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A SMOKELESS TOBACCO AWARENESS PROGRAM was conducted for 2 consecutive weeks in all the selected schools. The intervention programme comprised of health education sessions that emphasized on the hazard of betel quid, areca-nut and smokeless tobacco. The sessions included 30 minutes power point presentation, posters, one pictorial booklets on the hazards of use of various tobacco products. Moreover we played a 30 minutes game show at follow-up visit. After completion of 2 weeks intervention programme, the same group of students completed the post-test questionnaire. Educational materials about hazards of betel quid, areca-nut and smokeless tobacco were distributed to both intervention and control groups.

No specific education will be given to the control group.

SMOKELESS TOBACCO AWARENESS PROGRAM

Zahid Butt, PhD

Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the eighth most common cancer worldwide.The annual estimated incidence is around 275,000 for oral and 130,300 for pharyngeal cancers excluding nasopharynx, two-thirds of these cases occurring in developing countries. In Pakistan, it is the second most common cancer in women and third most common cancer in men. The Age Standardized Rates (ASR) for oral cancers are 13.8 and 14.1 in males and females respectively.To the best of investigators knowledge, no intervention study has been done to improve knowledge and awareness of adults regarding association of areca nut/betel quid with oral cancer. Therefore, the study aims to implement a cluster randomized intervention trial in secondary schools to improve the knowledge and awareness regarding this association among children 11-16 years. For resource poor countries such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its important risk factor such as betel quid, areca nut and chew tobacco. A school-based intervention study will be carried out in secondary schools in Karachi. The target population will be male and female school students in school grades 6 to 10 with intervention group and control group at each site. School-based educational intervention will be given to the intervention group while no specific education will be given to the control group. Differences in attitudes, knowledge and behaviors between the intervention and control groups will be compared each site separately before and after the intervention. The minimum sample size required was 22 schools (clusters). The number of subjects in each arm will be 529 with average cluster size of 50. The selected schools will be randomly assigned to a control group or Interventions group. Randomization will be done at the school level to avoid contamination between groups.The health education programme will be conducted for 3 consecutive weeks in one academic year for all the selected schools.

Oral cancer is a serious and growing problem in many parts of the globe. Oral cancer is the eighth most common cancer worldwide. There is a wide geographical variation (approximately 20-fold) in the incidence of this cancer. In South and South East Asia, 40% of the people with cancers have been diagnosed with it. Age-adjusted rates of oral cancer in India is high, that is, 20 per 100,000 population and accounts for over 30% of all cancers in the country. In Pakistan, it is the second most common cancer in women and third most common cancer in men.The Age Standardized Rates (ASR) for oral cancers are 13.8 and 14.1 in males and females respectively. Smoking, alcohol consumption and sunlight have been implicated in the development of oral cancers in the developed countries. In addition to these, developing countries have their own set of risk factors.These include poor infrastructure of the health care system, illiteracy, poor socioeconomic status. A common risk factor shared by populations from all over the world is substance abuse.There exists a large volume of literature which links betel nut, areca, chewable tobacco and tobacco with development of cancer.

A study from South Asia have reported the risk of oral cancer and the use of oral tobacco in various forms including ''paan'' with and without tobacco. A case-control study from Thailand reported that, among all components of the betel quid, the presence in the quid of red slaked lime had the strongest effect on the risk of oral cancer (OR,10.67; 95% CI = 2.27-50.08). A recently published meta-analysis also explores the relationship between betel quid chewing and risk of oral and oropharyngeal cancers.

Oral diseases are a major global health burden despite considerable investment in research and dental services. A meta-analysis of fifteen case control studies (4,648 cases; 7,847 controls) has shown betel quid to have an independent positive association with oral cancer, with OR = 2.82 (95% CI = 2.35-3.40). Studies conducted in Pakistan report about knowledge, perception and correlation of betel quid and head and neck cancer.

The study aims to implement a cluster randomized intervention trial in secondary schools to improve the knowledge and awareness regarding this association among children 6-10 years. For resource poor countries such as Pakistan, it is imperative to prevent oral cancer by improving knowledge about its important risk factor such as betel quid, areca nut and chew tobacco.

Methods:

Study Design and Setting:

A school-based intervention study will be carried out in secondary schools in Karachi. The target population will be male and female school students in school grades 6 to 10 with intervention group and control group at each site.

