Please select the eligibility criteria that correspond to the clinical trial below.
Title: 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
Brief 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.


Options:
A: Inclusion Criteria:

* 7th grade students in the 12 enrolled schools during the years their school is randomized to one of these cohorts are eligible to participate
* Parents/caregivers of enrolled middle school students

Exclusion Criteria:

* Data from students with major cognitive disabilities that could compromise self-report behavioral data quality will be excluded
B: Inclusion Criteria:

* Inclusion criteria for cluster/school

  * High schools registered with Board of Secondary Education Karachi
  * The schools should have at least 15 students in each grade.
  * School authorities grant permission to conduct the research study in their school.

Inclusion criteria (For individual)

* Both Male/ female students from grades 6-10.
* Resident of selected areas where the schools are located for at least one year.

Exclusion Criteria:

-
C: Inclusion Criteria:

* • Any student studying the first academic year of secondary school (Enseñanza Secundaria Obligatoria, ESO) in the selected high schools.

Exclusion Criteria:

* No exclusion criteria.
D: Inclusion Criteria:

* Middle school student body is at least 50% minority (defined as African American, Hispanic/Latino, and/or Native American) and/or greater than 50% eligible for free or reduced lunch.
* Middle school annual school-wide attrition from all causes is \<= 25% (estimate determined from data provided by the school).
* Middle school expected cohort size at end of study is at least 50 per school determined by applying 50% anticipated enrollment rate and annual school-wide attrition rate over 3 years.
* Student able to participate in the school's standard PE program.
* Student's parent/guardian has provided informed consent for the child to participate in data collection and evaluation procedures.
* Student has provided informed assent to participate in data collection and evaluation procedures.

Exclusion Criteria: (none specified)

Answer: B