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临床试验/NCT03418506
NCT03418506已完成不适用

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

Aga Khan University1 个研究点 分布在 1 个国家目标入组 1,327 人开始时间: 2017年4月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
1,327
试验地点
1
主要终点
Knowledge about hazards of smokeless tobacco

研究概览

简要总结

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.

详细描述

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:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
11 Years 至 16 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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-
  • Resident of selected areas where the schools are located for at least one year.

排除标准

  • 未提供

研究组 & 干预措施

Intervention

Experimental

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.

干预措施: SMOKELESS TOBACCO AWARENESS PROGRAM (Behavioral)

Control

No Intervention

No specific education will be given to the control group.

结局指标

主要结局

Knowledge about hazards of smokeless tobacco

时间窗: 6 months

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.

次要结局

  • Perception about hazards of smokeless tobacco(6 months)
  • Attitude about hazards of smokeless tobacco(6 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Shafquat Rozi

Assistant Professor

Aga Khan University

研究点 (1)

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