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

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 40
Healthy Volunteers: f
View:

• 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

Locations
United States
New York
Mount Sinai
RECRUITING
New York
Contact Information
Primary
Crystalinda Rapozo
crystalinda.rapozo@mssm.edu
212-659-5411
Backup
Julie B. Schnur, Ph.D.
julie.schnur@mssm.edu
Time Frame
Start Date: 2021-09-29
Estimated Completion Date: 2026-03-31
Participants
Target number of participants: 14875
Treatments
Experimental: BAC-enhanced group
944 participants will receive a post-mammography results letter which includes information on their BAC results.
Other: Waitlist control group
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).
Authors
Guy H. Montgomery
Related Therapeutic Areas
Sponsors
Leads: Icahn School of Medicine at Mount Sinai
Collaborators: National Cancer Institute (NCI)

This content was sourced from clinicaltrials.gov