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

Primary Purpose

Cholangiocarcinoma, Liver Fluke-Related Cholangiocarcinoma, Opisthorchiasis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
eCHEC program
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cholangiocarcinoma focused on measuring health education, community-based education, complex intervention

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Usual Care Community

eCHEC Community

Arm Description

Participants in this arm will not be given the eCHEC program

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

Outcomes

Primary Outcome Measures

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.
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.
Smoking
Difference in the proportion of smoking habits in the intervention group compared to the control group. Self reported, pre- and post- intervention.
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.
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.
Stool test (proportion of stool test concentration)
Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.
Stool test (mean concentration)
Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.
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.

Secondary Outcome Measures

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

Full Information

First Posted
March 8, 2022
Last Updated
February 6, 2023
Sponsor
McMaster University
Collaborators
Khon Kaen University, Global Alliance for Chronic Diseases (GACD), Canadian Institutes of Health Research (CIHR)
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1. Study Identification

Unique Protocol Identification Number
NCT05321992
Brief Title
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
Acronym
eCHEC
Official Title
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
June 1, 2023 (Anticipated)
Primary Completion Date
April 1, 2026 (Anticipated)
Study Completion Date
April 1, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McMaster University
Collaborators
Khon Kaen University, Global Alliance for Chronic Diseases (GACD), Canadian Institutes of Health Research (CIHR)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholangiocarcinoma, Liver Fluke-Related Cholangiocarcinoma, Opisthorchiasis
Keywords
health education, community-based education, complex intervention

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
480 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care Community
Arm Type
No Intervention
Arm Description
Participants in this arm will not be given the eCHEC program
Arm Title
eCHEC Community
Arm Type
Active Comparator
Arm Description
Participants in this arm will be given the eCHEC program as their intervention
Intervention Type
Behavioral
Intervention Name(s)
eCHEC program
Intervention Description
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
Primary Outcome Measure Information:
Title
Intake of raw fish
Description
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.
Time Frame
12 months
Title
Intake of fruits and vegetables
Description
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.
Time Frame
12 months
Title
Smoking
Description
Difference in the proportion of smoking habits in the intervention group compared to the control group. Self reported, pre- and post- intervention.
Time Frame
12 months
Title
Alcoholic beverage intake
Description
Mean difference in the intake of alcoholic beverages in the intervention group compared to the control group. Self reported, pre- and post- intervention.
Time Frame
12 months
Title
Praziquantel use
Description
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.
Time Frame
12 months
Title
Stool test (proportion of stool test concentration)
Description
Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.
Time Frame
12 months
Title
Stool test (mean concentration)
Description
Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.
Time Frame
12 months
Title
Stages of change for risk behaviours affecting the development of CCA.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Knowledge of preventative measures against CCA
Description
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.
Time Frame
12 months
Title
BMI
Description
Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).
Time Frame
12 months
Title
Waist circumference
Description
Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)
Time Frame
12 months
Title
Blood pressure
Description
Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)
Time Frame
12 months
Title
Health literacy
Description
Mean difference in health literacy knowledge score in the intervention group compared to the control group. Self reported, pre- and post- intervention
Time Frame
12 months
Title
Quality of life
Description
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
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ricardo Angeles, MD, MPH, MHPEd, PhD
Phone
905-515-2100
Ext
21203
Email
angelesric@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gina Agarwal, MBBS, PhD
Organizational Affiliation
McMaster University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pattapong Kessomboon, MD, PhD
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Nai Muang
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Learn more about this trial

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

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