Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 2:33 PM
Study NCT ID:
NCT05782166
Status:
UNKNOWN
Last Update Posted:
2023-12-06
First Post:
2023-03-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Adapting a Betel Quid Cessation Program for a High-risk Community in Malaysia and Evaluating Its Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020340', 'term': 'Tobacco Use Cessation'}], 'ancestors': [{'id': 'D015438', 'term': 'Health Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-02-22', 'size': 321392, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-12T10:22', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 92}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2024-01-02', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-29', 'studyFirstSubmitDate': '2023-03-12', 'studyFirstSubmitQcDate': '2023-03-12', 'lastUpdatePostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Day-22', 'timeFrame': 'Day-22', 'description': 'A follow-up questionnaire will be used to assess the self-reported cessation rate. This rate will represent the immediate cessation prevalence after the program'}, {'measure': 'Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Month-3', 'timeFrame': 'Month-3', 'description': 'A follow-up questionnaire will be used to assess the self-reported cessation rate. This rate will represent the intermediate-term cessation prevalence of the program'}], 'secondaryOutcomes': [{'measure': 'Change in the levels of areca nut biomarkers in the saliva sample from baseline at Day-22', 'timeFrame': 'Day-22', 'description': "Liquid chromatography mass spectrometry analysis will be done to the saliva samples to assess the level of arena nut biomarkers.\n\nParticipant's areca nut biomarker levels will be compared to a standard cut-off levels; arecoline (60 ng/mL), arecaidine (10 ng/mL), guvacoline (20 ng/mL), and guvacine (6 ng/mL).\n\nBiomarkers level below this cut-off points represent that participants had ceased the chewing habit."}, {'measure': 'Change in the levels of areca nut biomarkers in the saliva sample from baseline at Month-3', 'timeFrame': 'Month-3', 'description': "Liquid chromatography mass spectrometry analysis will be done to the saliva samples to assess the level of arena nut biomarkers.\n\nParticipant's areca nut biomarker levels will be compared to a standard cut-off levels; arecoline (60 ng/mL), arecaidine (10 ng/mL), guvacoline (20 ng/mL), and guvacine (6 ng/mL).\n\nBiomarkers level below this cut-off points represent that participants had ceased the chewing habit."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Betel Quid', 'Cessation Program', 'Effectiveness'], 'conditions': ['Betel Nut Chewer', 'Tobacco Cessation']}, 'referencesModule': {'references': [{'pmid': '21440366', 'type': 'BACKGROUND', 'citation': 'Al-Rmalli SW, Jenkins RO, Haris PI. 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BMC Public Health. 2008 Jun 5;8:199. doi: 10.1186/1471-2458-8-199.'}, {'type': 'BACKGROUND', 'citation': 'Yusoff MSB. (2019). ABC of content validation and content validity index calculation. Education in Medicine Journal, 11(2):49-54.'}, {'type': 'BACKGROUND', 'citation': 'Zain, R. B., Fukano, F., Razak, I. A., Shanmuhasuntharam, P., Ikeda, N., & Rahman, Z. A. A. (1999). Risk factors for oral leukoplakia: a comparison of two ethnic groups in Malaysia. Oral oncology, 6, 207-10.'}]}, 'descriptionModule': {'briefSummary': "The practice of betel quid chewing is known as the top 3 causes of oral cancers in Malaysia. The devastating part among Malaysians are that more than 50% of these cancer patients present at a later stage of this disease necessitating a massive surgical procedure and a costly oncological treatment to remove the tumour and restore the vital structures in the head and neck regions of the patients. In 2010, World Health Organisation recognised that the users of betel quid are having a 'Dependency Syndrome' similar to that of a cigarette smoking. Since then, much research has been focussed upon the 'addictive nature' and the cessation of this ill-health behaviour.\n\nMalaysia's current plight is its strikingly high prevalence of betel quid users within its high-risk communities. The other challenge is the widely scattered high-risk communities across the diverse geography, locality, ethnicity, culture and native languages across the country that make cessation not an easy task but an uphill battle.\n\nThe latest available report in 2011 showed that the females in Sabah and Sarawak's indigenous communities presented with a prevalence of 28.4% being current chewers. This prevalence was way greater than the global prevalence of 10-20% of betel quid chewers reported worldwide. The female predominance among the betel quid users in Malaysia is another matter of concern as studies had claimed that females are less likely to cease chewing habit compared to their male counterparts.\n\nFortunately, in 2015, a feasibility study was conducted to adapt an intensive smoking cessation intervention to cater for betel quid chewers which received a high cessation rate of 65%. Later in 2018, researchers incorporated a saliva test to assess the effectiveness of a group-based intensive betel quid cessation program which also yielded a high cessation rate of 38% among the participants.\n\nSince there is no existing betel quid cessation intervention in Malaysia, this study aims to adapt a betel quid cessation program for a high-risk community in Malaysia.\n\nThis study hypothesised that the intervention group will produce a significantly greater cessation rate compared to the control group at the 3-months follow-up assessment.", 'detailedDescription': "1. Framework of the Intervention:\n\n This study will utilise a Cognitive Behavioural Therapy (CBT) framework as study showed that CBT framework yielded better success rates in betel quid cessation compared to a Basic Health Education talk or module alone. CBT provided education, encouragement, support and equipped participants with coping skills which was repeated and emphasized at every follow-up.\n\n The cognitive component tackles the chewer's attitude and health beliefs by educating the participants on the carcinogenicity of betel quid. Study revealed that betel quid chewers underestimated the deleterious health effects contributed by their chewing behaviour.\n\n The behaviour component targets to enhance participant's self-efficacy by substituting their chewing-promoting behaviours to behaviours which are more conducive to quitting. This involves identifying and managing chewing triggers, making supportive lifestyle changes and preparing social situation responses in advance to manage peer or social event pressures.\n\n BENIT intervention was selected as the intervention-of-choice to be cross-culturally adapted in Malaysia due to few reasons. Firstly, it was the first intervention that targets primarily the users of areca nut in an indigenous population which was similar to the study population of the high-risk groups in Malaysia. Most chewers in Malaysia chew areca nut singly and does not incorporate smokeless tobacco into their quid preparation. Secondly, the tropical marine climate of Guam Island was similar to the study site in Malaysia (Kota Belud, Sabah). Thirdly, the age of the chewers in Malaysia were mostly 40 years of age and above, thus BENIT was more appropriate to be adapted in Malaysia. Even though there was peer-led betel quid cessation intervention in Pakistan, it was not chosen as it targeted adolescent population in the school setting.\n2. Research Design:\n\n This is a comparative prospective community trial which utilises a cluster-randomised controlled trial design involving a Bajau indigenous community in Sabah, Malaysia with a 1:1 allocation ratio. The clusters are Bajau villages that practises betel quid chewing habits in Kota Belud district in Sabah. The Bajau villages are the unit of randomisation. There are 39 Bajau villages in Kota Belud, Sabah. The eligible villages will be randomised into intervention and control groups based on the required sample size (46 participants in each arm). The intervention group will receive an educational booklet and a structured betel quid intervention program. The control group will only receive an educational booklet.\n3. Research Methodology\n\nThere will be 3 phases involved in the conduct of this study.\n\n3.1 Phase 1 : Adaptation, Validation and Translation of the Questionnaire, Educational Booklet and Intervention Module\n\nThree components from the BENIT intervention will undergo the cross-cultural adaptation process; namely the baseline and follow-up questionnaire, educational booklet and intervention module. The adapted material will be face validated by study investigators and content validated by smoking cessation experts from Department of Social and Preventive Medicine and Centre of Addiction Science, Universiti Malaya. The validated materials will undergo forward and backward translation to the target language 'Bahasa Melayu' by bilingual linguistic experts.\n\n3.2 Phase 2 : Pretest and Pilot test of the study\n\nThe forward translated materials will then be pretested among 8-10 participants from a Bajau community in Kota Belud, Sabah, which will not be selected as the sample of the field study to ensure the clarity and non-ambiguity of the translated material to both the interviewer and subject in terms of conceptual and operational equivalence. A subsequent pilot test will be done on the pretested material to assess its feasibility and its psychometric properties.\n\n3.3 Phase 3 : Implementation of the study (Field Work)\n\nA two-days training will be conducted by the principal investigator for the study facilitators who will be involved as questionnaire and worksheet interviewers and verbal translators for this study. A simulation session will be planned to practically expose the facilitators to the order and details of the intervention and study.\n\nPrior to the start of the intervention, a promotional initiative will be conducted with the village heads 3 weeks before the implementation of the study to provide knowledge and to convince the village heads regarding the ill effects of the chewing habit to encourage his villagers to participate in the cessation program.\n\n3.3.3 Implementation of the Study\n\nControl group A community screening program will be organised to recruit the eligible participants. Participants will be required to provide consent, complete a baseline questionnaire through a face-to-face interview and to provide saliva sample on Day-1. An educational booklet will be provided to participants on the same day. On Day-22 and Month-3, participants are required to return to complete a follow-up questionnaire and provide saliva sample for assessment.