Effects of Communicating RPFNA Results on Decisions about Tamoxifen Use

描述（由申请人提供）：我们如何最好地告知高风险女性她们的乳腺癌（BC）风险，以帮助她们做出关于他莫昔芬（Tam）用于BC化学预防的明智决定？为了解决这个问题，使用生物标记物（如异型性）对高风险患者进行风险分层并更精确地定义个体风险的方法非常有希望。为此，随机乳晕周围细针抽吸（RPFNA）作为预测个体BC风险的研究工具显示出很大的希望。对于知情决策的过程，妇女必须了解RPFNA结果的含义，以及它如何应用于根据其他风险因素对BC的看法的重新评估，以及随后使用Tam的决定。影响上述进程的两个关键因素是患者的卫生知识水平和计算能力。基于这一基本原理，拟议的研究将是第一个解决：1)患者如何从RPFNA结果中实际理解和获得情感（即情感）意义；2)以及这些理解如何影响对BC风险和担忧的认知，以及随后涉及Tam的决策过程；3)计算能力和健康素养如何影响理解，从而影响对BC风险的认知，以及涉及Tam的决策过程。为了实现这些目标，约120名在杜克大学医学中心预防诊所接受RPFNA治疗且5年BC风险为bb1.66%的女性将完成一项基线调查，评估：(1)对BC风险和担忧的认知，(2)对Tam风险和益处的了解和认知，以及对其使用的兴趣，以及计算和健康素养。然后，妇女将接受RPFNA检查，并返回第二次诊所讨论结果。在咨询之后，我们将评估对结果的理解，并重新评估对BC风险和担忧的看法，Tam的风险和收益以及使用的决定。研究结果有助于理解RPFNA和生物标志物如何更普遍地融入临床实践，有效地影响对BC风险的认知和BC预防策略的决策。这将是第一个在实际临床实践中探索乳腺癌风险认知、随机乳泡周围细针抽吸（RPFNA）结果和他莫昔芬之间的相互关系如何影响乳腺癌预防决策的研究；这项研究是了解在临床实践中使用RPFNA作为交流生物标志物的模型可能存在的优势和劣势的最前沿，这可能推广到使用其他提供生物标志物信息的方法。研究结果有助于未来的干预措施，以提高对乳腺癌风险的有效沟通和理解，利用生物标志物和涉及乳腺癌高风险妇女临床护理管理的决策。

DESCRIPTION (provided by applicant): How do we best inform higher risk women of their breast cancer (BC) risk to assist them in making informed decisions about tamoxifen (Tam) for BC chemoprevention? To address this question, methods that use biomarkers, such as atypia, to risk-stratify high- risk patients and more precisely define individual risk is very promising. To this end, Random Periareolar Fine Needle Aspiration (RPFNA) shows much promise as a research tool predicting individual BC risk. For processes of informed decisions, women must have an understanding of what the RPFNA result means and how it applies to the reevaluation of perceptions of BC in light of other risk factors, and subsequent decisions about using Tam. Two factors that may be critical to affecting the above processes are patients' levels of health literacy and numeracy. Based on this rationale, the proposed study will be the first to address: 1) how patients factually understand and derive affective (i.e, emotional) meaning from the RPFNA result; 2) and how such understandings affect perceptions of BC risks and worry, and subsequent decision-making processes involving Tam; and 3) how numeracy and health literacy affect understanding, and as a result, perceptions of BC risk, and decision- making processes involving Tam. To address these goals, about 120 women attending the Prevention Clinic at Duke University Medical Center who elect to have RPFNA and have a five-year BC risk of > 1.66% will complete a baseline survey that assesses: (1) perceptions of BC risk and worry, (2) knowledge of and perceptions of Tam's risks and benefits and interest in its use as well as numeracy and health literacy. Women will then undergo RPFNA and return for a second clinic visit to discuss the result. Following the consultation, we will assess understanding of the result and reassess perceptions of BC risk and worry, Tam's risk and benefits and decision to use. Study results are relevant for understanding how RPFNA and biomarkers more generally can be integrated into clinical practice effectively to affect perceptions of BC risk and decision making about BC prevention strategies. This will be the first study to explore in actual clinical practice how the inter- relationships between breast cancer risk perceptions, Random Periareolar Fine Needle Aspiration (RPFNA) results, and Tamoxifen are understood to affect decisions about breast cancer prevention; this study is at the very forefront of learning about the possible strengths and weaknesses of using RPFNA as a model of communicating biomarkers in clinical practice that may generalize to the use of other methods of providing biomarker information. Findings can contribute to future interventions to improve the effective communication and understanding of breast cancer risk using biomarkers and decisions involving the clinical management of care among women at higher breast cancer risk.