Mammography and Breast Arterial Calcification: An Information-Sharing Trial

NCT04983875 | Active Not Recruiting DMC

• 2 other identifiers: Study-21-00112R01CA251754
• Study Type: interventional
• Target: 5,492
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this research study was 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. Women are not currently routinely told whether or not they have BAC; that is, it's not part of standard national practice to communicate that information to patients. However, previous research has suggested that patients would like to be informed about the BAC status more often. In this study, the team had two goals. First, the team wanted to measure the rates of BAC in a large, representative sample of 5492 women. Second, the study team wanted to understand the effects of providing women with the BAC results as part of the standard post-mammography letter. Specifically, the study team wants to see how sharing BAC information might affect women's healthcare choices and lifestyle. The research includes 527 randomized women in this second part of the study, which is the first in the literature to explore women's reactions to the BAC results. If research shows that women find the information useful, BAC information may be given to women regularly in the future.

Conditions

Mammography; Vascular Calcification

Keywords

Mammography; Breast Arterial Calcification; Women's Health; Preventive Medicine; Behavioral Medicine; Screening

Outcome Measures

Primary Outcomes (1)

• Attendance at a cardiovascular appointment

  Patients will be asked a YES/NO question asking them to report whether they have seen a healthcare provider to talk about their heart or coronary artery disease in the last six months. Patient's self-report responses will be confirmed via medical record review.

  Month 6

Secondary Outcomes (6)

• Healthy Heart Score

  Baseline

• Healthy Heart Score

  Week 1

• Healthy Heart Score

  Month 6

• Detection of coronary artery disease (CAD)

  Month 6

• Revised Illness Perception Questionnaire (IPQ-R)

  Week 1

Study Arms (2)

BAC-enhanced group

EXPERIMENTAL

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

Behavioral: BAC-Enhanced Letter

Waitlist control group

OTHER

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).

Behavioral: BAC-Enhanced Letter; Behavioral: Waitlist Control

Interventions

BAC-Enhanced Letter BEHAVIORAL

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.

BAC-enhanced group; Waitlist control group

Waitlist Control BEHAVIORAL

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).

Waitlist control group

Eligibility Criteria

• Age: 40 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Mount Sinai

New York, New York, 10029, United States

Location

MeSH Terms

Conditions

Vascular Calcification

Condition Hierarchy (Ancestors)

Calcinosis; Calcium Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Guy H. Montgomery, Ph.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Department of Population Health Science and Policy

Study Record Dates

• First Submitted: July 22, 2021
• First Posted: July 30, 2021
• Study Start: September 29, 2021
• Primary Completion (Estimated): September 30, 2026
• Study Completion (Estimated): March 31, 2027
• Last Updated: April 16, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)