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（由适用提供）：在过去15年中，使用对侧预防性乳房切除术（CPM）在单侧乳腺癌的妇女中被去除了健康的乳房。尽管可以在具有较强乳腺癌家族史的女性中为CPM造成CPM，但不建议使用被诊断出患有流浪性乳腺癌的妇女进行CPM。 CPM的急剧增加是由于选择CPM的刺激性乳腺癌的女性。零星风险的女性选择CPM有很多原因。人们认为，由于技术进步导致乳房重建结果的改善，并且备受瞩目的庆祝活动选择CPM，因此CPM被认为更加可接受。女性选择CPM的主要原因是，乳腺癌会引起乳腺癌是否可能恢复到健康的乳腺或身体另一部分的痛苦和不确定性。这可能会激励患者选择更具侵略性的治疗方法，无论其风险和益处如何。癌症复发的不确定性也可能激励女性选择CPM来减轻这种担忧，即使女性意识到她们在另一个乳房中没有明显的癌症风险，并且CPM不会影响其生存。患者可能不太可能听到外科医生的建议，即CPM没有在医学上表明。临床需要进行更大的患者教育，以决定接受激进和永久的干预措施，该干预措施是通过大量发病率和潜在并发症来实现的。在患有零星乳腺癌的妇女中拥有CPM的决定使患者的渴望缓解焦虑和不确定性以上数据表明，在健康的乳房中，这些妇女没有明显的癌症风险，而CPM没有赋予生存益处的事实。在患者面临需要加重选择的风险和好处的复杂决策的情况下，决策支持艾滋病（DA）可能会有助于促进明智的选择。为此，我们建议为零星乳腺癌的女性开发理论指南，基于网络的CPM-DA，这些女性正在考虑使用CPM来促进知情的决策。我们将分为两个阶段完成此操作。第1阶段是一个发展阶段，基于对经过或选择不具有CPM的妇女的访谈开发DA含量。这些数据将使用定性方法进行分析。接下来，团队将开发CPM-DA，从患者那里收集有关它的反馈，并最终确定CPM-DA。第2阶段将是CPM-DA的一项小型随机临床试验，该试验将其与考虑CPM的80名女性中的常规护理进行了比较。主要目的是评估CPM-DA的可行性和可接受性。第二个目的是提供有关CPM-DA对CPM做出决定，CPM知识，自我效能的准备的初步数据，以管理忧虑和监视，感知到癌症的风险，担心复发，决策冲突，决策冲突和CPM意图。