Workplace Tobacco Cessation And Oral Cancer Screening Study

This study has been completed.
Sponsor:
Collaborator:
Department of Atomic Energy
Information provided by:
Tata Memorial Hospital
ClinicalTrials.gov Identifier:
NCT00750503
First received: September 9, 2008
Last updated: NA
Last verified: August 2008
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Tata Memorial Hospital:

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. [ Time Frame: 12 months ] [ Designated as safety issue: No ]

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. [ 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)
Intervention Details:
    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.
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.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00750503

Locations
India
Chemical Industry
Tal. Khed, District : Ratnagiri, Maharashtra, India
Sponsors and Collaborators
Tata Memorial Hospital
Department of Atomic Energy
  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 September 16, 2014