Workplace Tobacco Cessation And Oral Cancer Screening Study
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ClinicalTrials.gov Identifier: NCT00750503 |
Recruitment Status :
Completed
First Posted : September 10, 2008
Last Update Posted : September 10, 2008
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Tracking Information | |||
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First Submitted Date ICMJE | September 9, 2008 | ||
First Posted Date ICMJE | September 10, 2008 | ||
Last Update Posted Date | September 10, 2008 | ||
Study Start Date ICMJE | June 2007 | ||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | ||
Current Primary Outcome Measures ICMJE |
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 ] | ||
Original Primary Outcome Measures ICMJE | Same as current | ||
Change History | No Changes Posted | ||
Current Secondary Outcome Measures ICMJE |
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 ] | ||
Original Secondary Outcome Measures ICMJE | Same as current | ||
Current Other Pre-specified Outcome Measures | Not Provided | ||
Original Other Pre-specified Outcome Measures | Not Provided | ||
Descriptive Information | |||
Brief Title ICMJE | Workplace Tobacco Cessation And Oral Cancer Screening Study | ||
Official Title ICMJE | 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. |
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Study Type ICMJE | Interventional | ||
Study Phase ICMJE | Phase 3 | ||
Study Design ICMJE | Allocation: N/A Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE | Behavioral: Behavioural and Pharmacotherapy for tobacco cessation
Professional help in the form of health awareness sessions, focus group discussion, one to one counseling and pharmacotherapy was provided to the employees by a team of doctors and counselors from Tata Memorial Hospital. Self reporting of tobacco history was validated with Rapid Urine cotinine test. Naked eye examination of oral cavity of all employees for detection of oral pre-cancers and cancers was conducted. Nursing staff and Doctors attached to the industry and from the local referral hospital were invited to participate as trainees during the active intervention sessions for local manpower development.
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Study Arms ICMJE | Not Provided | ||
Publications * | Not Provided | ||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||
Recruitment Status ICMJE | Completed | ||
Actual Enrollment ICMJE |
104 | ||
Original Actual Enrollment ICMJE | Same as current | ||
Actual Study Completion Date ICMJE | August 2008 | ||
Actual Primary Completion Date | June 2008 (Final data collection date for primary outcome measure) | ||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years to 60 Years (Adult) | ||
Accepts Healthy Volunteers ICMJE | Yes | ||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||
Listed Location Countries ICMJE | India | ||
Removed Location Countries | |||
Administrative Information | |||
NCT Number ICMJE | NCT00750503 | ||
Other Study ID Numbers ICMJE | 458 | ||
Has Data Monitoring Committee | Yes | ||
U.S. FDA-regulated Product | Not Provided | ||
IPD Sharing Statement ICMJE | Not Provided | ||
Responsible Party | Dr. Gauravi Ashish Mishra, Assistant Professor and Assistant Physician, Tata Memorial Hospital | ||
Study Sponsor ICMJE | Tata Memorial Hospital | ||
Collaborators ICMJE | Department of Atomic Energy | ||
Investigators ICMJE | Not Provided | ||
PRS Account | Tata Memorial Hospital | ||
Verification Date | August 2008 | ||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |