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Workplace Tobacco Cessation And Oral Cancer Screening Study

Primary Purpose

Tobacco Cessation, Oral Cancer

Status
Completed
Phase
Phase 3
Locations
India
Study Type
Interventional
Intervention
Behavioural and Pharmacotherapy for tobacco cessation
Sponsored by
Tata Memorial Hospital
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tobacco Cessation focused on measuring tobacco cessation, behavioral therapy, pharmacotherapy, workplace, oral cancer screening, Tobacco Quit rates

Eligibility Criteria

18 Years - 60 Years (Adult)MaleAccepts Healthy Volunteers

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.

Sites / Locations

  • Chemical Industry

Outcomes

Primary Outcome Measures

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 Measures

The prevalence of oral precancerous and cancerous lesions among this group and its correlation with the different forms and frequency of tobacco use.

Full Information

First Posted
September 9, 2008
Last Updated
September 9, 2008
Sponsor
Tata Memorial Hospital
Collaborators
Department of Atomic Energy
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1. Study Identification

Unique Protocol Identification Number
NCT00750503
Brief Title
Workplace Tobacco Cessation And Oral Cancer Screening Study
Official Title
Workplace Tobacco Cessation And Oral Cancer Screening Study
Study Type
Interventional

2. Study Status

Record Verification Date
August 2008
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
June 2008 (Actual)
Study Completion Date
August 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Tata Memorial Hospital
Collaborators
Department of Atomic Energy

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tobacco Cessation, Oral Cancer
Keywords
tobacco cessation, behavioral therapy, pharmacotherapy, workplace, oral cancer screening, Tobacco Quit rates

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
104 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Behavioral
Intervention Name(s)
Behavioural and Pharmacotherapy for tobacco cessation
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Secondary Outcome Measure Information:
Title
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

10. Eligibility

Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Facility Information:
Facility Name
Chemical Industry
City
Tal. Khed, District : Ratnagiri
State/Province
Maharashtra
Country
India

12. IPD Sharing Statement

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Workplace Tobacco Cessation And Oral Cancer Screening Study

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