date: January 2020
• Source: Georgetown University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 995
• Est. completion date: May 15, 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years to 69 Years

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:

• 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.

Related Conditions & MeSH terms

• Breast Cancer Female
• Breast Density
• Breast Neoplasms

Intervention

Behavioral:
• Usual Care Arm
Health information provided by the American Cancer Society Website
• 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.

Locations

Country	Name	City	State
United States	Kaiser Permanente Washington Health Research Institute	Seattle	Washington

Sponsors (2)

Lead Sponsor	Collaborator
Georgetown University	Kaiser Permanente

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Breast MRI gathered via health plan records at 12 months	Use of Breast MRI gathered via health plan records	12 months