Improving Colon Cancer Screening for Diverse Populations
2016年9月1日 更新者：University of North Carolina, Chapel Hill
The CHOICES/OPCIONES Project: Improving Colon Cancer Screening for Diverse Populations
This study is a multi-site randomized, controlled trial testing the effect of a combined intervention that includes a colorectal cancer (CRC) screening decision aid plus patient navigation in a diverse, primary care patient population in clinical sites in North Carolina and New Mexico.
Our primary aim is to determine the effect of the intervention on CRC screening completion six months after the index visit among all enrolled participants and among Latinos. Secondarily, we will determine how this intervention affects screening-related knowledge, self-efficacy, intent, and clinical communication, and examine whether these factors mediate the effect of the intervention on screening test completion. Lastly, we will explore whether insurance status, ethnicity, and patient language preference moderate the effect of the intervention on screening.
研究概览
研究类型
介入性
注册 (实际的)
265
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。
学习地点
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New Mexico
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Albuquerque、New Mexico、美国、87131
- University of New Mexico
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North Carolina
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Chapel Hill、North Carolina、美国、27599
- University of North Carolina
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Charlotte、North Carolina、美国、28203
- Carolinas HealthCare Systems
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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
50年 至 75年 (成人、年长者)
接受健康志愿者
是的
有资格学习的性别
全部
描述
Inclusion Criteria:
- Patients 50 to 75 years old who are not current with colorectal cancer (CRC) screening, defined as not having completed a home fecal occult blood test (FOBT) within the past year; a flexible sigmoidoscopy within the past five years; or a colonoscopy within the past ten years.
- Have an appointment at one of the clinic sites
Exclusion Criteria:
- Will include: inability to speak either English or Spanish, severe illness at the time of the clinic visit, co-morbidity that is estimated to limit life-expectancy to less than 5 years as estimated by the treating nurse or provider, severe cognitive, visual, or hearing impairment that would preclude Decision Aid (DA) viewing. We will also exclude patients who are at elevated risk for CRC, defined as having ever been diagnosed with CRC, a precancerous (adenomatous) polyp, or inflammatory bowel disease.
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：放映
- 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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无干预：控制组
平时护理。
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实验性的：Intervention group
Decision aid and navigation
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Patients in the intervention group will receive a combined intervention consisting of a CRC screening decision aid and assistance from a trained patient navigator.
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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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Colorectal cancer screening completion
大体时间：6 months
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A blinded medical record review will be used to determine the primary outcome of 6 month Colorectal cancer screening status.
To ensure optimal capturing of screening test completion, we will ask participants whose medical record does not contain evidence of screening to verify non-completion during the 6 month phone survey.
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6 months
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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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Colorectal cancer screening knowledge
大体时间：Post-encounter measure
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Following the provider encounter, we will administer the post-encounter survey to measure intermediate screening related knowledge.
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Post-encounter measure
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Colorectal cancer screening related self-efficacy
大体时间：6 months
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The Colorectal cancer screening self-efficacy will be measured by the post-encounter survey.
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6 months
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Colorectal cancer screening related intent
大体时间：6 months
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The post-encounter survey will be used to measure the Colorectal cancer screening related intent.
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6 months
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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：Daniel Reuland, MD, MPH、University of North Carolina
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。
一般刊物
- Reuland DS, Brenner AT, Hoffman R, McWilliams A, Rhyne RL, Getrich C, Tapp H, Weaver MA, Callan D, Cubillos L, Urquieta de Hernandez B, Pignone MP. Effect of Combined Patient Decision Aid and Patient Navigation vs Usual Care for Colorectal Cancer Screening in a Vulnerable Patient Population: A Randomized Clinical Trial. JAMA Intern Med. 2017 Jul 1;177(7):967-974. doi: 10.1001/jamainternmed.2017.1294. Erratum In: JAMA Intern Med. 2017 Jul 1;177(7):1062.
- Brenner AT, Hoffman R, McWilliams A, Pignone MP, Rhyne RL, Tapp H, Weaver MA, Callan D, de Hernandez BU, Harbi K, Reuland DS. Colorectal Cancer Screening in Vulnerable Patients: Promoting Informed and Shared Decisions. Am J Prev Med. 2016 Oct;51(4):454-62. doi: 10.1016/j.amepre.2016.03.025. Epub 2016 May 27.
- Brenner AT, Getrich CM, Pignone M, Rhyne RL, Hoffman RM, McWilliams A, de Hernandez BU, Weaver MA, Tapp H, Harbi K, Reuland D. Comparing the effect of a decision aid plus patient navigation with usual care on colorectal cancer screening completion in vulnerable populations: study protocol for a randomized controlled trial. Trials. 2014 Jul 8;15:275. doi: 10.1186/1745-6215-15-275.
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
2014年1月1日
初级完成 (实际的)
2016年3月1日
研究完成 (实际的)
2016年3月1日
研究注册日期
首次提交
2014年1月31日
首先提交符合 QC 标准的
2014年1月31日
首次发布 (估计)
2014年2月4日
研究记录更新
最后更新发布 (估计)
2016年9月2日
上次提交的符合 QC 标准的更新
2016年9月1日
最后验证
2016年9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.