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

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.

Study Overview

• Status: Recruiting
• Conditions: Cholangiocarcinoma; Liver Fluke-Related Cholangiocarcinoma; Opisthorchiasis
• Intervention / Treatment: Behavioral: eCHEC program

• Study Type: Interventional
• Enrollment (Estimated): 480
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Ricardo Angeles, MD, MPH, MHPEd, PhD; Phone Number: 21203 905-515-2100; Email: angelesric@gmail.com

Study Locations

• Thailand
  • Khon Kaen
    • Nai Muang, Khon Kaen, Thailand, 40002
      • Recruiting
      • Khon Kaen University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Usual Care Community; Participants in this arm will not be given the eCHEC program
Active Comparator: eCHEC Community; Participants in this arm will be given the eCHEC program as their 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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
Stool test (mean concentration)	Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.	12 months
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
BMI	Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).	12 months
Waist circumference	Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)	12 months
Blood pressure	Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)	12 months
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
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

Collaborators and Investigators

• Sponsor: McMaster University
• Collaborators: Canadian Institutes of Health Research (CIHR); Khon Kaen University; Global Alliance for Chronic Diseases (GACD)
• Investigators: Principal Investigator: Pattapong Kessomboon, MD, PhD, Khon Kaen University; Principal Investigator: Gina Agarwal, MBBS, PhD, McMaster University

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2024
• Primary Completion (Estimated): April 1, 2026
• Study Completion (Estimated): April 1, 2026

Study Registration Dates

• First Submitted: March 8, 2022
• First Submitted That Met QC Criteria: April 8, 2022
• First Posted (Actual): April 11, 2022

Study Record Updates

• Last Update Posted (Estimated): November 21, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: health education; complex intervention; community-based education
• Additional Relevant MeSH Terms: Neoplasms; Infections; Neoplasms by Histologic Type; Neoplasms, Glandular and Epithelial; Adenocarcinoma; Parasitic Diseases; Carcinoma; Helminthiasis; Trematode Infections; Cholangiocarcinoma; Opisthorchiasis
• Other Study ID Numbers: 0609004105; 13955 (Other Identifier: HiREB)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No