Clinical trial NCT02167295: Biobehavioral and Cultural Determinants of Betel Quid Chewing, Dependence, and Withdrawal in Taiwan
Official title: Biobehavioral and Cultural Determinants of Betel Quid Chewing, Dependence, and Withdrawal in Taiwan
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Smoking
Betel Nut
Keywords: betel nut
dependence
withdraw
deprivation test
Lead sponsor: China Medical University Hospital
Sponsor class: OTHER
Collaborators: name: M.D. Anderson Cancer Center
First posted: 2014-06-19
Enrollment: 77
Sex: ALL
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 1. 47 participants will be invited to participate in a qualitative study that includes focus group and in-depth structured interviews that examine the social and cultural context that surrounds continued use and cessation of betel quid consumption.
2. 30 male and female healthy individuals who currently both chew betel quid and smoke cigarettes will be invited to attend 3 separate sessions at CMUH and complete a self-report questionnaire specifically designed to measure betel quid withdrawal symptoms, and the relationship between betel quid chewing and cigarette smoking withdrawal. This application represents the first step in the development of a multi-phase, multidisciplinary betel quid chewing research program.

Brief summary: Cancer of the oral cavity is one of the fastest growing cancers among men in Taiwan. Previous research has established a strong link between betel quid chewing, a common practice among Taiwanese men, and oral cancer. However, despite the strong association, no attempt has been made to develop behavioral measures to facilitate betel quid cessation. This application extends upon existing collaboration between MD Anderson and China Medical University Hospital (CMUH) and seeks to characterize betel quid chewers and their withdrawal symptoms, in order to address an urgent cancer epidemiology issue in Taiwan.

Detailed description: Cancer of the oral cavity is one of the fastest growing cancers among men in Taiwan. Previous research has established a strong link between betel quid chewing, a common practice among Taiwanese men, and oral cancer. However, despite the strong association, no attempt has been made to develop behavioral measures to facilitate betel quid cessation. This application extends upon existing collaboration between MD Anderson and China Medical University Hospital (CMUH) and seeks to characterize betel quid chewers and their withdrawal symptoms, in order to address an urgent cancer epidemiology issue in Taiwan. In a two phase study, we will use a qualitative approach (guided focus group and interviews), followed by assessment of betel quid withdrawal in current chewers: 1) 47 participants will be invited to participate in a qualitative study that includes focus group and in-depth structured interviews that examine the social and cultural context that surrounds continued use and cessation of betel quid consumption, 2) 30 male and female healthy individuals who currently both chew betel quid and smoke cigarettes will be invited to attend 4 separate sessions at CMUH and complete a self-report questionnaire specifically designed to measure betel quid withdrawal symptoms, and the relationship between betel quid chewing and cigarette smoking withdrawal. This application represents the first step in the development of a multi-phase, multidisciplinary betel quid chewing research program. This program will enhance our understanding of the cultural and bio-behavioral aspects of betel quid chewing. Furthermore, it will lead to translational research projects that link behavioral findings to clinical treatments, and the eventual creation of a large scale, population-based prevention and education program.

Eligibility criteria: Inclusion Criteria:

* Smoking and betel nut chewing habit and at least 20 years old to 65 years old and healthy people.

Exclusion Criteria:

* 1. Less than 20 years old or greater than 65 years.
* 2. No smoking and betel nut chewing habit.

Primary outcomes:
measure: Predictive validity of a self-reported measure of areca nut dependency scale.
timeFrame: up to 28days
Secondary outcomes:
measure: Develop a self-report questionnaire that examines betel quid withdrawal
timeFrame: focus group each lasts for about 60 to 90 minutes and one-to-one interviews each lasts for about 45 to 60 minutes.
Other outcomes:
Locations:
city: Taichung
country: Taiwan
facility: China Medical University Hospital
Study officials:
References: