Blood-Based Colorectal Cancer (CRC) Screening Implementation Into Clinical Practice in the Outpatient Clinical Settings in the Appalachian Highlands
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 231
- 试验地点
- 1
- 主要终点
- Opted to be screened for CRC by either SOC or study diagnostic test
研究概览
简要总结
This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
详细描述
Study Rationale This is a prospective implementation study that will include patients that are identified as being average risk for colorectal cancer (CRC) according to USPSTF guidelines and who have opted to be screened for CRC. The purpose of this study is to understand implementation of a noninvasive screening test in primary care and internal medicine clinical settings, and the impact on patient acceptability and adherence of CRC screening.
Although multiple screening options for CRC are available, participation and adherence to CRC screening remains below the national goal. CRC screening rate at the Ballad Health Mountain Laurel Internal Medicine clinic (site 1) is approximately 66%.
A blood-based test (BBT) can provide a clinically important complement to standard-of-care (SOC) screening tests and address unmet medical needs for patients, especially for those who are non-adherent with current screening modalities. There are economic and societal benefits in early detection and prevention of CRC in a broader population than the one currently up to date with screening. The unmet need for maximum participation in CRC screening could be addressed with blood-based testing.
Measuring subsequent provider experience and implementation behavior patterns involving blood based non-invasive cancer screening choices will also help to identify clinical utility of such test and implementation into clinical practice.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 84 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 45-84 years of age (inclusive)
- •Considered by health-care providers to be "average risk" for CRC as determined by USPSTF guidelines
- •If a patient opts for blood-based test, they are able and willing to provide blood samples per protocol
- •Ability to understand and the willingness to participate in the study
排除标准
- •Patients with a personal history of CRC
- •Patients with a known high-risk family history of CRC precluding the patient from being average risk
- •Patients with known diagnosis of inflammatory bowel disease or history of polyps
- •Patients who are currently symptomatic for CRC such as: blood in the stool
- •Patients with any known medical condition which, in the opinion of the investigator, should preclude enrollment into the study
- •Have a recorded up to date CRC screening
- •Patients with a previous abnormal colonoscopy finding who are due for surveillance.
研究组 & 干预措施
Screening Discussion and Election
Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options. Patients who express a desire to be screened using the SOC options will be considered part of the control group.
Screening Selection
Patients judged to be at average risk of CRC will be engaged in a conversation about CRC risk factors and standard of care (SOC) screening options as well as the option to be screened with a blood-based test which is not currently standard of care. Patients who express a desire to be screened using the SOC options or the blood-based non-SOC option will be considered part of the experimental group.
干预措施: blood-based CRC screening (Diagnostic Test)
结局指标
主要结局
Opted to be screened for CRC by either SOC or study diagnostic test
时间窗: 3 months
Number of participants who agree to be screened CRC. % of participants who agree to be screened for CRC.
次要结局
- Opted to be screened by the study diagnostic test(3 months)