Biobehavioral and Cultural Determinants of Betel Quid Chewing, Dependence, and Withdrawal in Taiwan

Smoking Clinical Trial

— BCDBQCDWT  

Official title:

Biobehavioral and Cultural Determinants of Betel Quid Chewing, Dependence, and Withdrawal in Taiwan

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02167295
• Other study ID #: DMR101-IRB1-258(CR-2)
• Status: Completed
• Phase: N/A
• First received: February 26, 2013
• Last updated: December 13, 2015
• Start date: December 2012
• Est. completion date: April 2015

Study information

• Verified date: December 2015
• Source: China Medical University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 77
• Est. completion date: April 2015
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Betel Nut
• Smoking

Locations

Country	Name	City	State
Taiwan	China Medical University Hospital	Taichung

Sponsors (2)

Lead Sponsor	Collaborator
China Medical University Hospital	M.D. Anderson Cancer Center

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive validity of a self-reported measure of areca nut dependency scale.		up to 28days
Secondary	Develop a self-report questionnaire that examines betel quid withdrawal	To know reasons for betel quid chewing or for quitting, pros and cons of betel quid chewing, barriers to and facilitators of abstinence, health beliefs and experiences about betel quid chewing and other issues.And then, we propose to develop a self-report questionnaire that examines betel quid withdrawal among Taiwanese chewers who are also current cigarette smokers.	focus group each lasts for about 60 to 90 minutes and one-to-one interviews each lasts for about 45 to 60 minutes.