Workplace Tobacco Cessation And Oral Cancer Screening Study

• ClinicalTrials.gov Identifier: NCT00750503
• Recruitment Status: Completed
• First Posted: September 10, 2008
• Last Update Posted: September 10, 2008
• Sponsor: Tata Memorial Hospital
• Collaborator: Department of Atomic Energy
• Information provided by: Tata Memorial Hospital

Tracking Information

• First Submitted Date: September 9, 2008
• First Posted Date: September 10, 2008
• Last Update Posted Date: September 10, 2008
• Study Start Date: June 2007
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: September 9, 2008): 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: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures (submitted: September 9, 2008): 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: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• 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 Type: Interventional
• Study Phase: Phase 3
• Study Design: Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Tobacco Cessation
• Oral Cancer

Intervention

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.

• Study Arms: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 9, 2008): 104
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: August 2008
• Actual Primary Completion Date: June 2008 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 60 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00750503
• Other Study ID Numbers: 458
• Has Data Monitoring Committee: Yes
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Dr. Gauravi Ashish Mishra, Assistant Professor and Assistant Physician, Tata Memorial Hospital
• Study Sponsor: Tata Memorial Hospital
• Collaborators: Department of Atomic Energy
• Investigators: Not Provided
• PRS Account: Tata Memorial Hospital
• Verification Date: August 2008