Facilitating Web-based Patient Decision Support for Hereditary Breast Cancer Risk

描述（由申请人提供）：对于乳腺癌高风险的女性来说，帮助她们现实地评估自己的决策需求和获得高质量的决策支持资源是很重要的，这样她们就可以在化学预防方面做出明智的、价值敏感的决策。这提供了一个及时的临床和公共卫生机会，使妇女了解其乳腺癌风险决定，并通过创新的基于网络的决策支持干预来支持其决策需求，以补充在决策期间随时随地和经常需要的临床护理。拟议的项目将总体上以认知-社会健康信息处理模式为指导，并将渥太华决策支持框架纳入一个一致的决策支持进程。具体目标是：(1)目标1：开发和完善基于网络的患者决策支持模块，用于高风险女性对乳腺癌化学预防做出决定，作为设计更全面的癌症健康决策可信顾问（TACHD）决策支持系统的原型；(2)目标2：对化学预防模块的影响进行形成性评估，其中将包括一项试点研究和过程评估。对于目标1，TACHD的开发将遵循三个阶段，这将导致：(1)功能性HTML屏幕；(2)功能齐全的干预网站；(3)具有管理功能。他们将与目标人群进行用户测试和可用性测试。在目标2中，化学预防决策支持模块的试点测试将在两组测试前和测试后的实验设计中进行，通过Fox Chase风险评估项目和国家海军医学中心的NCI临床癌症遗传学项目确定64名高危女性。过程评价分析将使用TACHD评估参与者的体验。在目的2分析中，(1)双侧双样本配对t检验将评估TACHD对决策冲突主要结局、决策阶段、注意风格、癌症担忧、癌症困扰和癌症风险感知变化的影响；(2)双样本配对t检验将识别与决策冲突差异变化相关的离散版本的心理因素；(3)探讨潜在的调节变量（注意风格）和调节变量（癌症担忧、癌症困扰、癌症风险感知）。诸如TACHD之类的决策支持干预措施可以在关注乳腺癌风险的个人中促进高质量决策（定义为知情和符合个人价值观），并带来更好的公共卫生结果，例如改善减少风险的行为，降低癌症相关的发病率和死亡率。

DESCRIPTION (provided by applicant): For women at high risk of breast cancer, it is important to help them realistically assess their decision making needs and access quality decision support resources so they can make informed, value-sensitive decisions about chemoprevention. This presents a timely clinical and public health opportunity to inform women about their breast cancer risk decisions and support their decision-making needs through an innovative web-based decision support intervention to complement clinical care, that is available whenever, wherever, and as often as needed during the decision-making period. The proposed project will be guided by the Cognitive-Social Health Information Processing model overall, and incorporate the Ottawa Decision Support Framework in one consistent decision support process. Specific aims are to: (1) Aim 1: Develop and refine a web-based patient decision support module for high-risk women making a decision about breast cancer chemoprevention, to be used as a prototype for designing a more comprehensive Trusted Advisor for Cancer Health Decisions (TACHD) decision support system, and (2) Aim 2: Conduct a formative evaluation of the impact of the chemoprevention module, which will include a pilot study and a process evaluation. For Aim 1, TACHD development will follow three phases that will result in: (1) functional HTML screens; (2) a fully functional intervention web site; and (3) an administrative functionality. They will be user- tested and usability tested with the target population. For Aim 2, pilot testing of the chemoprevention decision support module will be conducted in a two-group pre- post-test experimental design with 64 at-risk women identified through Fox Chase Risk Assessment Programs and the NCI Clinical Cancer Genetics Program at National Naval Medical Center. A process evaluation analysis will assess participants' experiences using TACHD. For aim 2 analyses, (1) two-sided two-sample paired t-tests will evaluate the impact of TACHD on changes in the primary outcome of decisional conflict, as well as decision stage, attentional style, cancer worry, cancer distress, and cancer risk perception; (2) two-sample, paired t-tests will identify discrete versions of psychological factors associated with differential changes in decisional conflict; and (3) potential moderator (attentional style) and mediator variables (cancer worry, cancer distress, cancer risk perception) will be explored. Decision support interventions such as TACHD can promote quality decisions -- defined as informed and consistent with personal values -- among individuals concerned about breast cancer risk and result in better public health outcomes such as improved risk reduction behaviors and lower cancer-related morbidity and mortality.