\n\nIntervention Group A community screening program will be organised to recruit the eligible participants. Participants will be required to provide consent, complete a baseline questionnaire through a face-to-face interview and to provide saliva sample on Day-0. An educational booklet will be provided to participants on the same day.\n\nOn Day-1 (Session 1), a brief talk will be given regarding the nature of intervention in which participants will undergo 5 sessions of support group designed to assist them to quit betel quid chewing habit over the next 22 days. Each session will take approximately 1-2 hours. An educational talk will be delivered focussing in a more detailed manner on the topics covered in the educational booklets. Participants will later be introduced to three topical worksheets; Trigger Monitoring Logs, Trigger Management Logs and Arecoline Fading Worksheet.\n\nOn Day-8 (Session 2), a summary of the triggers experienced by the participants within that community (village) will be gathered and potential strategies to manage those triggers will be discussed with the participants. Participants will be briefed that quitting chewing behaviour is more than cutting down the betel quid numbers per day or antagonising the chewing triggers. A lifestyle change is very pertinent in making an ex-chewer remain abstinent. Strategies such as lifestyle changes, excuses to reject chew invites and usage of fake chew objects will be taught to participants to empower them to manage their triggers. Two worksheets will be introduced to the participants; Non-chewing Game Plan Worksheet and Coping with High Risk Situation Worksheet. At the end of Session 2, participants will be reminded of the quit day that will be on morning of Day 15 (Session 3).\n\nOn Day-15 (Session 3), it will be the quit date for the participants. Discussion regarding potential withdrawal symptoms post-quitting and withdrawal coping strategies will be held. A Social Support for No Betel Quid Chewing Worksheet will be introduced. This worksheet is a tool to maximise the social support of the participant to quit the behaviour. Social support can be a good source of motivation and may also act as a buffer in stressful situations. Thus, they play a positive role in the success of participants in remaining abstinent of their chewing behaviour.\n\nOn Day-18 (Session 4), discussion on the overall quitting experience of the participants will be held and the negative health effects of betel quid chewing will be emphasized. Additional coping strategies will be discussed to address newer urges to chew. Reinforcement will be given for both quitters and current chewers through a talk by the principal investigator.\n\nOn Day-22 (Session 5), a follow-up questionnaire will be completed. A discussion on the overall quitting experience will be held. Strategies for Managing Thoughts worksheet will be introduced. This is a strategy to manage the thoughts that participants might have throughout their quitting journey. This method is based on the notion that mood is related to the balance of the positive and negative thoughts. When negative thoughts outweighed the positive thoughts, the result is a depressive, anxious, angry or other symptoms that may precipitate the behaviour of a risk habit such as chewing to come through. At the end of session 5, participant's saliva samples will be collected for assessment.\n\nOn Follow up Month-3, participants will return for another follow-up questionnaire completion and for the final saliva sample collection.\n\nSaliva Sample Collection :\n\nAn amount of 1 - 2 mL saliva sample will be collected during assessment by the principal investigator via 'passive drool' method with a 20 mL length, conical shaped polypropylene tubes and initially stored at -20◦C after collection in an insulated cooler box with reusable ice packs. The principal investigator will transport the biospecimen to the Biotechnology Research Institute (BRI), Universiti Malaysia Sabah (UMS), Sabah, Malaysia. Upon arrival to the lab, it should be stored at -80 ◦C until analysis is done.\n\nSaliva Sample Analysis :\n\nThe Liquid Chromatography-Mass Spectrometry (LCMS) analysis will be run by staff at the Biotechnology Research Institute (BRI), Universiti Malaysia Sabah (UMS). The BRI lab is located at Kota Kinabalu, Sabah which is about 1 to 1.5 hours from the study site and precaution will be taken to deliver samples within 8 hours after collection due to the quick disappearance property of areca nut biomarkers after 8 hours of collection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. A self-reported betel quid chewer who has been practising chewing habit for the past 6 months with atleast 2-3 chewing episodes per week. The ingredient of betel quid must include areca nut without or without smokeless tobacco.\n2. Other optional ingredients such as inclusion of slaked lime and betel leaf in the betel quid are allowed.