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

March 12, 2024 updated by: McMaster University

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

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

480

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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
        • Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

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
Time Frame: 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.
12 months
Intake of fruits and vegetables
Time Frame: 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.
12 months
Smoking
Time Frame: 12 months
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
Time Frame: 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.
12 months
Praziquantel use
Time Frame: 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.
12 months
Stool test (proportion of stool test concentration)
Time Frame: 12 months
Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.
12 months
Stool test (mean concentration)
Time Frame: 12 months
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.
Time Frame: 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.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 1, 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 (Actual)

March 15, 2024

Last Update Submitted That Met QC Criteria

March 12, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cholangiocarcinoma

Clinical Trials on eCHEC program

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Serbia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe