Cross-Cultural Adaptation of a Betel Quid Cessation Program and Evaluation of Its Effectiveness in a Malaysian High-Risk Community
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 2
- 主要终点
- Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Day-22
研究概览
简要总结
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.
详细描述
- Framework of the Intervention:
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.
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.
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.
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. 2. Research Design:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Other optional ingredients such as inclusion of slaked lime and betel leaf in the betel quid are allowed.
- •Age of participant must be 18 years old and above
- •Participants must be residing in study location (Kota Belud, Sabah)
- •Ability to comprehend, converse and read in Bahasa Melayu and their local language (Bajau)
- •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
排除标准
- •Non-Malaysian citizen
- •Participants who are not willing to quit the betel quid chewing habit at the time of the study
- •Women chewers who are pregnant or nursing at the time of study
- •Individuals with psychiatric illness or special social situations that would limit their compliance with study requirements
结局指标
主要结局
Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Day-22
时间窗: 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
Change in the number of participants who self-reported that they had quitted betel quid chewing behaviour from baseline at Month-3
时间窗: 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
次要结局
- Change in the levels of areca nut biomarkers in the saliva sample from baseline at Day-22(Day-22)
- Change in the levels of areca nut biomarkers in the saliva sample from baseline at Month-3(Month-3)
研究者
Mary Melissa A/P Sarimuthu
Principal Investigator
University of Malaya