Workplace Tobacco Cessation And Oral Cancer Screening Study
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tobacco Cessation Oral Cancer |
Behavioral: Behavioural and Pharmacotherapy for tobacco cessation |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Workplace Tobacco Cessation And Oral Cancer Screening Study |
- 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 ] [ Designated as safety issue: No ]
- 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 ] [ Designated as safety issue: No ]
| Enrollment: | 104 |
| Study Start Date: | June 2007 |
| Study Completion Date: | August 2008 |
| Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
-
Behavioral: Behavioural and Pharmacotherapy for tobacco cessation
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.
Eligibility| Ages Eligible for Study: | 18 Years to 60 Years |
| Genders Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
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.
Contacts and Locations
More Information
No publications provided
| Responsible Party: | Dr. Gauravi Ashish Mishra, Assistant Professor and Assistant Physician, Tata Memorial Hospital |
| ClinicalTrials.gov Identifier: | NCT00750503 History of Changes |
| Other Study ID Numbers: | 458 |
| Study First Received: | September 9, 2008 |
| Last Updated: | September 9, 2008 |
| Health Authority: | India: Indian Council of Medical Research |
Keywords provided by Tata Memorial Hospital:
|
tobacco cessation behavioral therapy pharmacotherapy |
workplace oral cancer screening Tobacco Quit rates |
Additional relevant MeSH terms:
|
Mouth Neoplasms Lip Neoplasms Head and Neck Neoplasms Neoplasms by Site |
Neoplasms Mouth Diseases Stomatognathic Diseases Lip Diseases |
ClinicalTrials.gov processed this record on May 19, 2013