社区服务导航促进乳腺癌筛查健康公平 (B-SINCERE)
2025年7月29日 更新者：University of Utah
本研究的目的是评估将社区服务导航添加到满足社会需求的标准转诊流程中是否是解决异常乳腺癌筛查结果随访差异的有效且可扩展的策略。
研究人员将确定社会需求转介与筛查乳房X光检查环境中的社区服务导航干预相结合的有效性，以改善服务不足的女性的乳房筛查结果。
研究概览
详细说明
乳腺癌预后的差异是持续存在的。 在美国，乳腺癌是女性中最常见，第二大致命的癌症，估计有281,550个新的侵入性乳腺癌诊断，而2021年有43,600例乳腺癌死亡。 服务不足的妇女，那些无法获得足够的医疗服务的妇女在这些死亡中的代表不成比例，发病率较低，但死亡率较高。 自1990年以来，美国乳腺癌的死亡率每年降低了约2％，但在这段时间内，社会和经济上处于劣势的妇女的乳腺癌死亡率增加了。 农村妇女更有可能经历诊断延迟，与城市妇女相比，被诊断出患有晚期疾病的可能性高出1.5倍。
利用现有的社会系统进行社区导航，以促进乳房筛查的随访。 我们的研究表明，使用现有的，低成本的软件解决方案可以适应临床工作流程，可以使用临床环境中的社会需求筛查与United Way 211的社区推荐服务之间的联系。 具体而言，真诚的10项社会需求筛选员与社区服务导航相结合，并在随机对照试验中进行了测试。 该试验表明，这种低成本（广泛可用的解决方案）的功效可以解决脆弱和服务不足的患者的需求；也就是说，211活跃的外展诉被动信息以满足所报告的社会需求。 但是，该试验是在急诊室进行的，尚未在其他临床环境中进行测试。 在乳腺癌筛查（集体）数十年的工作中，多个PI组成了一个跨学科团队，该团队在乳房X线照相诊所试行了对真诚的社会服务筛查者（称为“ B-Sincere”）的改编。 这项研究将测试B-Sincere社区导航干预措施的实际功效（NIH阶段3），以增加乳腺癌筛查发作的完成。 如果有效，则该干预措施将通过全州社区服务提供商和现有健康信息技术进行扩展。 因此，对早期检测产生真正影响并改善乳腺X线照片异常妇女的乳腺癌结局的承诺是这项工作的总体驱动力
研究类型
介入性
注册 (估计的)
1450
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Elissa Ozanne, PhD
- 电话号码：801-213-4130
- 邮箱：Elissa.Ozanne@hsc.utah.edu
学习地点
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Utah
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Salt Lake City、Utah、美国、84112
- 招聘中
- University of Utah Health Hospitals/Huntsman Cancer Institute Population Sciences
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接触：
- Elissa Ozanne, PhD
- 电话号码：801-213-4130
- 邮箱：Elissa.Ozanne@hsc.utah.edu
-
副研究员：
- Tracy Onega, PhD
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 讲英语和西班牙语的人
- 收到乳房 X 光检查筛查结果异常
- 在 B-SINCERE Screener 上自我报告至少一项社交需求
排除标准：
- 乳腺癌的既往诊断
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：卫生服务研究
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
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有源比较器：通常的护理
标准推荐对社区资源将用于随机分配给常规护理的参与者。
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标准转介社区资源。
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实验性的：干涉
与211位信息专家（ISS）的社区服务导航将在通过电话，文本或电子邮件推荐后48小时内对参与者进行宣传，具体取决于患者的喜好。
初次联系后两周与患者进行跟进，以提供服务点中推荐服务的额外支持和文档使用。
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随机接受干预的患者将被直接转介至盐湖城 United Way 的 211 社区转诊服务以获得额外的服务。
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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改变社会需求
大体时间：基线评估后长达18个月
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参与者的社会需求水平的变化是由B-Sincere（用于加强社区转介健康的乳房筛选器）筛选器衡量的。
为了测试与单独推荐（通常的护理）相比，与社会服务转介结合使用社区服务导航干预措施是否会降低社会需求。
b-sincere报道，以0-10的比例报告，0 =不存在社会需求，而有1-10 =存在的社会需求，大于0的事物表示社会需求和研究资格。
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基线评估后长达18个月
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情节完成（EC）。
大体时间：基线评估后长达18个月
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EC是二分法的名称，以2分制报告，该量表是根据患者电子健康记录（EHR）计算得出的，0 =没有完成乳腺癌筛查，1 =完成乳腺癌筛查。 社区服务导航干预对具有自我报告的社会需求的妇女的乳腺癌筛查事件完成和预防性护理利用的影响。 预防性护理利用是一种描述性措施，没有按比例报告得分。 |
基线评估后长达18个月
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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区域剥夺指数（ADI）
大体时间：基线评估后长达18个月
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DI是评估该地区社会经济条件的工具。
分数范围为1-100，得分较低，表明社会经济劣势最少，得分较高，表明更多的社会经济劣势。
这项结果措施将在基线之后在农村参与者（基于邮政编码）的6个月和18个月的城市参与者（基于邮政编码）报告ADI。
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基线评估后长达18个月
