Ignite Creation Date:
2025-12-24 @ 3:56 PM
Ignite Modification Date:
2026-02-24 @ 5:05 AM
Study NCT ID:
NCT05321992
Status:
RECRUITING
Last Update Posted:
2024-11-21
First Post:
2022-03-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018281', 'term': 'Cholangiocarcinoma'}, {'id': 'D009889', 'term': 'Opisthorchiasis'}, {'id': 'D006266', 'term': 'Health Education'}], 'ancestors': [{'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D014201', 'term': 'Trematode Infections'}, {'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D000099060', 'term': 'Adherence Interventions'}, {'id': 'D055118', 'term': 'Medication Adherence'}, {'id': 'D010349', 'term': 'Patient Compliance'}, {'id': 'D010342', 'term': 'Patient Acceptance of Health Care'}, {'id': 'D000074822', 'term': 'Treatment Adherence and Compliance'}, {'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 480}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-11-19', 'studyFirstSubmitDate': '2022-03-08', 'studyFirstSubmitQcDate': '2022-04-08', 'lastUpdatePostDateStruct': {'date': '2024-11-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intake of raw fish', 'timeFrame': '12 months', '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.'}, {'measure': 'Intake of fruits and vegetables', 'timeFrame': '12 months', '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.'}, {'measure': 'Smoking', 'timeFrame': '12 months', 'description': 'Difference in the proportion of smoking habits in the intervention group compared to the control group. Self reported, pre- and post- intervention.'}, {'measure': 'Alcoholic beverage intake', 'timeFrame': '12 months', 'description': 'Mean difference in the intake of alcoholic beverages in the intervention group compared to the control group. Self reported, pre- and post- intervention.'}, {'measure': 'Praziquantel use', 'timeFrame': '12 months', '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.'}, {'measure': 'Stool test (proportion of stool test concentration)', 'timeFrame': '12 months', 'description': 'Difference in the proportion of positive stool test of concentration of O. viverrini, pre- and post-intervention.'}, {'measure': 'Stool test (mean concentration)', 'timeFrame': '12 months', 'description': 'Difference in the mean concentration of O. viverrini in the stool test, pre- and post-intervention.'}, {'measure': 'Stages of change for risk behaviours affecting the development of CCA.', 'timeFrame': '12 months', '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.'}], 'secondaryOutcomes': [{'measure': 'Knowledge of preventative measures against CCA', 'timeFrame': '12 months', '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.'}, {'measure': 'BMI', 'timeFrame': '12 months', 'description': 'Cardiobolic measure linked to developing cancer. Change in the mean body mass index calculated from height and weight (self-reported).'}, {'measure': 'Waist circumference', 'timeFrame': '12 months', 'description': 'Cardiobolic measure linked to developing cancer. Change in the mean waist circumference (measured with measuring tape)'}, {'measure': 'Blood pressure', 'timeFrame': '12 months', 'description': 'Cardiobolic measure linked to developing cancer. Change in the mean measured blood pressure (automated, validated device)'}, {'measure': 'Health literacy', 'timeFrame': '12 months', 'description': 'Mean difference in health literacy knowledge score in the intervention group compared to the control group. Self reported, pre- and post- intervention'}, {'measure': 'Quality of life', 'timeFrame': '12 months', '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'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['health education', 'community-based education', 'complex intervention'], 'conditions': ['Cholangiocarcinoma', 'Liver Fluke-Related Cholangiocarcinoma', 'Opisthorchiasis']}, 'descriptionModule': {'briefSummary': '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.\n\nThe 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:\n\n1. Increase understanding in the community that make it difficult to prevent liver cancer, as well as community characteristics that can help prevent liver cancer;\n2. Incorporate the program we develop in healthcare to prevent liver cancer in Thailand.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* any individual residing in one of the 16 villages selected in the Khon Kaen province of Thailand, aged 20 and older\n\nExclusion Criteria:\n\n* any individual 19 years or younger\n* any individual not residing in one of the 16 pre-selected villages in the Khon Kaen province of Thailand'}, 'identificationModule': {'nctId': 'NCT05321992', 'acronym': 'eCHEC', 'briefTitle': 'Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Evaluating a Community-Based Behaviour Change Communication Model to Prevent Cholangiocarcinoma in Khon Kaen, Thailand', 'orgStudyIdInfo': {'id': '0609004105'}, 'secondaryIdInfos': [{'id': '13955', 'type': 'OTHER', 'domain': 'HiREB'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care Community', 'description': 'Participants in this arm will not be given the eCHEC program'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'eCHEC Community', 'description': 'Participants in this arm will be given the eCHEC program as their intervention', 'interventionNames': ['Behavioral: eCHEC program']}], 'interventions': [{'name': 'eCHEC program', 'type': 'BEHAVIORAL', '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', 'armGroupLabels': ['eCHEC Community']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Phu Wiang', 'state': 'Changwat Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'facility': 'Khon Kaen University', 'geoPoint': {'lat': 16.65259, 'lon': 102.37555}}], 'centralContacts': [{'name': 'Ricardo Angeles, MD, MPH, MHPEd, PhD', 'role': 'CONTACT', 'email': 'angelesric@gmail.com', 'phone': '905-515-2100', 'phoneExt': '21203'}], 'overallOfficials': [{'name': 'Gina Agarwal, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'McMaster University'}, {'name': 'Pattapong Kessomboon, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Khon Kaen University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Khon Kaen University', 'class': 'OTHER'}, {'name': 'Global Alliance for Chronic Diseases (GACD)', 'class': 'OTHER'}, {'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}