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NCT Number: NCT05321992

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

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.

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Key information

Conditions

Cholangiocarcinoma Adenocarcinoma Adherence Interventions Behavior Carcinoma Health Behavior Health Education Helminthiasis Infections Liver Fluke-Related Cholangiocarcinoma Medication Adherence Neoplasms Neoplasms by Histologic Type Neoplasms, Glandular and Epithelial Opisthorchiasis Parasitic Diseases Patient Acceptance of Health Care Patient Compliance Treatment Adherence and Compliance Trematode Infections

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Khon Kaen University

Phu Wiang, Changwat Khon Kaen, 40002, Thailand

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

eCHEC program

Behavioral

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 outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. Stool test (mean concentration)

    Time frame: 12 months

    Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.

  8. 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.

Secondary outcomes

  1. 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.

  2. 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).

  3. Waist circumference

    Time frame: 12 months

    Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)

  4. Blood pressure

    Time frame: 12 months

    Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)

  5. 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

  6. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Ricardo Angeles, MD, MPH, MHPEd, PhD

CONTACT

[email protected]

905-515-2100 ext. 21203

Sponsors and collaborators

Lead sponsor

McMaster University

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)
  • Global Alliance for Chronic Diseases (GACD)
  • Khon Kaen University

Registry information

Acronym: eCHEC

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Apr 11, 2022
Registry last updated
Nov 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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