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

通过告知女性乳腺癌和乳腺动脉钙化结果，增强乳房 X 光检查的公共健康益处：一项促进心血管健康的随机试验

• 批准号: 10380781
• 负责人: Guy H Montgomery
• 金额: $ 68.6万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2022
• 资助国家: 美国
• 起止时间: 2022-04-01 至 2026-03-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10380781
• 关键词: Affect; Appointment; Arteries; Behavior; Breast; Breast Cancer Detection; Cardiac Death; Cardiology; Cardiovascular Diseases; Cardiovascular system; Caring; Cause of Death; Communication; Communities; Complement; Consent; Control Groups; Coronary Arteriosclerosis; Coronary artery; Data; Demographic Factors; Detection; Diagnosis; Diet; Digital Mammography; Ensure; Ethnic Origin; Failure; General Population; Goals; Health Benefit; Health behavior; Heart; Image; Intervention; Intervention Studies; Learning; Length; Letters; Life Style; Literature; Malignant Neoplasms; Mammographic screening; Mammography; Measures; Mediating; Medical; Modeling; Myocardial; Myocardial Infarction; Outcome; Outcome Study; Participant; Patient Preferences; Patients; Population Study; Postmenopause; Prevalence; Prevention; Preventive; Preventive care; Process; Psychological Factors; Public Health; Race; Radiation; Randomized; Recommendation; Reporting; Research; Sampling; Screening for cancer; Screening procedure; Symptoms; Testing; Text; Time; United States; Visit; Waiting Lists; Woman; Women' s Health; base; calcification; cancer prevention; cardiovascular health; coronary artery calcification; design; disorder risk; ethnic diversity; follow-up; health data; improved; innovation; lifestyle factors; malignant breast neoplasm; primary outcome; racial diversity; radiologist; randomized trial; recruit; routine screening; screening

Breast mammography is one of the most successful cancer screening tools in the cancer prevention arsenal. 37 million women in the US will receive a mammogram this year, and following that, these women will receive a letter letting them know whether they do or do not have evidence of breast cancer. Recent research indicates that standard digital mammography also yields additional information critical to women’s health; that is, information about the presence of calcifications within breast arteries - 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). Research indicates that at least 12.7% of women’s mammograms reveal BAC – about 1 in 8. Of those with BAC, 32%-96% have CAD. Thus, conservatively, mammography could detect over 1.5 million cases of CAD each year. Despite this potential public health boon, BAC information is not directly communicated to patients in the post-mammography letter. The failure to communicate BAC status is a missed opportunity to inform women about CAD risk, and is inconsistent with patient preferences. The goal of this proposal is to investigate whether provision of BAC information to women post-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 women to seek preventive cardiology care, and provides cardiology referral information; or 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. Also, most BAC prevalence literature has been conducted on predominantly white samples. To remedy this, 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, and the first to report BAC prevalence in a racially and ethnically diverse sample. Public health impact: The project is a first step towards ensuring that women benefit directly from all of the rich health data that mammography can yield.

乳房 X 光检查是癌症预防手段中最成功的癌症筛查工具之一，今年将有 3700 万美国女性接受乳房 X 光检查，随后，这些女性将收到一封信，告知她们是否接受过乳房 X 光检查。最近的研究表明，标准数字乳房 X 光检查还可以提供对女性健康至关重要的额外信息，即有关乳腺动脉内是否存在钙化的信息 - 乳腺动脉钙化 (BAC)。 BAC 的存在与冠状动脉内的钙化有关，这是冠状动脉疾病 (CAD) 的一个标志 研究表明，至少 12.7% 的女性乳房 X 光检查显示 BAC（大约八分之一）。在患有 BAC 的女性中，这一比例为 32%。因此，保守地说，乳房 X 光检查每年可以检测出超过 150 万例 CAD，尽管这对公共卫生有潜在好处，但 BAC 信息并未直接传达给患者。乳房 X 光检查后未告知 BAC 状态是一个向女性告知 CAD 风险的机会，并且与患者的偏好不一致。本提案的目的是调查在乳房 X 光检查后向女性提供 BAC 信息是否会影响她们的情况。我们将把影像显示 BAC 的乳房 X 光检查患者（N = 1,889，讲英语和西班牙语）随机分为以下任一组：a) BAC 增强字母条件，告知女性其阳性 BAC 结果和 BAC-CAD。协会，鼓励女性寻求预防性心脏病护理，并提供心脏病转诊信息；或 b) 等待名单控制条件，患者最初收到标准乳房 X 光检查信函，并在 6 个月后了解其 BAC 状态。增强信将更有可能参加心血管健康预约（主要结果），从事心脏健康行为，并检测出 CAD 在常识模型的指导下，我们试图了解哪些心理因素介导了干预和治疗之间的关系。结果。此外，大多数 BAC 患病率文献都是针对以白人为主的样本进行的，为了解决这个问题，我们将描述一个大型、种族和民族多样化的样本 (N=14,875) 中的 BAC 患病率。 创新：这将是第一项针对 BAC 干预的研究。以“直接向消费​​者”的方式与接受乳房 X 光检查的女性直接分享 BAC 信息，并且是第一个报告不同种族和民族样本中 BAC 患病率的公共卫生影响的项目：该项目是确保女性直接受益的第一步。富人的乳房X线照相术可以产生健康数据。