Sample Size:

Sample size was calculated using the computer program WHO ACluster. The minimum sample size required is 22 schools (clusters) with 95% confidence interval, 80% power, and ICC= 0.2. The difference to be detected was 2 with standard deviation 9.5. The number of subjects in each arm will be 529 with average cluster size of 50.

Sampling:

A two-stage cluster sampling with stratification based on school type (government or private) will be employed. A multistage cluster sampling with stratification on school type (government or private) will be employed for the selection of schools and recruitment of adolescents. After stratification schools will be selected randomly proportionate to the number of type of school from district east of Karachi. Each school will be considered as a cluster. Schools will be the primary unit of randomization. Recruitment of participating schools will be based on the willingness to participate in the study. One class will be selected randomly from each of selected secondary (grades 6-10) schools and all the students in the selected classes will be invited to participate in the survey. Hence, equal number of clusters will be selected in both groups.

Randomization:

The selected schools will be randomly assigned to a control group or Interventions group. Randomization will be done at the school level to avoid contamination between groups.

Study procedure:

Approval for the design and data collection procedures was obtained beforehand from the ethics committee of the School. An approval was obtained from school authority after explaining the purpose of the study. Written informed consent was taken from all participating schools and it will be communicated to the students that participation is completely voluntary. Absolute confidentiality of the data will be maintained throughout the study.

School-based educational intervention will be given to the intervention group while no specific education will be given to the control group. Pre and post-test questionnaires will be administered one week before and one week after the program intervention, respectively. Tests will be administered in the students' usual classroom by research assistants under the supervision of the researchers who are not affiliated with the schools.

Intervention Programme:

The health education programme will be conducted for 2 consecutive weeks in one academic year for all the selected schools. The intervention programme will comprise of health education sessions that will emphasize on the hazard of betel quid and areca nut and chew tobacco. This will be conducted through posters, pictorial booklets, video shows, and short documentaries on the hazards of use of various tobacco products. The programme will be conducted by a trained team. Educational materials about hazards of betel quid and areca nut will be distributed to both intervention and control groups.

Training sessions:

The programme will be conducted by a professional team of physicians trained in this field. A one-day training session for the program providers will be designed to maximize the success of the program implementation.

Plan of Analysis:

Investigators will perform analysis using STATA version 12. Descriptive statistics will be computed for categorical variables by computing their frequencies \& assessed by chi square. The distribution of quantitative variables will be computed by their means and standard deviations \& assessed by independent t test or median with inter-quartile range (IQR) depending on distribution of the variables. Investigators will perform multivariable analysis using generalizing estimating equation (GEE) to consider the clustering structure of the data. Crude odds ratio (OR) and their 95% confidence interval (CI) will be calculated using univariate GEE. All the variables with a p-value of less than 25% significance will be selected for inclusion in the multivariable analysis.

Confounding will be assessed by change in estimate of coefficient by 15%. After developing main effect model, significance of all biologically plausible interactions will be evaluated for inclusion in multivariable model.

Interim analysis:

Interim analysis will be conducted, if required, after completion of 50% of the follow-ups to see the effect of educational intervention programme on the participant's knowledge.

Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco

Knowledge and Awareness Regarding Association of Arecanut/Betel Quid and With Oral Cancer and Other Serious Illnesses Among Children 11-16 Years; A Cluster Randomized Intervention Study

It will depend on the requirement of the journal

Knowledge about hazards of smokeless tobacco will be measured by a validated questionnaire from male and female school students studying in grades 6 to 10.

Attitude about hazards of smokeless tobacco will be measured by a validated questionnaire from male and female school students studying in grades 6 to 10.

Perception about hazards of smokeless tobacco will be measured by a validated questionnaire from male and female school students studying in grades 6 to 10.

Dow University of Health Sciences

Aga Khan University

Assistant Professor

Students in the control group will receive the standard health education curriculum.

Students in the treatment group will receive the school-based classroom curriculum.

Participants will be randomized, at the school level, to receive either the e-cigarette/tobacco/areca nut use prevention curriculum or the standard of care (i.e., control). The curriculum will be implemented using 5 intensive in-class lessons over the span of 6 weeks. All sessions of the curriculum follow the same basic format: a) an introduction and/or review of the past lesson, b) a cultural wall activity, c) a video, d) 1-2 interactive activities, and e) a wrap-up activity. Lessons are designed such as to help improve knowledge about drugs and correct cognitive misperceptions and to train on skills to resist normative social influence. Participants will complete identical survey questionnaires for assessments at 3 time-points: pretest (baseline, before implementing the intervention), immediate posttest (following the end of the intervention), and six-month follow-up. The surveys will be administered in the classroom, during regular school hours.

