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危女性她们患乳腺癌(BC)的风险，以帮助她们做出关于他莫昔芬()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，来对高危患者进行风险分层，并更准确地定义个体风险，是非常有希望的方法。为此，随机乳晕细针抽吸(RPFNA)作为一种预测个体BC风险的研究工具显示出很大的前景。对于知情决定的过程，妇女必须了解RPFNA结果的含义，以及它如何适用于根据其他风险因素重新评估对BC的看法，以及随后关于使用的决定。影响上述过程的两个关键因素可能是患者的健康素养和算力水平。基于这一理论，这项拟议的研究将率先解决：1)患者如何真实地理解RPFNA结果并从中得出情感(即，情绪)意义；2)这种理解如何影响对BC风险和担忧的感知，以及随后涉及的决策过程；以及3)算术和健康素养如何影响对BC风险的理解，从而影响对BC风险的感知，以及涉及的决策过程。为了实现这些目标，杜克大学医学中心预防诊所的大约120名选择接受RPFNA且有五年BC风险的女性将完成一项基线调查，评估内容包括：(1)对BC风险和担忧的认知，(2)对风险和益处的了解和认知，对其使用的兴趣，以及算术和健康素养。然后，妇女将接受RPFNA，并返回进行第二次诊所访问，以讨论结果。咨询结束后，我们将评估对结果的理解，并重新评估对BC风险和担忧、的风险和收益以及使用决定的看法。研究结果有助于理解RPFNA和生物标记物如何更广泛地有效地整合到临床实践中，以影响对BC风险的感知和关于BC预防策略的决策。这将是第一项在临床实践中探索乳腺癌风险认知、随机周围细针抽吸(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；这项研究处于了解在临床实践中使用RPFNA作为交流生物标记物的模型的可能优势和劣势的最前沿，这可能推广到其他提供生物标记物信息的方法的使用。这些发现有助于未来的干预措施，利用生物标记物和涉及乳腺癌风险较高女性的临床护理管理的决定，改善对乳腺癌风险的有效沟通和了解。

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.