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OpenTrials
Completed

NCT Number: NCT03029286

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

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.

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Key information

Age range

40 year–69 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Kaiser Permanente Washington Health Research Institute

Seattle, Washington, 28124, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Usual Care Arm

Behavioral

Health information provided by the American Cancer Society Website

Personalized Web Intervention Arm

Behavioral

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 outcomes

  1. 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

  1. 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)."

  2. 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.

Sponsors and collaborators

Lead sponsor

Georgetown University

Other

Collaborators

  • Kaiser Permanente

Registry information

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Jan 24, 2017
Registry last updated
Apr 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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