School-based curriculum

Francis Dalisay, PhD

Pallav Pohkrel, PhD

The people of the U.S. Affiliated Pacific Islands (USAPI) face higher cancer incidence, especially lung/bronchia and head-and-neck cancer, and poorer cancer outcomes, compared with the U.S. nationally. This may partly be driven by the high rates of cigarette smoking and betel (areca) nut use in the USAPI. Previous data suggest that that adolescents on Guam, as young as middle school students report markedly higher e-cigarette and tobacco product use prevalence in the USAPI compared with the USAPI nationally. Guam youths are also at risk for the use of betel nuts. Yet, currently there are no tobacco product/areca nut use prevention programs that have been developed for and tested specifically USAPI adolescents. The proposed study will develop a school-based substance use prevention curriculum for e-cigarette, tobacco product, and areca nut use prevention among Guam youths. The curriculum will use lessons incorporating innovative videos and culturally grounded activities.

The study's specific aims are:

1. To develop a school-based curriculum for e-cigarette, tobacco product (i.e., cigarette, smokeless tobacco), and betel nut use prevention among middle school students in Guam.
2. Test the efficacy of the school-based curriculum in a randomized controlled trial.

BACKGROUND AND SIGNIFICANCE

The study focuses on e-cigarette, tobacco and areca nut prevention among adolescents in Guam. By developing and testing a school-based e-cigarette, tobacco and areca nut prevention program, the project will target psychosocial, lifestyle, and environmental/physical factors contributing to cancer disparities in the US Affiliated Pacific Islands (USAPI). Thus far, nationally, there has been limited effort in terms of developing a theoretical framework that would attempt to explain tobacco and areca nut use etiology among USAPI youth. Previous research indicates that social and environmental influences play key roles in shaping tobacco and areca nut use among USAPI youths. In addition, skills needed to resist social influence appear to be protective against tobacco and areca nut use. Particularly, past research has found peer influence and environmental risk factors such as parental permissiveness, ease of access to tobacco/areca nut at home and school and through adults and friends, to be strongly associated with current tobacco/areca nut use. On the other hand, competence in navigating through social situations conducive to tobacco/areca nut use and refusal self-efficacy (i.e., confidence in being able to say "no" at the face of peer pressure) have been found to be strongly associated with lower likelihood of current tobacco/areca nut use.

The curriculum to be developed and tested will focus on informing adolescents on the risks of tobacco product/areca nut use as well as training adolescents on social influence resistance skills in a culturally appropriate way, using innovative use of video vignettes. The intervention will seek to influence behavior (i.e., prevention and reduction of tobacco product/areca nut use) by countering the cognitive predispositions to tobacco product/areca nut use (e.g., by increasing risk perceptions, reducing positive expectancies) and by providing youths with skills to resist specific social influence to use tobacco products/areca nut on specific occasions.

RESEARCH DESIGN

This is an experimental study. Of the eight public middle schools in Guam, four schools will be randomly assigned to the "Treatment" and four to the "Control" condition. Students in the Treatment schools will receive the classroom-based curriculum whereas students in the Control schools will receive the standard health education curriculum (treatment-as-usual). Participants will be assessed at pre-test, immediate post-test, and six months after the post-test. Note that the decision to provide an intervention, albeit weaker, to the control group was guided by the ethics of good community practice. In preliminary discussions with schools, principals unanimously expected an intervention.

Participants

Participants will be 600 Guam middle school students. Based on a pilot study, the mean age of the participants is likely to be 12.7 years (SD = .89); 49% of the participants are likely to be girls; and 47% of the participants are likely to be Chamorus, 27% other Pacific Islanders, and 25% non-Pacific Islanders (i.e., Filipinos, Chinese, Japanese, white, and others). Treatment and Control conditions will represent roughly equal proportion of participants.

Recruitment

All eight public middle schools will be involved in the study. The Guam Department of Education (GDOE) has been very supportive of this study. At each school, seven classes will be randomly selected to participate in the study.

Intervention delivery

The classroom curriculum will begin in the Treatment schools within two weeks of the pre-test. The social media campaign will begin in all schools around the same time. Below we provide details on the delivery of each intervention component.