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农村城市通勤区（RUCA）
大体时间：基线评估后长达18个月
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RUCA评估城市化，人口密度和通勤。
分数从1到10，得分较低，表明更多的城市地区和更高的分数代表了更多的农村地区。
这项结果措施将在基线之后在农村与城市参与者（基于邮政编码）的6个月和18个月的城市参与者（基于邮政编码）报告RUCA。
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基线评估后长达18个月
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社会服务利用
大体时间：基线评估后长达18个月
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社会服务利用率将评估有多少研究参与者利用211个社会服务。
该结果措施将报告利用以下211医疗服务的参与者的比例：寻找健康食品，成人教育/职业培训/就业，服装/用品，住房，交通，支付医疗保健，支付账单，托儿服务，其他，其他211，211没有帮助我获得任何服务。
该结果措施将在基线评估后1、6和18个月报告社会服务利用率。
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基线评估后长达18个月
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乳腺癌风险（Tyrer-Cuzick）
大体时间：基线评估后长达18个月
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Tyrer-Cuzick乳腺癌风险评分估计乳腺癌的可能性。
分数从0到100，得分较低，表明乳腺癌的风险低，得分高表明乳腺癌的风险很高。
该结果度量将报告基线评估后6和18个月的平均乳腺癌风险评分。
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基线评估后长达18个月
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一般健康状况
大体时间：基线评估后长达18个月
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一般健康状况是评估一般健康的规模。
分数从0到5，得分较低，表明健康状况更好，得分更高，表明健康状况较差。
该结果措施将在基线评估后1、6和18个月报告一般健康状况。
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基线评估后长达18个月
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自我报告产生的查尔森合并症指数
大体时间：基线评估后长达18个月
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查尔森合并症指数是一个基于合并症的死亡率风险的得分。 分数范围从1到37，得分较低，表明死亡率更高，而得分更高，代表死亡率较差。 该结果措施将在基线评估后6和18个月报告平均Charlson合并症指数。 |
基线评估后长达18个月
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预防服务访问
大体时间：从基线评估到18个月
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预防服务访问将衡量有多少参与者完成预防访问。
该结果措施将报告完成预防性就诊的参与者的比例，例如下一次年度乳房X光检查，宫颈癌筛查或结直肠癌筛查。
该结果措施将报告在基线评估后1、6和18个月完成预防服务访问的比例。
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从基线评估到18个月
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Promis全球健康
大体时间：基线评估后长达18个月
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Promis Global Health是评估参与者健康的问卷。
分数从0到32，得分较低，表明健康状况较差，得分较高，表明健康状况更好。
该结果措施将在基线评估后1、6和18个月报告Promis全球健康。
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基线评估后长达18个月
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Promis抑郁症
大体时间：基线评估后长达18个月
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Promis抑郁症是评估参与者心理健康的问卷。
分数从0到32，得分较低，表明心理健康和更高的分数表明心理健康状况较差。
该结果措施将在基线评估后1、6和18个月报告Promis抑郁症。
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基线评估后长达18个月
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医疗保健通道
大体时间：基线评估后长达18个月
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医疗保健访问是评估患者获得医疗保健的四项问卷。
分数范围为0-12，得分较低，表明获得医疗保健的机会较差，得分较高，表明获得医疗保健的机会更好。
该结果措施将在基线评估后6和18个月报告医疗保健访问。
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基线评估后长达18个月
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elissa Ozanne, PhD、Huntsman Cancer Institute
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
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研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年4月30日
初级完成 (估计的)
2028年9月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2024年2月29日
首先提交符合 QC 标准的
2024年3月8日
首次发布 (实际的)
2024年3月12日
研究记录更新
最后更新发布 (实际的)
2025年8月1日
上次提交的符合 QC 标准的更新
2025年7月29日
最后验证
2025年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.