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

Cholangiocarcinoma Clinical Trial

— eCHEC  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05321992
• Other study ID #: 0609004105
• Secondary ID: 13955
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: April 1, 2026

Study information

• Verified date: March 2024
• Source: McMaster University
• Contact: Ricardo Angeles, MD, MPH, MHPEd, PhD
• Phone: 905-515-2100
• Email: angelesric[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 480
• Est. completion date: April 1, 2026
• Est. primary completion date: April 1, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Cholangiocarcinoma

Intervention

Behavioral:
• eCHEC program
The eCHEC program is the enhanced Community-based Health Education and Communication (CHEC) model to prevent O. viverrini in an effort to decrease cholangiocarcinoma (CCA) in Khon Kaen, Thailand

Locations

Country	Name	City	State
Thailand	Khon Kaen University	Nai Muang	Khon Kaen

Sponsors (4)

Lead Sponsor	Collaborator
McMaster University	Canadian Institutes of Health Research (CIHR), Global Alliance for Chronic Diseases (GACD), Khon Kaen University

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intake of raw fish	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.	12 months
Primary	Intake of fruits and vegetables	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.	12 months
Primary	Smoking	Difference in the proportion of smoking habits in the intervention group compared to the control group. Self reported, pre- and post- intervention.	12 months
Primary	Alcoholic beverage intake	Mean difference in the intake of alcoholic beverages in the intervention group compared to the control group. Self reported, pre- and post- intervention.	12 months
Primary	Praziquantel use	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.	12 months
Primary	Stool test (proportion of stool test concentration)	Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.	12 months
Primary	Stool test (mean concentration)	Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.	12 months
Primary	Stages of change for risk behaviours affecting the development of CCA.	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.	12 months
Secondary	Knowledge of preventative measures against CCA	Mean difference in knowledge score about in knowledge of preventative measures against CCA in the intervention group compared to the control group. Measured in questions included in the community survey.	12 months
Secondary	BMI	Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).	12 months
Secondary	Waist circumference	Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)	12 months
Secondary	Blood pressure	Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)	12 months
Secondary	Health literacy	Mean difference in health literacy knowledge score in the intervention group compared to the control group. Self reported, pre- and post- intervention	12 months
Secondary	Quality of life	Mean difference in quality of life in the intervention group compared to the control group. Self reported, pre- and post- intervention. Using the EuroQol-5 dimension-5 level (EQ-5D-5L) tool	12 months