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临床试验/NCT05321992
NCT05321992招募中不适用

Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand

McMaster University2 个研究点 分布在 1 个国家目标入组 480 人开始时间: 2024年6月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
480
试验地点
2
主要终点
Intake of raw fish

研究概览

简要总结

Liver cancer, specifically cholangiocarcinoma (CCA), is very common in different areas in Thailand. Many factors make this cancer more common, such as liver fluke infection, older age, eating raw fish, family history of cancer, alcohol intake, taking certain medicines (praziquantel), low intake of fresh vegetable, and low education. In 2015, researchers from Khon Kaen University developed the Community-based Health Education and Communication (CHEC) program to prevent liver cancer caused by liver flukes in communities of the Khon Kaen province, Thailand.

The main aim of this 5-year research study is to enhance the CHEC program to prevent liver cancer, and test if it is effective in improving the knowledge and behaviours of community residents regarding how to prevent liver cancer. This study will take place in Khon Kaen, Thailand. Other aims are to:

  1. Increase understanding in the community that make it difficult to prevent liver cancer, as well as community characteristics that can help prevent liver cancer;
  2. Incorporate the program we develop in healthcare to prevent liver cancer in Thailand.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • any individual residing in one of the 16 villages selected in the Khon Kaen province of Thailand, aged 20 and older

排除标准

  • any individual 19 years or younger
  • any individual not residing in one of the 16 pre-selected villages in the Khon Kaen province of Thailand

研究组 & 干预措施

Usual Care Community

No Intervention

Participants in this arm will not be given the eCHEC program

eCHEC Community

Active Comparator

Participants in this arm will be given the eCHEC program as their intervention

干预措施: eCHEC program (Behavioral)

结局指标

主要结局

Intake of raw fish

时间窗: 12 months

Mean difference in the self-reported frequency of intake of raw fish in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Smoking

时间窗: 12 months

Difference in the proportion of smoking habits in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Stages of change for risk behaviours affecting the development of CCA.

时间窗: 12 months

Mean difference in the stages of change for risk behaviours in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Intake of fruits and vegetables

时间窗: 12 months

Mean difference in the self-reported frequency of intake of fruits and vegetables in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Stool test (proportion of stool test concentration)

时间窗: 12 months

Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.

Alcoholic beverage intake

时间窗: 12 months

Mean difference in the intake of alcoholic beverages in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Praziquantel use

时间窗: 12 months

Difference in the proportion of use of the medication praziquantel (prescribed or self-medicated) in the intervention group compared to the control group. Self reported, pre- and post- intervention.

Stool test (mean concentration)

时间窗: 12 months

Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.

次要结局

  • BMI(12 months)
  • Quality of life(12 months)
  • Waist circumference(12 months)
  • Blood pressure(12 months)
  • Health literacy(12 months)
  • Knowledge of preventative measures against CCA(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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