Facilitating Informed Decisions for Contralateral Prophylactic Mastectomy

促进对侧预防性乳房切除术的明智决策

基本信息

批准号：
9119788
负责人：
Laurie Kirstein
金额：
$ 14.46万
依托单位：
RBHS -CANCER INSTITUTE OF NEW JERSEY
依托单位国家：
美国
项目类别：
财政年份：
2015
资助国家：
美国
起止时间：
2015-08-15 至 2018-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9119788
关键词：
Address Anxiety Benefits and Risks Body part Breast Breast Cancer Patient Clinical Complex Conflict (Psychology)Contralateral Contralateral Breast Counseling Data Decision Aid Decision Making Development Diagnosis Disadvantaged Distress Education Equilibrium Excision Face Family history of Feedback Fright Future Health Health Personnel Intention Internet Intervention Interview Knowledge Lead Life Malignant Neoplasms Mammaplasty Mastectomy Medical Metastatic breast cancer Morbidity - disease rate Motivation Neoplasm Metastasis Online Systems Operative Surgical Procedures Outcome Patient Education Patients Perception Phase Population Procedures Process Qualitative Methods Randomized Clinical Trials Readiness Recurrence Reporting Research Research Personnel Risk Self Efficacy Self Perception Surgeon Time Uncertainty Weighing patient Woman base breast cancer diagnosis cancer recurrence cancer risk coping design emotional distress improved malignant breast neoplasm medically necessary care pressure prophylactic prototype reconstruction treatment as usual

项目摘要

DESCRIPTION (provided by applicant): The use of contralateral prophylactic mastectomy (CPM), which is removal of the healthy breast in a woman with unilateral breast cancer, has risen five-fold in the past 15 years. Although a case can be made for CPM among women with a strong family history of breast cancer, CPM is not recommended for women diagnosed with sporadic breast cancer. The dramatic increase in CPM is due to women with sporadic breast cancer choosing CPM. There are a number of reasons women at sporadic risk choose CPM. It is thought that CPM is considered more acceptable due to technical advances that have resulted in improved breast reconstruction outcomes and because high profile celebrities chose CPM. The primary reason women choose CPM is that breast cancer triggers considerable distress and uncertainty about whether breast cancer may return, either to the healthy breast or to another part of the body. This may motivate patients to choose the more aggressive treatments regardless of their risks and benefits. Uncertainty about cancer recurrence may also motivate women to choose CPM to reduce this worry, even when women realize they are not at significant risk for a cancer in the other breast and that CPM will not impact their survival. Patients may be less likely to heed their surgeons' advice that CPM is not medically indicated. There is a clinical need for greater patient education regarding the decision to undergo an aggressive and permanent intervention that is accompanied by significant morbidity and potential complications. The decision to have CPM among women with sporadic breast cancer places patients' desires for relief of anxiety and uncertainty above data suggesting that these women do not have a significant risk for cancer in the healthy breast and the fact that CPM does not confer a survival benefit. In situations when patients face complex decisions where they need to weigh the risks and benefits of choices, decision support aids (DA) can be helpful to promote a well-informed choice. Toward this end, we propose to develop a theoretically guided, web-based CPM-DA for women with sporadic breast cancer who are considering CPM to promote informed decision making. We will accomplish this in two phases. Phase 1 is a developmental phase where the DA content is developed based upon interviews with women who have undergone or chosen not to have CPM. These data will be analyzed using qualitative methods. Next, the team will develop the CPM-DA, gather feedback about it from patients, and finalize the CPM-DA. Phase 2 will be a small randomized clinical trial of the CPM-DA comparing it with Usual Care among 80 women considering CPM. The primary aim is to evaluate the feasibility and acceptability of the CPM-DA. The secondary aim is to provide preliminary data on the impact of the CPM-DA on preparedness to make the decision about CPM, CPM knowledge, self-efficacy for managing worry and surveillance, perceived cancer risk, worry about recurrence, decisional conflict, and CPM intention.

描述（由申请人提供）：对侧预防性乳房切除术 (CPM)（即切除患有单侧乳腺癌的女性的健康乳房）的使用率在过去 15 年中增加了五倍，尽管这是有道理的。对于有明显乳腺癌家族史的女性，不建议诊断为散发性乳腺癌的女性选择CPM。 CPM 的急剧增加是由于患有散发性乳腺癌的女性选择了CPM。零星风险女性选择 CPM 的原因之一人们认为 CPM 被认为更容易接受，因为技术进步改善了乳房重建结果，而且知名人士选择 CPM 的主要原因是乳腺癌会引发相当大的癌症。乳腺癌是否会复发（无论是在健康的乳房还是身体的其他部位）的痛苦和不确定性可能会促使患者选择更积极的治疗，而不管癌症复发的风险和益处如何，也可能会促使女性选择更积极的治疗。 CPM 可以减少这种担忧，甚至当女性意识到她们的另一侧乳房没有患癌症的重大风险并且 CPM 不会影响她们的生存时，患者可能不太可能听从外科医生关于 CPM 没有医学指征的建议。关于接受积极和永久性干预的决定的患者教育，这种干预伴随着显着的发病率和潜在的并发症。在患有散发性乳腺癌的女性中进行CPM的决定使患者对缓解焦虑和不确定性的渴望高于数据表明这些女性确实如此。没有显着的癌症风险健康的乳房以及 CPM 不会带来生存益处的事实在患者面临复杂决策、需要权衡选择的风险和收益的情况下，决策支持辅助工具 (DA) 可以帮助促进明智的选择。为此，我们建议为正在考虑 CPM 的散发性乳腺癌女性开发一个基于理论指导的、基于网络的 CPM-DA，以促进知情决策。我们将分两个阶段来实现这一目标，第一阶段是发展阶段。 DA内容是根据在对接受过治疗或选择不接受 CPM 的女性进行采访后，团队将使用定性方法对这些数据进行分析，收集患者的反馈，并最终确定 CPM-DA 阶段。 2 将是一项针对 80 名考虑 CPM 的女性进行的 CPM-DA 与常规护理的小型随机临床试验，主要目的是评估 CPM-DA 的可行性和可接受性，次要目的是提供有关 CPM-DA 的初步数据。 CPM-DA 的影响准备做出关于 CPM 的决定、CPM 知识、担忧和监测的自我效能、感知的癌症风险、对管理复发的担忧、决策冲突和 CPM 意图。