Clinical trial NCT05321992: Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
Official title: Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholangiocarcinoma
Liver Fluke-Related Cholangiocarcinoma
Opisthorchiasis
Keywords: health education
community-based education
complex intervention
Lead sponsor: McMaster University
Sponsor class: OTHER
Collaborators: name: Khon Kaen University
name: Global Alliance for Chronic Diseases (GACD)
name: Canadian Institutes of Health Research (CIHR)
First posted: 2022-04-11
Enrollment: 480
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Intake of raw fish
timeFrame: 12 months
measure: Intake of fruits and vegetables
timeFrame: 12 months
measure: Smoking
timeFrame: 12 months
measure: Alcoholic beverage intake
timeFrame: 12 months
measure: Praziquantel use
timeFrame: 12 months
measure: Stool test (proportion of stool test concentration)
timeFrame: 12 months
measure: Stool test (mean concentration)
timeFrame: 12 months
measure: Stages of change for risk behaviours affecting the development of CCA.
timeFrame: 12 months
Secondary outcomes:
measure: Knowledge of preventative measures against CCA
timeFrame: 12 months
measure: BMI
timeFrame: 12 months
measure: Waist circumference
timeFrame: 12 months
measure: Blood pressure
timeFrame: 12 months
measure: Health literacy
timeFrame: 12 months
measure: Quality of life
timeFrame: 12 months
Other outcomes:
Locations:
city: Nai Muang
country: Thailand
facility: Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: McMaster University
name: Gina Agarwal, MBBS, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Khon Kaen University
name: Pattapong Kessomboon, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: