Tobacco Cessation Clinical Trial
— M-BENITOfficial title:
Cross-Cultural Adaptation of a Betel Quid Cessation Program and Evaluation of Its Effectiveness in a Malaysian High-Risk Community
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. Malaysia'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. The 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. Fortunately, 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. Since 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. This 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.
Status | Not yet recruiting |
Enrollment | 92 |
Est. completion date | December 31, 2024 |
Est. primary completion date | June 30, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. 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. 2. Other optional ingredients such as inclusion of slaked lime and betel leaf in the betel quid are allowed. 3. Age of participant must be 18 years old and above 4. Participants must be residing in study location (Kota Belud, Sabah) 5. Ability to comprehend, converse and read in Bahasa Melayu and their local language (Bajau) 6. 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 Exclusion Criteria: 1. Non-Malaysian citizen 2. Participants who are not willing to quit the betel quid chewing habit at the time of the study 3. Women chewers who are pregnant or nursing at the time of study 4. Individuals with psychiatric illness or special social situations that would limit their compliance with study requirements |
Country | Name | City | State |
---|---|---|---|
Malaysia | State Dental Health Department | Kota Kinabalu | Sabah |
Lead Sponsor | Collaborator |
---|---|
University of Malaya | University of Guam, University of Hawaii Cancer Research Center |
Malaysia,
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* Note: There are 71 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Day-22 | 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 | Day-22 | |
Primary | Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Month-3 | 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 | Month-3 | |
Secondary | Change in the levels of areca nut biomarkers in the saliva sample from baseline at Day-22 | Liquid chromatography mass spectrometry analysis will be done to the saliva samples to assess the level of arena nut biomarkers.
Participant'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). Biomarkers level below this cut-off points represent that participants had ceased the chewing habit. |
Day-22 | |
Secondary | Change in the levels of areca nut biomarkers in the saliva sample from baseline at Month-3 | Liquid chromatography mass spectrometry analysis will be done to the saliva samples to assess the level of arena nut biomarkers.
Participant'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). Biomarkers level below this cut-off points represent that participants had ceased the chewing habit. |
Month-3 |
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