Classroom-based curriculum: Curriculum implementation. The curriculum will be delivered by teachers of the Treatment schools who normally teach physical health education classes. The curriculum will be implemented once a week for 45-60 minutes over a 10-week academic quarter in a required physical/health education course. All sessions of the curriculum will follow the same basic format of Ho'ouna Pono. Each lesson will be aligned with the Guam Content and Performance Standards for Health (6-8 grade) and/or the National Common Core Standards in public education. The teachers will be trained to implement the curriculum through a hybrid (i.e., in-person and virtual), credit-granting course sanctioned through the GDOE.

Data collection

Data will be collected at three timepoints from students in both Treatment and Control conditions: pre-test (baseline), immediate post-test (i.e., approximately a week after the last classroom-based curriculum session is delivered), and six months after the post-test. Data will be collected using self-report questionnaires, although self-report of cigarette use and areca nut use will also be validated using biochemical verification methods in random subsample of participants. At each timepoint the same questionnaire will be administered across Treatment and Control groups. The self-report questionnaire will include the following assessment measures.

Measures

Demographic measures. Age, gender, socio-economic status, and ethnicity will be assessed. Socio-economic status (SES) is measured based on participants' report on their parents' level of education. However, past research shows that a good proportion of adolescents do not know about parental education level. Hence, a measure of household crowdedness (i.e., the number of usual residents in a household divided by the number of rooms in the house) will also be included to assess SES. Ethnicity will be assessed with a single item previously used by us in Guam. A measure of acculturation will also be included.

Intrapersonal/Dispositional variables. These will include self-control, assessed in terms of behavioral and emotional self-control; sensation seeking; social competence in resisting social influence; general self-efficacy; refusal self-efficacy; and self-esteem. The items specific to substance use will be adapted for cigarette smoking, e-cigarette use, chewing tobacco use, and areca nut use.

Social/Interpersonal variables. These will include family and friend areca nut/tobacco product use, perceived norms, and social normative beliefs. Perceived norms and social normative beliefs will be adapted for cigarette smoking, e-cigarette use, chewing tobacco use, and areca nut use.

Cultural/Environmental variables. These will include availability of areca nut/tobacco at home and school, parental permissiveness, knowledge about areca nut/tobacco products, areca nut/tobacco product use expectancies, and areca nut/tobacco product use harm/risk perceptions.

Exposure to content relevant to tobacco products and areca nut on social media. Exposure will be assessed using 12 items previously validated by us for tobacco products and areca nut. The items assess exposure to user-generated content, traditional marketing, and prevention messages.

Areca nut and tobacco product use susceptibility. Areca nut use and tobacco product use susceptibility will be separately assessed for cigarette smoking, e-cigarette use, chewing tobacco use, and areca nut use with a measure of adolescent substance use intentions (13), adapted for each substance.

Areca nut and tobacco product use. The study will assess areca nut only use, combined areca nut and tobacco use, cigarette smoking, e-cigarette use, and chewing tobacco use separately. For each of these substance use outcomes, the study will assess lifetime (ever) use (e.g., "Have you ever used a areca nut in your lifetime?") and past-30-day use (e.g., "In the past 30 days, on how many days did you use areca nut?). Self-report measures of adolescent substance use have been extensively studied for their validity, by using multiple methods, and they have consistently been found to be valid.

Data Analysis

Data analysis will be performed with the help of the PIPCHE Biostatistics Core. The primary goal of the analysis is to examine the efficacy of this group randomized trial (16) for substance use prevention among middle schoolers. Aim 1 will compare the change in tobacco and areca nut beliefs, attitudes, initiation and use over time between the two randomization conditions, accounting for the clustering of classes within schools and the randomization unit of schools. In particular, the following mixed regression will be performed: where Z is a vector of covariates for each student at each time point, T is time, G is randomization group, TxG is the interaction of time and group, and η is a random effect for clustering of classes within schools and δ is a random effect for repeated measures within student. The link function ƒ is linear for continuous outcomes, such as a belief score, and logistic for dichotomous outcomes, such as initiation; outcomes will be transformed as needed to meet model assumptions. Potential covariates would include age, sex of student, grade, ethnicity, parent's education level, sensation seeking and teacher sex. Time T will be parameterized as indicator variables for baseline, post-intervention, and six month follow-up, or as continuous months if warranted by a monotonic change over time. The intervention effect will be assessed by the F-test in linear models and chi-square test in logistic models for the βTG parameter, with the degrees of freedom adjusted to account for the eight randomization units. Covariate-adjusted means and 95% confidence intervals will be estimated from the models for each level of randomization group and time point. The SAS procedure GLIMMIX will be used to fit these mixed models, which can accommodate data from students with missing data at some time points and allow for the results to be more generalizable to the student population. However, the study will assess the effect of missing data by comparing characteristics of students with complete and incomplete data and will perform multiple imputation if needed. As exploratory analyses, the study will test for differential intervention effects in subgroups, such as defined by student ethnicity, by adding interaction terms between subgroup and treatment/time variables and assessing the significance of the three way interaction. The study will also explore the effect of dose of the intervention, by studying change in outcomes by number of session attended among students in the intervention schools, and the effect of fidelity assessments of the intervention per classroom.

Statistical Power

The sample size of eight schools, with four randomized to each condition, each with seven classes of 20 students, is sufficient to ensure adequate statistical power to detect meaningful differences between intervention arms in all outcomes. For Aim 1, the effect size, Cohen's d was calculated based on a z-test comparing means and a chi-square test comparing proportions, with n=8 schools, with four schools per randomization condition, each with 20 students. The variance of the differences was adjusted for the Design Effect of the present study, accounting for the clustering in a group-randomized trial (GRT) by adjusting the test degrees of freedom to the number of communities. The intraclass correlation coefficient (ICC) of outcomes within schools and within class in schools was set to 0.01-0.02, based on past school-based studies, for an overall ICC varying between 0.02 to 0.04. The study assumed a critical level α of 0.05 (two-sided) or 0.005 (Bonferroni-corrected for 10 tests), a power of 80%, and up to a 20% attrition in sample size at post-intervention. The effect size for a test of means is medium at 0.29-0.38 for α=0.05 and at 0.37-0.50 for α=0.005. The following differences between conditions in changes in proportions will be detectable with α=0.05: 0% versus 4.0% and 3% versus 10.5%; and with α=0.005: 0% versus 6.5% and 3% versus 15.5%.

Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths

University of Guam/University of Hawaii Cancer Center Partnership for Cancer Health Equity, Full Project I: Developing and Testing a School-Based Curriculum for E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention for Guam Youths

Tobacco, e-cigarette, and areca nut use behavior will be assessed using a standardized self-report measure of recent use that is use in the national YRBS survey. The questionnaire item will ask: "In the past 30 days, on how many days did you smoke a cigarette?" This question will be adapted for e-cigarette and areca nut. Response options include: "0 days," "1-2 days," "3-5 days," "6-9 days," "10-19 days," "20-29 days," "all 30 days."

This is a standardized self-report measure containing 4 items originally designed to assess smoking susceptibility among adolescents. In addition to the original measure, the current study will also adapt the measure to assess e-cigarette and areca nut use susceptibility. The 4 items are: "Do you think you will smoke a cigarette soon?", "Do you think you will smoke a cigarette in the next year?", "Do you think in the future you might experiment with cigarettes?", "If one of you friends were to offer you a cigarette, would you smoke it?"

This is a standardized self-report scale containing 7 items designed to assess generalized self-control, including impulsivity and behavioral self-control.

This is a standardized self-report scale containing 27 items designed to assess social competence is resisting social influence related to tobacco and other substance use among adolescents.

This is a standardized self-report scale containing 6 items designed to assess confidence in performing a behavior. Sample items include "When I make plans, I am certain I can make them work", "If I can't do a job the first time, I keep trying until I can", and "When I have something unpleasant to do, I stick to it until I finish it".

This is a standardized self-report scale containing 6 items designed to assess confidence in refusing tobacco and other substance use offers.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco	NCT03418506	Smokeless Tobac...	SMOKELESS TOBAC...	11 Years - 16 Years	Aga Khan University
Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco	NCT03418506	Smokeless Tobac...	SMOKELESS TOBAC...	11 Years - 16 Years	Aga Khan University
Testing a School-Based E-cigarette, Tobacco, and Betel (Areca) Nut Use Prevention Curriculum for Guam Youths	NCT05037656	Tobacco Smoking Vaping Tobacco Chewing	School-based cu...	11 Years - 15 Years	University of Guam

Spots Global Cancer Trial Database for areca nut

Every month we try and update this database with for areca nut cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for areca nut

Every month we try and update this database with for areca nut cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for areca nut cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.