- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00750503
Workplace Tobacco Cessation And Oral Cancer Screening Study
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
Maharashtra
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Tal. Khed, District : Ratnagiri, Maharashtra, India
- Chemical Industry
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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.
Time Frame: 12 months
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The prevalence of oral precancerous and cancerous lesions among this group and its correlation with the different forms and frequency of tobacco use.
Time Frame: 12 months
|
12 months
|
Collaborators and Investigators
Sponsor
Collaborators
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 458
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