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

April 26, 2025 updated by: Suzanne C. O'Neill, Georgetown University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

995

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Washington
      • Seattle, Washington, United States, 28124
        • Kaiser Permanente Washington Health Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 69 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
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.
Active Comparator: 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.
Behavioral: Usual Care Arm
Health information provided by the American Cancer Society Website

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Distress Related to Cancer Risk
Time Frame: 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)."
6 weeks and 12 months
Number of Participants Receiving Breast MRI
Time Frame: 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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Georgetown University

Collaborators

Kaiser Permanente

Investigators

  • Principal Investigator: Suzanne C O'Neill, PhD, Georgetown University/Lombardi Comprehensive Cancer Center
  • Principal Investigator: Karen Wernli, PhD, Kaiser Permanente

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 15, 2017

Primary Completion (Actual)

May 15, 2019

Study Completion (Actual)

May 15, 2019

Study Registration Dates

First Submitted

January 18, 2017

First Submitted That Met QC Criteria

January 23, 2017

First Posted (Estimated)

January 24, 2017

Study Record Updates

Last Update Posted (Actual)

April 30, 2025

Last Update Submitted That Met QC Criteria

April 26, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2015-0687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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