\n3. Age of participant must be 18 years old and above\n4. Participants must be residing in study location (Kota Belud, Sabah)\n5. Ability to comprehend, converse and read in Bahasa Melayu and their local language (Bajau)\n6. Participants who are able to provide written consent and agree to comply with all protocol-specified procedures such as providing saliva samples, participating in five 1-2 hours sessions of intervention over 22 days and agree to attend follow-up session on the third month\n\nExclusion Criteria:\n\n1. Non-Malaysian citizen\n2. Participants who are not willing to quit the betel quid chewing habit at the time of the study\n3. Women chewers who are pregnant or nursing at the time of study\n4. Individuals with psychiatric illness or special social situations that would limit their compliance with study requirements'}, 'identificationModule': {'nctId': 'NCT05782166', 'acronym': 'M-BENIT', 'briefTitle': 'Adapting a Betel Quid Cessation Program for a High-risk Community in Malaysia and Evaluating Its Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'University of Malaya'}, 'officialTitle': 'Cross-Cultural Adaptation of a Betel Quid Cessation Program and Evaluation of Its Effectiveness in a Malaysian High-Risk Community', 'orgStudyIdInfo': {'id': 'RSCH ID-23-00412-TVU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Betel Quid Cessation via Educational Booklet', 'description': 'Participants will be given only an educational booklet on screening day (Day-1) and will be followed up on Day-22 and Month-3 to assess their current chewing status and other related parameters.', 'interventionNames': ['Behavioral: Betel Quid Educational Booklet']}, {'type': 'EXPERIMENTAL', 'label': 'Betel Quid Cessation via Educational Booklet & Intervention Module', 'description': 'Participants will undergo a 5-intervention sessions which will enhance their self-efficacy o quit their chewing behaviour. During the intervention sessions, they will be guided on how to monitor their chewing triggers, the lifestyle changes that they can potentially make, how to tap on their social support system to aid in their cessation efforts and others. The intervention will last for 22 days and a follow-up session will be made on Month-3.', 'interventionNames': ['Behavioral: Betel Quid Educational Booklet', 'Behavioral: Betel Quid Cessation Intervention Module']}], 'interventions': [{'name': 'Betel Quid Educational Booklet', 'type': 'BEHAVIORAL', 'description': "Eligible and consented participants will be interviewed for baseline questionnaire completion. Details regarding participants' demographics, betel quid chewing behaviours, betel quid composition, betel quid dependency levels, reasons for chewing, readiness and self-perceived barriers to quit will be obtained. Saliva samples will be obtained.\n\nParticipants will be given an educational booklet containing general information regarding betel quid and areca nut, risk associated with betel quid chewing behaviour, cessation strategies that are modeled after tobacco cessation and some relevant researcher's contact details.\n\nParticipants will be followed up at Day-22 and Month-3 for information regarding compliance, current chewing status, number of habit cut-down (quid/day), total number of sessions attended and current betel quid composition. Saliva samples will be taken during follow-ups for the cessation verification of participant's chewing behaviour.", 'armGroupLabels': ['Betel Quid Cessation via Educational Booklet', 'Betel Quid Cessation via Educational Booklet & Intervention Module']}, {'name': 'Betel Quid Cessation Intervention Module', 'type': 'BEHAVIORAL', 'description': "All eligible and consented participants will be interviewed for baseline questionnaire completion. Details regarding participants' demographics, betel quid chewing behaviours, betel quid composition, betel quid dependency levels, reasons for chewing, readiness and self-perceived barriers to quit will be obtained. Saliva samples will be obtained.\n\nAn interactive, educational talk will be given regarding the content of the educational booklet.\n\nParticipants will undergo a 5-intervention sessions cessation program (M-BENIT) and will be given topical worksheets on every session to monitor their triggers, lifestyle changes, social support system and others.\n\nParticipants will be followed up at Day-22 and Month-3 for information regarding compliance, current chewing status, number of habit cut-down (quid/day), total number of sessions attended and current betel quid composition. Saliva samples will be taken during follow-ups for the cessation verification of participant's chewing behaviour.", 'armGroupLabels': ['Betel Quid Cessation via Educational Booklet & Intervention Module']}]}, 'contactsLocationsModule': {'locations': [{'zip': '88590', 'city': 'Kota Kinabalu', 'state': 'Sabah', 'country': 'Malaysia', 'contacts': [{'name': 'Azhani Zakaria, DrDPH', 'role': 'CONTACT', 'email': 'drazhani@moh.gov.my', 'phone': '+60199101781'}], 'facility': 'State Dental Health Department', 'geoPoint': {'lat': 5.9749, 'lon': 116.0724}}], 'centralContacts': [{'name': 'Mary Melissa Sarimuthu, MCOH', 'role': 'CONTACT', 'email': 'lissary04@gmail.com', 'phone': '+60196525710'}, {'name': 'Jennifer Geraldine Doss, PhD', 'role': 'CONTACT', 'email': 'jendoss@um.edu.my', 'phone': '+603-79672748', 'phoneExt': '4805'}], 'overallOfficials': [{'name': 'Jennifer Geraldine Doss, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Universiti Malaya'}, {'name': 'Amer Siddiq Amer Nordin, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Universiti Malaya'}, {'name': 'Mary Melissa Sarimuthu, MCOH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universiti Malaya'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Malaya', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Hawaii Cancer Research Center', 'class': 'OTHER'}, {'name': 'University of Guam', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Mary Melissa A/P Sarimuthu', 'investigatorAffiliation': 'University of Malaya'}}}}