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临床试验/NCT04983875
NCT04983875进行中(未招募)不适用

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

Icahn School of Medicine at Mount Sinai2 个研究点 分布在 1 个国家目标入组 5,492 人开始时间: 2021年9月29日最近更新:
适应症
干预措施

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

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

Experimental

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

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).

干预措施: Waitlist Control (Behavioral)

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).

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Guy Montgomery

Professor, Department of Population Health Science and Policy

Icahn School of Medicine at Mount Sinai

研究点 (2)

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