SmokingBCDBQCDWTNCT02167295
Biobehavioral and Cultural Determinants of Betel Quid Chewing, Dependence, and Withdrawal in Taiwan
An observational study of Smoking and Betel Nut, run by China Medical University Hospital at 1 site in Taiwan.
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. Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- How many people
- 77 participants
- Where
- 1 siteTaiwan
- Study dates
- Dec 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- Smoking and betel nut chewing habit and at least 20 years old to 65 years old and healthy people.
Who cannot join
- 1. Less than 20 years old or greater than 65 years.
- 2. No smoking and betel nut chewing habit.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Keywords
- betel nut, dependence, withdraw, deprivation test
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Focus group | The focus groups will consist of 6 to 8 persons each (N = 32). The focus group discussions will last for about 60 to 90 minutes. The discussion topics will be based on previous literature and experience and will include 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. | |
| In-depth interviews. | We will conduct 15 one-to-one interviews, each lasts for about 45 to 60 minutes. Participants will be interviewed by a trained interviewer using a structured interview. The interview will be designed to collect information on socio-demographic background, current and/or former betel quid use, other substance use (smoking and/or alcohol consumption), as well as other variables including usage parameters, psychosocial and environmental influences on betel quid chewing, barriers to and interest in quitting, and knowledge of adverse effects on health. | |
| Self-report questionnaire | This study is expected to enroll 30 participants who have smoking and betel nut chewing behaviors.Participants will complete 4 separate visits to CMUH, during which they will complete the same self-report questionnaire designed to measure withdrawal symptoms relating to betel quid chewing. To better measure betel quid withdrawal symptoms and to distinguish the 6 symptoms from those of smoking withdrawal, Participants will be required to attend one visit regular cigarette smoking and betel nut chewing behavior without restriction (as control), one visit after 12 hours of overnight betel quid deprivation (no cigarette deprivation), one visit after 12 hours of overnight cigarette deprivation (no betel quid deprivation), and one visit after 12 hours of both overnight betel quid and cigarette deprivation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Predictive validity of a self-reported measure of areca nut dependency scale.
Measured: up to 28days
Secondary outcomes (1)
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.
Measured: focus group each lasts for about 60 to 90 minutes and one-to-one interviews each lasts for about 45 to 60 minutes.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jun 2014 (estimated)
- Study startDec 2012
- Primary completionDec 2014
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by China Medical University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Cross-sectional
- Enrolment
- 77 participants (actual)
Sponsor and investigators
- Lead sponsor
- China Medical University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Responsible party
- Principal investigator, Cheng-Chieh Lin, China Medical University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02167295
- Sponsor's protocol ID
- DMR101-IRB1-258(CR-2)
- Acronym
- BCDBQCDWT
- Status last verified
- Dec 2015
- First submitted
- 26 Feb 2013
- Last updated
- 15 Dec 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biobehavioral and Cultural Determinants of Betel Quid Chewing, Dependence, and Withdrawal in Taiwan
- ClinicalTrials.gov ID
- NCT02167295
- Acronym / sponsor ID
- BCDBQCDWT / DMR101-IRB1-258(CR-2)
- Keywords
- betel nut, dependence, withdraw, deprivation test
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 77 participants (actual)
- Lead sponsor
- China Medical University HospitalUniversity, hospital or other
- Collaborators
- M.D. Anderson Cancer Center
- Study start
- Dec 2012
- Primary completion
- Dec 2014 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 19 Jun 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Focus group | – | –The focus groups will consist of 6 to 8 persons each (N = 32). The focus group discussions will last for about 60 to 90 minutes. The discussion topics will be based on previous literature and experience and will include 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. |
| In-depth interviews. | – | –We will conduct 15 one-to-one interviews, each lasts for about 45 to 60 minutes. Participants will be interviewed by a trained interviewer using a structured interview. The interview will be designed to collect information on socio-demographic background, current and/or former betel quid use, other substance use (smoking and/or alcohol consumption), as well as other variables including usage parameters, psychosocial and environmental influences on betel quid chewing, barriers to and interest in quitting, and knowledge of adverse effects on health. |
| Self-report questionnaire | – | –This study is expected to enroll 30 participants who have smoking and betel nut chewing behaviors.Participants will complete 4 separate visits to CMUH, during which they will complete the same self-report questionnaire designed to measure withdrawal symptoms relating to betel quid chewing. To better measure betel quid withdrawal symptoms and to distinguish the 6 symptoms from those of smoking withdrawal, Participants will be required to attend one visit regular cigarette smoking and betel nut chewing behavior without restriction (as control), one visit after 12 hours of overnight betel quid deprivation (no cigarette deprivation), one visit after 12 hours of overnight cigarette deprivation (no betel quid deprivation), and one visit after 12 hours of both overnight betel quid and cigarette deprivation. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Smoking and betel nut chewing habit and at least 20 years old to 65 years old and healthy people.
Key exclusion criteria (2 listed)
- 1. Less than 20 years old or greater than 65 years.
- 2. No smoking and betel nut chewing habit.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Predictive validity of a self-reported measure of areca nut dependency scale.
Time frame: up to 28days
1 secondary outcome
Develop a self-report questionnaire that examines betel quid withdrawal
Time frame: focus group each lasts for about 60 to 90 minutes and one-to-one interviews each lasts for about 45 to 60 minutes.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Smoking and Betel Nut, run by China Medical University Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Predictive validity of a self-reported measure of areca nut dependency scale. (time frame: up to 28days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2015.