Mammography and Breast Arterial Calcification: An Information-Sharing Trial

Mount Sinai Health System

Status: Enrolling

Conditions: Vascular Calcification; Mammography

Treatments: Behavioral: Waitlist Control; Behavioral: BAC-Enhanced Letter

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04983875

R01CA251754 (U.S. NIH Grant/Contract)

Study-21-00112

Details and patient eligibility

About

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 3,700 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 400 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.

Enrollment: 37,000 estimated patients

Sex: Female

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Female
• Scheduled to undergo mammography at one of Mount Sinai's breast radiology clinics (e.g., Dubin Breast Center, Radiology Associates)
• Age ≥ 40 years
• Read and speak English or Spanish
• Ability to understand and the willingness to sign a written informed consent
• Willing to sign and date any applicable medical record release documents for the study

Exclusion Criteria:

• Participants with known coronary artery disease (via self-report)
• Previous physician-diagnosed heart attack, stroke or TIA, heart failure, angina or taking nitroglycerin, or atrial fibrillation (via self-report or review of EMR)
• Inability to understand and comply with the instructions of the study due to the presence of cognitive or psychiatric conditions (such as dementia, psychosis, or mania), compromising ability to provide informed consent and/or follow study procedures
• Pregnant women

Trial design

Primary purpose: Screening

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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37,000 participants in 2 patient groups

BAC-enhanced group

Experimental group

Description:

944 participants will receive a post-mammography results letter which includes information on their BAC results.

Treatment:

Behavioral: BAC-Enhanced Letter

Waitlist control group

Other group

Description:

944 participants will receive a post-mammography results letter without BAC information, which is the current standard of care. These patients will receive BAC information following study completion (approximately 6 months after mammography).

Treatment:

Behavioral: BAC-Enhanced Letter

Behavioral: Waitlist Control