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Trial record 21 of 11741 for:    Oral Cancer

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
Sponsor:
Collaborator:
Department of Atomic Energy
Information provided by:
Tata Memorial Hospital

Tracking Information
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
 (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  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (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  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Tobacco Cessation
  • Oral Cancer
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.
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.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 9, 2008)
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:

  • 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  ICMJE
Sexes Eligible for Study: Male
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