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

Not Applicable

Recruiting

• Conditions: Cholangiocarcinoma; Opisthorchiasis; Liver Fluke-Related Cholangiocarcinoma
• Interventions: Behavioral: eCHEC program

• Registration Number: NCT05321992
• Lead Sponsor: McMaster University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-03-08
• Study First Submitted QC: 2022-04-08
• Study First Posted: 2022-04-11
• Study Start: 2024-06-05
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-21
• Primary Completion: 2026-04-01
• Study Completion: 2026-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 480

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
eCHEC Community	eCHEC program	Participants in this arm will be given the eCHEC program as their intervention

Primary Outcome Measures

Name	Time	Method
Intake of raw fish	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	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.	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	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)	12 months	Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.
Alcoholic beverage intake	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	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)	12 months	Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.

Secondary Outcome Measures

Name	Time	Method
BMI	12 months	Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).
Quality of life	12 months	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
Waist circumference	12 months	Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)
Blood pressure	12 months	Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)
Health literacy	12 months	Mean difference in health literacy knowledge score in the intervention group compared to the control group. Self reported, pre- and post- intervention
Knowledge of preventative measures against CCA	12 months	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.

Trial Locations

Locations (1)

Khon Kaen University; 🇹🇭 Nai Muang, Khon Kaen, Thailand