NCT02929186已完成不适用
Opt-In Versus Opt-Out for Colorectal Cancer Screening Outreach
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 314
- 主要终点
- FIT Completion Rate
研究概览
简要总结
This is a randomized controlled pilot study aimed at testing different outreach strategies (opt-in versus opt-out) to increase colorectal cancer screening through completion of mailed home fecal immunohistochemical testing (FIT).
详细描述
This is a randomized controlled pilot study aimed at testing different outreach strategies to increase colorectal cancer screening using mailed fecal immunohistochemical testing (FIT). The investigators will randomize a cohort of subjects between the ages of 50-74 into 2 arms:
- Opt-In - subject must actively choose to receive a home FIT kit.
- Opt-Out - a FIT kit is sent as a default unless the subject actives chooses not to receive the kit or reports prior screening.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Screening
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 50 Years 至 74 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 50 to 74 years old
- •Has received care at the Division of Internal Medicine
- •Due for screening
- •Asymptomatic for colorectal cancer (CRC)
排除标准
- •Has had prior colonoscopy within 10 years, sigmoidoscopy within 5 years, and fecal occult blood test (FOBT)/FIT within twelve months of the chart review (We will exclude patients who self-report undergoing any of the above procedures)
- •Has a history of CRC
- •Has a history of other GI cancer
- •Has history of confirmed Inflammatory Bowel Disease (IBD) (e.g. Crohn's disease, ulcerative colitis; Irritable bowel syndrome does not exclude patients)
- •Has history of colitis other than Crohn's disease or ulcerative colitis
- •Has had a colectomy
- •Has a relative that has been diagnosed with CRC
- •Has been diagnosed with Lynch Syndrome (i.e. HNPCC)
- •Has been diagnosed with Familial Adenomatous Polyposis (FAP)
- •Has iron deficiency anemia
- •Has history of lower GI bleeding
- •Has metastatic (Stage IV) blood or solid tumor cancer
- •Has end stage renal disease
- •Has cirrhosis
- •Has heart failure
- •Has dementia
- •Has any other condition that, in the opinion of the investigator, excludes the patient from participating in this study
结局指标
主要结局
FIT Completion Rate
时间窗: 3 months
The percentage of participants who successfully complete the FIT.
次要结局
- Mail/Electronic Message Engagement(3 months)
研究者
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