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

NCT05321992 | Recruiting

• 2 other identifiers: 060900410513955
• Study Type: interventional
• Target: 480
• Locations: 1 country
• Sites: 1

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. 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. 2.Incorporate the program we develop in healthcare to prevent liver cancer in Thailand.

Conditions

Cholangiocarcinoma; Liver Fluke-Related Cholangiocarcinoma; Opisthorchiasis

Keywords

health education; community-based education; complex intervention

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (6)

• Knowledge of preventative measures against CCA

  12 months

• BMI

  12 months

• Waist circumference

  12 months

• Blood pressure

  12 months

• Health literacy

  12 months

Study Arms (2)

Usual Care Community

NO INTERVENTION

Participants in this arm will not be given the eCHEC program

eCHEC Community

ACTIVE COMPARATOR

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

Behavioral: eCHEC program

Interventions

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

eCHEC Community

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• any individual residing in one of the 16 villages selected in the Khon Kaen province of Thailand, aged 20 and older

You may not qualify if:

• 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

Sponsors & Collaborators

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

Study Sites (1)

Khon Kaen University

Phu Wiang, Changwat Khon Kaen, 40002, Thailand

RECRUITING

MeSH Terms

Conditions

Cholangiocarcinoma; Opisthorchiasis; Health Education

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Trematode Infections; Helminthiasis; Parasitic Diseases; Infections; Adherence Interventions; Medication Adherence; Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gina Agarwal, MBBS, PhD

  McMaster University

  PRINCIPAL INVESTIGATOR

• Pattapong Kessomboon, MD, PhD

  Khon Kaen University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ricardo Angeles, MD, MPH, MHPEd, PhD

CONTACT

905-515-2100; angelesric@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2022
• First Posted: April 11, 2022
• Study Start: June 5, 2024
• Primary Completion: April 1, 2026
• Study Completion: April 1, 2026
• Last Updated: November 21, 2024

Record last verified: 2024-11

Locations

TH (1)