R01CA251754

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

Breast mammography is one of the most successful cancer screening tools in the cancer prevention arsenal. This year, 37 million women in the US will receive a mammogram. Following the mammogram, these women will receive a letter informing them whether they have evidence of breast cancer or not.

Recent research indicates that standard digital mammography also provides additional information critical to women's health. This information pertains to the presence of calcifications within breast arteries, known as Breast Arterial Calcification (BAC). The presence of BAC has been associated with calcification within coronary arteries, which is a marker of Coronary Artery Disease (CAD). Approximately 12.7% of women's mammograms reveal BAC, which means that about 1 in 8 women have BAC. Among those with BAC, 32%-96% also have CAD. Therefore, mammography has the potential to detect over 1.5 million cases of CAD each year.

Despite this potential public health benefit, BAC information is not directly communicated to patients in the post-mammography letter. This failure to communicate BAC status is a missed opportunity to inform women about their CAD risk and is inconsistent with patient preferences.

The goal of this proposal is to investigate whether providing BAC information to women after mammography influences their cardiovascular health behaviors. We will randomize mammography patients whose imaging reveals BAC (N=1,889, English and Spanish-speaking) to either:

A) The BAC-enhanced letter condition, which informs women about their positive BAC findings and the BAC-CAD association, encourages them to seek preventive cardiology care, and provides cardiology referral information.

B) The waitlist control condition, where patients receive a standard mammography letter initially and learn their BAC status 6 months later.

We hypothesize that women who receive the BAC-enhanced letter will be more likely to attend a cardiovascular health appointment (primary outcome), engage in heart-healthy behavior, and have CAD detected. Guided by the Common Sense Model, we seek to understand which psychological factors mediate the relationship between the intervention and the outcomes.

Additionally, most BAC prevalence literature has been conducted on predominantly white samples. To address this gap, we will describe BAC prevalence in a large, racially and ethnically diverse sample (N=14,875).

Innovation: This will be the first study of an intervention to directly share BAC information with women undergoing mammography in a "direct to consumer" approach. It will also be the first to report BAC prevalence in a racially and ethnically diverse sample.

Public Health Impact: This project is a first step towards ensuring that women directly benefit from all the rich health data that mammography can yield.

Icahn School Of Medicine At Mount Sinai

TO IDENTIFY CANCER RISKS AND RISK REDUCTION STRATEGIES, TO IDENTIFY FACTORS THAT CAUSE CANCER IN HUMANS, AND TO DISCOVER AND DEVELOP MECHANISMS FOR CANCER PREVENTION AND PREVENTIVE INTERVENTIONS IN HUMANS. RESEARCH PROGRAMS INCLUDE: (1) CHEMICAL, PHYSICAL AND MOLECULAR CARCINOGENESIS, (2) SCREENING, EARLY DETECTION AND RISK ASSESSMENT, INCLUDING BIOMARKER DISCOVERY, DEVELOPMENT AND VALIDATION, (3) EPIDEMIOLOGY, (4) NUTRITION AND BIOACTIVE FOOD COMPONENTS, (5) IMMUNOLOGY AND VACCINES, (6) FIELD STUDIES AND STATISTICS, (7) CANCER CHEMOPREVENTION AND INTERCEPTION, (8) PRE-CLINICAL AND CLINICAL AGENT DEVELOPMENT, (9) ORGAN SITE STUDIES AND CLINICAL TRIALS, (10) HEALTH-RELATED QUALITY OF LIFE AND PATIENT-CENTERED OUTCOMES, AND (11) SUPPORTIVE CARE AND MANAGEMENT OF SYMPTOMS AND TOXICITIES. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM: TO EXPAND AND IMPROVE THE SBIR PROGRAM, TO STIMULATE TECHNICAL INNOVATION, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS. SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM: TO STIMULATE AND FOSTER SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT FUNDING, AND FOSTER PARTICIPATION IN INNOVATION AND ENTREPRENEURSHIP BY WOMEN AND SOCIALLY/ECONOMICALLY DISADVANTAGED PERSONS.

93.393 - Cancer Cause and Prevention Research

National Cancer Institute (NCI) [HHS - NIH]

New York, New York 100296504 United States

Single Zip Code

Cancer Prevention and Control Clinical Trials Grant Program (R01 Clinical Trial Required) (PAR-18-559)

Amendment Since initial award the total obligations have increased 389% from $702,634 to $3,435,650.