Multicenter trial of decision support for breast cancer chemoprevention

乳腺癌化学预防决策支持的多中心试验

• 批准号: 9901126
• 负责人: Katherine D Crew
• 金额: $ 2.63万
• 依托单位: COLUMBIA UNIVERSITY HEALTH SCIENCES
• 依托单位国家: 美国
• 财政年份: 2019
• 资助国家: 美国
• 起止时间: 2019-08-01 至 2023-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9901126
• 关键词: Acculturation; Adherence; Adoption; Affect; Aromatase Inhibitors; Atypical hyperplasia; Benign; Breast Cancer Risk Factor; Characteristics; Chemoprevention; Chemopreventive Agent; Clinic; Clinic Visits; Clinical Trials; Cluster randomized trial; Community Clinical Oncology Program; Community Networks; Conflict (Psychology); Counseling; Decision Aid; Educational Materials; Effectiveness; Electronic Health Record; Enrollment; Evaluation; Exposure to; Future; Health Personnel; High Risk Woman; Hybrids; Incidence; Infrastructure; Institution; Intervention; Interview; Knowledge; Maintenance; Malignant Neoplasms; Mammographic screening; Methods; Multicenter Trials; Online Systems; Outcome; Patients; Phase; Primary Prevention; Provider; Questionnaires; Randomized; Randomized Controlled Trials; Readiness; Relative Risks; Research; Risk Reduction; Sampling; Selective Estrogen Receptor Modulators; Site; Specialist; Structure; Surveys; Target Populations; Testing; Time; Woman; academic standard; base; breast lesion; cancer chemoprevention; care providers; design; follow-up; health literacy; high risk; high risk population; improved; informant; lobular breast carcinoma in situ; malignant breast neoplasm; mathematical ability; patient oriented; patient portal; practice setting; primary care setting; programs; risk perception; shared decision making; side effect; study population; support tools; theories; tool; treatment arm; underserved minority; uptake

Breast cancer chemoprevention with selective estrogen receptor modulators (SERMs) and aromatase inhibitors (AIs) is underutilized, despite several randomized controlled trials demonstrating a 50-65% decrease in breast cancer incidence among high-risk women. Women with atypical hyperplasia (AH) or lobular carcinoma in situ (LCIS) have a 4- to 10-fold increased risk of breast cancer and derive up to a 70-80% relative risk reduction with SERMs or AIs. Reasons for low chemoprevention uptake include inadequate time for counseling, insufficient knowledge about SERMs and AIs, and concerns about side effects. We hypothesize that standard educational materials combined with decision support tools will increase chemoprevention informed choice compared to standard educational materials alone among women with AH or LCIS. We have developed web-based decision support tools, RealRisks for high-risk women and BNAV (Breast cancer risk NAVigation tool) for healthcare providers. Our patient-centered decision aid, RealRisks, is available in English and Spanish and has been rigorously tested in multi-ethnic high-risk women of varying health literacy, numeracy, and acculturation. After exposure to these tools, we have demonstrated an improvement in accurate breast cancer risk perceptions, chemoprevention knowledge and informed choice among multi-ethnic high-risk women. Our objective is to integrate these tools into clinic workflow via the electronic health record (EHR) and expand their use in a multicenter trial targeting women with AH or LCIS. To evaluate effectiveness (Aim 1) and implementation (Aim 2), we will conduct a hybrid cluster-randomized trial at 40 sites of standard educational materials combined with RealRisks and BNAV or standard educational materials alone among 384 women with AH or LCIS. We will leverage the clinical trials infrastructure of the NCI Community Oncology Research Program (NCORP), including minority/underserved sites. Our primary effectiveness endpoint is chemoprevention informed choice at 6 months after enrollment (Aim 1). Secondarily, we will assess chemoprevention knowledge, perceived breast cancer risk/worry, and decision conflict at baseline, 6 and 12 months, as well as shared decision-making and chemoprevention uptake/adherence. For the implementation component of the trial (Aim 2), we will evaluate the impact of portal integration of the decision support tools using surveys and key informant interviews of healthcare providers, including specialists and primary care providers, and high-risk women with AH or LCIS to better understand barriers and facilitators to chemoprevention uptake. We will use the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework for the implementation evaluation. This proposal seeks to overcome important barriers to chemoprevention uptake among diverse women with AH or LCIS, a population of high-risk women that is more likely to benefit from SERMs and AIs. Providing EHR- integrated decision support for patients and providers has the potential to improve informed shared decision- making about breast cancer chemoprevention, which is sustainable and may be widely disseminated.

乳腺癌化学预防与选择性雌激素受体调节剂（SERM）和芳香酶 抑制剂（AIS）未充分利用，尽管有几次随机对照试验表明降低了50-65％ 高危女性的乳腺癌发病率。具有非典型增生（AH）或小叶癌的女性 原位（LCIS）的乳腺癌风险增加了4至10倍，并且相对风险降低高达70-80％ 与Serms或AIS。化学预防吸收低的原因包括咨询时间不足，不足 有关SERMS和AIS的知识，以及对副作用的关注。我们假设该标准教育 与决策支持工具相结合的材料将增加化学预防知识的选择 AH或LCI的女性中仅提供标准教育材料。 我们已经开发了基于Web的决策支持工具，高风险女性和BNAV的Realrisks（乳房 癌症风险导航工具）医疗保健提供者。我们以患者为中心的决策援助可用 在英语和西班牙 算术和适应。接触这些工具后，我们证明了准确的改进 乳腺癌风险感知，化学预防知识和多种族高风险的知情选择 女性。我们的目标是通过电子健康记录（EHR）和 扩大针对AH或LCI的女性的多中心试验中的使用。评估有效性（目标1）和 实施（AIM 2），我们将在标准教育的40个地点进行混合群集随机试验 仅在384名妇女中，材料与Leanrisks和BNAV或标准教育材料相结合 啊或lcis。我们将利用NCI社区肿瘤研究计划的临床试验基础设施 （NCORP），包括少数族裔/服务不足的地点。我们的主要有效性终点是化学预防 入学后6个月的知情选择（AIM 1）。其次，我们将评估化学预防知识， 乳腺癌的风险/忧虑和基线，6个月和12个月的决策冲突以及共享 决策和化学预防的吸收/依从性。对于试验的实施部分（目标 2），我们将使用调查和关键线人评估决策支持工具的门户集成的影响 医疗保健提供者的访谈，包括专家和初级保健提供者，以及高危妇女 AH或LCI可以更好地了解化学预防吸收的障碍和促进因子。我们将使用re-aim （覆盖，有效性，采用，实施，维护）实施评估的框架。 该提议旨在克服与患有化学预防吸收的重要障碍 AH或LCI，是一群高风险女性，更有可能从SERMS和AI中受益。提供EHR- 对患者和提供者的综合决策支持有可能改善知情的共同决策 - 关于乳腺癌化学预防，这是可持续的，可能会被广泛传播。