Clinical trial NCT04983875: Mammography and Breast Arterial Calcification: an Information-Sharing Trial
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mammography
Vascular Calcification
Keywords: Mammography
Breast Arterial Calcification
Women's Health
Preventive Medicine
Behavioral Medicine
Screening
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2021-07-30
Enrollment: 14875
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SCREENING

Brief 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, diverse group of 14,875 women. Because most of the past research on BAC has largely been focused on White mammography patients, the researchers feel it is important to see if the results are similar or different in a more racially and ethnically diverse sample.

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 1,888 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.


Eligibility 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

Primary outcomes:
measure: Attendance at a cardiovascular appointment
timeFrame: Month 6
Secondary outcomes:
measure: Healthy Heart Score
timeFrame: Baseline
measure: Healthy Heart Score
timeFrame: Week 1
measure: Healthy Heart Score
timeFrame: Month 6
measure: Detection of coronary artery disease (CAD)
timeFrame: Month 6
measure: Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: Week 1
measure: Revised Illness Perception Questionnaire (IPQ-R)
timeFrame: Month 6
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Guy H. Montgomery, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: