Improvement in Knowledge and Perception About Hazards of Smokeless Tobacco
Condition: Smokeless Tobacco Cessation
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): SMOKELESS TOBACCO AWARENESS PROGRAM
Intervention type(s): Behavioral
Intervention description(s): 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.
Intervention MeSH terms: Lobeline
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Other
Keywords: Smokeless tobacco; adolescent; oral cancer; betal quid; areca nut