跳至主要内容
临床试验/NCT05646355
NCT05646355已完成不适用

Colorectal Cancer Screening Through Proactive Outreach and Navigation in a Federally Qualified Health Care Center in Brooklyn

NYU Langone Health2 个研究点 分布在 1 个国家目标入组 109 人开始时间: 2023年3月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
109
试验地点
2
主要终点
Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months

研究概览

简要总结

The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice.

详细描述

The proposed study is a randomized controlled pilot trial designed to assess the effectiveness and acceptability of a proactive screening outreach program on colorectal cancer screening rates on eligible patients in the Flatbush Family Health Center medical practice, which provides free and subsidized health services to underrepresented minorities. The investigators will randomize patients to the proactive screening outreach arm which will include mailed letters providing patients with information regarding their eligibility for and instructions for performing colorectal cancer screening with FIT testing or colonoscopy. Colorectal cancer screening rates via FIT testing or colonoscopy will be compared in the proactive outreach group and the usual care group. The investigators hypothesize that rates of colorectal cancer screening will improve in underserved populations with the implementation of a proactive approach that incorporates a mailed outreach invitation to screen, followed by active assistance to a colonoscopy completion if preferred or indicated.

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
None

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

入选标准

  • Receiving medical care at Flatbush FHC
  • Due or overdue for CRC screening

排除标准

  • Age younger than 45 years old or greater than 75 years old
  • Up-to-date with colorectal cancer screening (FIT within 1 year or colonoscopy within 10 years)
  • History of colorectal cancer, inflammatory bowel disease or colorectal polyps
  • No address or phone number on file
  • FIT test ordered within 6 months

结局指标

主要结局

Number of Participants Who Complete Initial Fecal Immunochemical Test (FIT) at 6 Months

时间窗: Up to Month 6

Number of Participants who completed CRC screening via FIT by 6 months past the start of intervention

Number of Participants Who Completed Colonoscopy at 6 Months

时间窗: Up to Month 6

Number of Participants who underwent colonoscopy by 6 months past the start of intervention

次要结局

  • Number of Participants With Positive FIT Test Who Complete Colonoscopy at 6 Months(Up to Month 6)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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