Brief Title
Workplace Tobacco Cessation And Oral Cancer Screening Study
Official Title
Workplace Tobacco Cessation And Oral Cancer Screening Study
Brief Summary
Tata Memorial Hospital has initiated Workplace Tobacco Cessation and Oral Cancer Screening
Programme in Chemical Industry at Khed, Ratnagiri. Appropriate interventions for tobacco
cessation will be carried at monthly intervals for twelve months duration. The tobacco
cessation rates based on history will be validated with the urinary cotinine levels.
Detailed Description
The prevalence of tobacco use in India among men has been reported to be high in most parts
(generally exceeding 50%). It's use is more common in rural areas as compared to urban areas.
Oral cancer, the main cause of which is tobacco, is common in men in developing countries and
the most common cancer among men in India. The five year survival rate for oral and
pharyngeal cancers even in premier institute like the Tata Memorial Hospital ranges from a
poor 8% (hypo pharynx) to 43% (lower lip). Evidence has shown that cessation is the only
intervention with the potential to reduce tobacco related mortality in the short- term and
medium- term. An emphasis on prevention of tobacco consumption will, in the short run, only
have a limited positive effect on tobacco related morbidity and mortality, as prevention
strategies do not affect existing consumers. Workplace tobacco cessation activities in India
are still in rudimentary stage.
In the proposed study of one year duration, professional help in the form focus group
discussion, one to one counseling and pharmacotherapy will be provided to the employees by a
team of doctors and counsellors from Tata Memorial Hospital. Self reporting of tobacco
history will be validated with Biochemical test. This will add objectivity to the programme,
so that, if successful, it can be replicated as a model to promote tobacco control activities
at other workplaces. Naked eye examination of oral cavity of all employees for detection of
oral pre-cancers and cancers will be done by doctors from the Tata Memorial Hospital. The
employees with lesions may be referred for further management, if required. Nursing staff and
Doctors attached to the industry and from the local referral hospital will be invited to
participate as trainees during the active intervention sessions.
The long term objective of this initiative is to establish a model workplace tobacco
cessation and oral cancer screening programme. It will contribute to the human resource and
infrastructure development for tobacco cessation services at the industrial unit and at the
local referral hospital. Proposed tobacco cessation services in the chemical industry would
be of great help for boosting Anti - Tobacco Activities not only in the particular factory
unit but also in the nearby industrial and residential zone.
Study Phase
Phase 3
Study Type
Interventional
Primary Outcome
The prevalence of tobacco use and the the change in Knowledge, Attitude and Practices during post intervention. The reasons for initiation and continuation of tobacco consumption habit. The tobacco quit rates.
Secondary Outcome
The prevalence of oral precancerous and cancerous lesions among this group and its correlation with the different forms and frequency of tobacco use.
Condition
Tobacco Cessation
Intervention
Behavioural and Pharmacotherapy for tobacco cessation
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
104
Start Date
June 2007
Completion Date
August 2008
Primary Completion Date
June 2008
Eligibility Criteria
Inclusion Criteria:
- All 104 employees working in the chemical industrial unit at Khed, Ratnagiri, are
eligible to participate.
Exclusion Criteria:
- There are no exclusion criteria.
Gender
Male
Ages
18 Years - 60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
, ,
Location Countries
India
Location Countries
India
Administrative Informations
NCT ID
NCT00750503
Organization ID
458
Study Sponsor
Tata Memorial Hospital
Collaborators
Department of Atomic Energy
Study Sponsor
, ,
Verification Date
August 2008