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临床试验/NCT06830304
NCT06830304Enrolling By Invitation不适用

A Multilevel Intervention to Improve Uptake of Gastrointestinal Cancer Screening: a Cluster Randomized Clinical Trial

Chongqing University Cancer Hospital1 个研究点 分布在 1 个国家目标入组 15,000 人开始时间: 2024年4月16日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
Enrolling By Invitation
发起方
入组人数
15,000
试验地点
1
主要终点
Endoscopy Appointment Rate

研究概览

简要总结

This study is a cluster randomized controlled trial aimed at evaluating the effectiveness of a multi-level intervention strategy in improving adherence to gastrointestinal cancer screening. Communities will be randomly assigned as the unit of randomization to either intervention or control group. The study population includes community residents aged 50-74 years. Communities in the intervention group will receive multi-level interventions including health education, patient navigation services, and appointment assistance, while communities in the control group will maintain routine screening management. All participants will be followed up for 90 days to track their endoscopy appointment and completion rates. The main research question is:

Can community-based multi-level intervention effectively improve adherence to gastrointestinal cancer screening among community residents?

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 74 Years(Adult, Older Adult)
性别
All
接受健康志愿者
是

入选标准

  • •high-risk individuals of gastrointestinal cancer in 45-74 years old

排除标准

  • •Unable to give consent
  • •history of cancer
  • •severe cardiac, pulmonary, brain, or renal dysfunction or any other serious disease
  • •psychiatric illness
  • •pregnancy

研究组 & 干预措施

Control Arm

No Intervention

Intervention Group 1

Experimental

Communities assigned to this arm will receive intervention including basic health education.

干预措施: Health education (Behavioral)

Intervention Group2

Experimental

Communities assigned to this arm will receive comprehensive multi-level interventions including health education and patient navigation services....

干预措施: Multi-level Education and Navigation Program for Gastrointestinal Cancer Screening (Behavioral)

结局指标

主要结局

Endoscopy Appointment Rate

时间窗: From enrollment to appointment 90 days

Endoscopy Completion Rate

时间窗: From enrollment to appointment Endoscopy Completion 90 days

Time to Endoscopy Completion

时间窗: Time interval between endoscopy appointment scheduling and completion of colonoscopy.

次要结局

未报告次要终点

研究者

发起方
Chongqing University Cancer Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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