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Mammography and Breast Arterial Calcification: An Information-Sharing Trial
Sponsor: Icahn School of Medicine at Mount Sinai
Summary
The purpose of this research study is to determine the potential benefits of adding information on patients' breast arterial calcification (BAC) results to the standard results letter women receive after mammography. In addition to looking for potential breast cancer, research shows that mammograms can also detect the presence of calcifications within the breast arteries. Those calcifications can be associated with coronary artery disease. Right now, women are not routinely told whether or not they have BAC; that is, it's not part of standard practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about their BAC status more often. In this study, the team has two goals. First, the team wants to measure the rates of BAC in a large, representative group of 5708 women. Second, the study team wants to understand the effects of giving women information on their BAC results as part of their standard post-mammography letter. Specifically, the study team wants to see how sharing that information might affect women's healthcare choices and lifestyle. The research will include 508 women in this second part of the study, which will be the first in the literature to explore women's reactions to BAC information. If research shows that women find the information useful, BAC information may be given to women regularly in the future.
Official title: Enhancing the Public Health Benefits of Mammography Screening by Informing Women of Both Breast Cancer and Breast Arterial Calcification Results: A Randomized Trial to Promote Cardiovascular Health
Key Details
Gender
FEMALE
Age Range
40 Years - Any
Study Type
INTERVENTIONAL
Enrollment
5708
Start Date
2021-09-29
Completion Date
2027-03-31
Last Updated
2026-02-23
Healthy Volunteers
No
Conditions
Interventions
BAC-Enhanced Letter
The BAC-Enhanced Letter intervention includes enhancing the standard mammography results letter with a few additional lines of text informing patients of their personal BAC status.
Waitlist Control
Patients randomized to this group will receive a standard post-mammography results letter which does not include any information about their personal BAC status. However, participants randomized to this group will be informed of their personal BAC findings at the end of their study participation (approximately 6 months after mammography).
Locations (1)
Mount Sinai
New York, New York, United States