CholangiocarcinomaeCHECNCT05321992
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
A study testing eCHEC program in people with Cholangiocarcinoma and Liver Fluke-Related Cholangiocarcinoma, run by McMaster University at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 20 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cholangiocarcinoma, Liver Fluke-Related Cholangiocarcinoma, Opisthorchiasis
- What is being tested?
- eCHEC program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 480 participants
- Where
- 1 siteThailand
- Study dates
- 5 Jun 2024to 1 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- any individual residing in one of the 16 villages selected in the Khon Kaen province of Thailand, aged 20 and older
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Thailand1 site, 1 recruiting
- Recruiting
Khon Kaen University
Phu Wiang, Changwat Khon Kaen, 40002
About this study
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.
- Being tested
- eCHEC program
- Keywords
- health education, community-based education, complex intervention
- Medical subject headings
- Cholangiocarcinoma, Opisthorchiasis, Health Education
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eCHEC programBehavioural
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
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: eCHEC program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 12 months
Stool test (mean concentration)
Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.
Measured: 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.
Measured: 12 months
Secondary outcomes (6)
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.
Measured: 12 months
BMI
Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).
Measured: 12 months
Waist circumference
Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)
Measured: 12 months
Blood pressure
Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)
Measured: 12 months
Health literacy
Mean difference in health literacy knowledge score in the intervention group compared to the control group. Self reported, pre- and post- intervention
Measured: 12 months
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
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start5 Jun 2024
- Primary completion1 Apr 2026 (estimated)
- Study completion1 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CholangiocarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 480 participants (estimated)
Sponsor and investigators
- Lead sponsor
- McMaster University
- Sponsor type
- University, hospital or other
- Collaborators
- Khon Kaen University, Global Alliance for Chronic Diseases (GACD), Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Gina Agarwal, MBBS, PhD, Principal investigator, McMaster UniversityPattapong Kessomboon, MD, PhD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05321992
- Sponsor's protocol ID
- 0609004105
- Other IDs
- 13955
- Acronym
- eCHEC
- Status last verified
- Nov 2024
- First submitted
- 8 Mar 2022
- Last updated
- 21 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
- ClinicalTrials.gov ID
- NCT05321992
- Acronym / sponsor ID
- eCHEC / 0609004105
- Keywords
- health education, community-based education, complex intervention
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 480 participants (estimated)
- Lead sponsor
- McMaster UniversityUniversity, hospital or other
- Collaborators
- Khon Kaen University, Global Alliance for Chronic Diseases (GACD), Canadian Institutes of Health Research (CIHR)
- Study start
- 5 Jun 2024 (actual)
- Primary completion
- 1 Apr 2026 (estimated)
- Study completion
- 1 Apr 2026 (estimated)
- First posted
- 11 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care Community | No intervention | –Participants in this arm will not be given the eCHEC program |
| eCHEC Community | Active comparator | Behavioral: eCHEC programParticipants in this arm will be given the eCHEC program as their intervention |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- any individual residing in one of the 16 villages selected in the Khon Kaen province of Thailand, aged 20 and older
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eCHEC programThe 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 | Behavioural | eCHEC Community |
Primary outcome
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.
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.
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.
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.
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.
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.
Stool test (mean concentration)
Time frame: 12 months
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.
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.
6 secondary outcomes
Knowledge of preventative measures against CCA
Time frame: 12 months
BMI
Time frame: 12 months
Waist circumference
Time frame: 12 months
Blood pressure
Time frame: 12 months
Health literacy
Time frame: 12 months
Quality of life
Time frame: 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Gina Agarwal, MBBS, PhD principal investigator
McMaster University
Pattapong Kessomboon, MD, PhD principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing eCHEC program in people with Cholangiocarcinoma and Liver Fluke-Related Cholangiocarcinoma, run by McMaster University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ricardo Angeles, MD, MPH, MHPEd, PhD (905-515-2100 ext. 21203, angelesric@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intake of raw fish (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2024.