Applying Breast Density to Risk Counseling

将乳房密度应用于风险咨询

• 批准号: 9122396
• 负责人: Suzanne C. O'Neill
• 金额: $ 52.89万
• 依托单位: GEORGETOWN UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2015
• 资助国家: 美国
• 起止时间: 2015-08-07 至 2019-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9122396
• 关键词: Affect; Affordable Care Act; American Cancer Society; Awareness; Benefits and Risks; Breast; Breast Cancer Risk Factor; Cancer Intervention and Surveillance Modeling Network; Caring; Categories; Chemoprevention; Clinical; Communication; Costs and Benefits; Counseling; Data; Decision Aid; Disclosure; Distress; Family; Geographic state; Goals; Guidelines; Health; Health Care Costs; High Risk Woman; Individual; International; Internet; Intervention; Lead; Magnetic Resonance Imaging; Malignant Neoplasms; Mammary Gland Parenchyma; Mammography; Measures; Mediating; Mediator of activation protein; Methods; Motivation; Online Systems; Pacific Northwest; Participant; Patient Self-Report; Patients; Perception; Policies; Population; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Recruitment Activity; Reporting; Risk; Risk Estimate; Risk Factors; Risk Management; Risk-Taking; Self Efficacy; Self Perception; Services; Severities; Statutes and Laws; System; Tamoxifen; Telephone Interviews; Time; Vacuum; Woman; aged; arm; base; breast density; breast imaging; cancer risk; care delivery; coping; cost; cost effectiveness; density; disorder risk; economic evaluation; economic impact; effective intervention; health care service utilization; health literacy; high risk; improved; interest; intervention effect; life time cost; literacy; malignant breast neoplasm; mathematical ability; member; multidisciplinary; network models; novel strategies; preference; response; screening; theories; treatment as usual; uptake; web site

 DESCRIPTION (provided by applicant): Many of the over 232,000 women who developed invasive breast cancer last year were unaware of disease risk factors, their personal risk, and available risk management strategies. Along with better-known risk factors such as family history, having dense breasts ("density") is one of the strongest breast cancer risk factors. Almost half of US states now require disclosure of density status following routine screening mammography. Disclosure provides an opportunity to capture women who are at clinically elevated risk due to density and additional risk factors, such as family history, and to inform them of risk management options available to them. Guidelines have long recommended risk counseling for women with clinically elevated breast cancer risk, including discussion of chemoprevention and additional breast imaging such as MRI. While uptake is an individual, preference-based decision, population use of these risk management options is low and efforts to improve uptake are limited. Our pilot data suggest that patients have strong interest in density-focused risk counseling and that our pilot intervention can shift risk management intentions. These data, together with the confluence of mandatory density reporting, expanded risk management guidelines, and coverage of services under the ACA provides an unprecedented opportunity to expand breast cancer risk management and to assess the economic impact. We propose the first randomized controlled trial to evaluate a method of density disclosure. Our goal is to encourage uptake of guideline-informed risk management without increasing distress. Guided by Protection Motivation Theory, we will implement and evaluate a web-based interactive intervention vs. usual care among members of Group Health (aged 40-69) whose high breast density and other risk factors place them at high 5-year (>1.66 percent) or lifetime (>20 percent) risk for breast cancer. We will assess the mechanisms of intervention effect and conduct an economic evaluation alongside the trial. Patients will complete assessments at pre-randomization baseline, as well as 6 weeks and 12 months post-randomization. We will integrate these self-report data with healthcare utilization and cost data to assess the potential public health impact of our intervention. Our aims are to 1) assess intervention effects on uptake and distress, 2) identify mediators/moderators of intervention impact on uptake, and 3) extend the time horizon of the trial to estimate the lifetime costs, benefits, and harms of the intervention from different perspectives using a Cancer Intervention and Surveillance Modeling Network (CISNET) model. Our trial will move the field forward by informing the sweeping national policy integration requiring density disclosure and estimating the cost-effectiveness of our approach.

 描述（由申请人提供）：去年发生浸润性乳腺癌的232，000多名妇女中，许多人不知道疾病风险因素，个人风险和可用的风险管理策略。沿着众所周知的风险因素，如家族史，有致密乳房（“密度”）是最强的乳腺癌风险因素之一。几乎一半的美国州现在要求披露常规筛查乳房X光检查后的密度状态。披露提供了一个机会，以捕捉妇女谁是在临床上高风险，由于密度和其他风险因素，如家族史，并告知他们的风险管理选项提供给他们。长期以来，指南一直建议为临床上乳腺癌风险升高的女性提供风险咨询，包括讨论化学预防和额外的乳腺成像，如MRI。虽然采用是一个基于个人偏好的决定，但这些风险管理选择的人群使用率很低，提高采用率的努力有限。我们的试点数据表明，患者对以密度为中心的风险咨询有浓厚的兴趣，我们的试点干预可以改变风险管理的意图。这些数据，加上强制性密度报告，扩大风险管理指南和ACA下的服务覆盖范围的汇合，为扩大乳腺癌风险管理和评估经济影响提供了前所未有的机会。我们提出了第一个随机对照试验，以评估密度披露的方法。我们的目标是鼓励在不增加痛苦的情况下采用指导性风险管理。在保护动机理论的指导下，我们将在健康小组（40-69岁）的成员中实施和评估基于网络的互动干预与常规护理，这些成员的高乳腺密度和其他风险因素使他们在5年（> 1.66%）或终身（> 20%）患乳腺癌的风险很高。我们将评估干预效果的机制，并在试验的同时进行经济评估。患者将在随机化前基线以及随机化后6周和12个月完成评估。我们将把这些自我报告数据与医疗利用和成本数据相结合，以评估我们的干预措施对公共卫生的潜在影响。我们的目标是1）评估干预对摄取和痛苦的影响，2）确定干预对摄取影响的中介者/调节者，3）延长试验的时间范围，使用癌症干预和监测建模网络（CISNET）模型从不同角度估计干预的终身成本，收益和危害。我们的试验将通过通知要求密度披露的全面国家政策整合和估计我们方法的成本效益来推动该领域的发展。