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
试验速览
- 阶段
- 不适用
- 状态
- 进行中(未招募)
- 入组人数
- 5,492
- 试验地点
- 2
- 主要终点
- Attendance at a cardiovascular appointment
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 40 Years 至 —(Adult, Older Adult)
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
BAC-enhanced group
Participants will receive a post-mammography results letter which includes information on their BAC results.
干预措施: BAC-Enhanced Letter (Behavioral)
Waitlist control group
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).
干预措施: Waitlist Control (Behavioral)
Waitlist control group
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).
干预措施: BAC-Enhanced Letter (Behavioral)
结局指标
主要结局
Attendance at a cardiovascular appointment
时间窗: Month 6
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.
次要结局
- Healthy Heart Score(Month 6)
- Detection of coronary artery disease (CAD)(Month 6)
- Revised Illness Perception Questionnaire (IPQ-R)(Month 6)
- Healthy Heart Score(Baseline)
- Healthy Heart Score(Week 1)
- Revised Illness Perception Questionnaire (IPQ-R)(Week 1)
研究者
Guy Montgomery
Professor, Department of Population Health Science and Policy
Icahn School of Medicine at Mount Sinai
