NCT00750503

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
104

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jun 2007

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2007

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2008

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2008

Completed
Last Updated

September 10, 2008

Status Verified

August 1, 2008

Enrollment Period

1 year

First QC Date

September 9, 2008

Last Update Submit

September 9, 2008

Conditions

Tobacco CessationOral Cancer

Keywords

tobacco cessationbehavioral therapypharmacotherapyworkplaceoral cancer screeningTobacco Quit rates

Outcome Measures

Primary Outcomes (1)

  • 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.

    12 months

Secondary Outcomes (1)

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

    12 months

Interventions

Behavioural and Pharmacotherapy for tobacco cessationBEHAVIORAL

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.

Eligibility Criteria

Age18 Years - 60 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • All 104 employees working in the chemical industrial unit at Khed, Ratnagiri, are eligible to participate.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Chemical Industry

Tal. Khed, District : Ratnagiri, Maharashtra, India

Location

MeSH Terms

Conditions

Tobacco Use CessationMouth Neoplasms

Interventions

Drug Therapy

Condition Hierarchy (Ancestors)

Health BehaviorBehaviorHead and Neck NeoplasmsNeoplasms by SiteNeoplasmsMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Design

Study Type
interventional
Phase
phase 3
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV

Study Record Dates

First Submitted

September 9, 2008

First Posted

September 10, 2008

Study Start

June 1, 2007

Primary Completion

June 1, 2008

Study Completion

August 1, 2008

Last Updated

September 10, 2008

Record last verified: 2008-08

Locations

IN(1)