Outreach and Choice in Colorectal Cancer Screening
试验速览
- 阶段
- 不适用
- 入组人数
- 5,000
- 试验地点
- 2
- 主要终点
- Number of patients with screening completion
研究概览
简要总结
The primary objective of this clinical trial will be to compare overall colorectal cancer (CRC) screening participation between an active choice (fecal immunochemical test [FIT] or colonoscopy) and a sequential choice (FIT offered first, then colonoscoscopy offered in those still unscreened) arm. Secondarily, we will (1) compare the proportions of FIT vs. colonoscopy per arm, (2) compare active choice vs FIT only in the initial 3 months of the study, (3) characterize changes in physician knowledge and attitudes regarding CRC screening before and after an educational seminar delivered at the launch of the initiative, (4) characterize perceptions regarding the effect of the intervention on clinical practices, and (5) compare detection rates of CRC, adenomas and SSLs per arm, and the operational results of the outreach program across arms.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 45 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults 45-75 years of age not up to date with CRC screening, and without precancerous polyp history (i.e. not in post-polypectomy surveillance; ascertained based on problem list or colonoscopy results letter).
- •The assessment of screening status will happen monthly, on a rolling basis.
- •Definition of being up to date with CRC screening includes any one of the following:
- •i) FIT or guaiac-FOBT within 1 year, OR
- •ii) Colonoscopy within 10 years, OR
- •iii) Sigmoidoscopy within 5 years, OR
- •iv) CT colonography within 5 years, OR
- •v) Cologuard within 3 years
排除标准
- •Age outside the 45-75 range.
- •History of precancerous polyps requiring colonoscopy surveillance.
- •Already being up to date with CRC screening, as defined above.
- •Evidence of total removal of the colon which would eliminate the need for screening.
结局指标
主要结局
Number of patients with screening completion
时间窗: 6 months from initial offer
Number of patients with FIT or colonoscopy completed
次要结局
未报告次要终点
研究者
Uri Ladabaum
Professor Medicine
Stanford University