NCT02354638

Brief Summary

In addition to the passengers smoking inside the cab, the taxi drivers,are themselves addicted to smoking and/ or use of smokeless tobacco. Since tobacco is highly addictive, the cab drivers using tobacco need help in quitting. It is also necessary to raise the awareness of the cab drivers with respect to the hazards of tobacco and significance of the smoke free legislation. It's been six years since the implementation of rules prohibiting smoking in public places and a re-look at the compliance to this regulation is necessary. The study will also help tobacco users to quit their habits. They will get screened for oral premalignant and malignant lesions. Also, the cab drivers may pass on some effective messages regarding importance of keeping oneself away from tobacco, to the customers while commuting. In view of the above background, the current study is proposed to look at all these aspects. The findings of the study will be certainly generating useful information with regards to lacunae in the existing system for appropriate implementation and for strengthening anti tobacco advocacy in our country.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
400

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2014

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2014

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

December 11, 2014

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 3, 2015

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

April 30, 2018

Status Verified

April 1, 2018

Enrollment Period

3.3 years

First QC Date

December 11, 2014

Last Update Submit

April 27, 2018

Conditions

Compliance

Keywords

PerceptionsEducation and evaluate post intervention KAP

Outcome Measures

Primary Outcomes (1)

  • Knowledge, Attitude & practice (change in the baseline KAP)

    a) The

    30 months

Secondary Outcomes (4)

  • Attitude regarding implementation of smoke free policy (perceptions and attitude of cab drivers)

    30 months

  • Oral cancer detection by oral screening

    30 months

  • Quit rates (self reported quit rates)

    30 months

  • Reactions towards no tobacco messages (Reactions of the commuters and their own perceptions)

    30 months

Study Arms (2)

Tobacco users: behavioural counseling

EXPERIMENTAL

The cab drivers using tobacco will be invited to participate in the tobacco cessation programme at the TCC and will receive three monthly follow-up for one year. Thus intervention will be in the form of behavioural therapy and pharmacotherapy (if required)

Behavioral: Tobacco usersDrug: Pharmacotherapy

Non Users

NO INTERVENTION

The cab drivers who are not using tobacco in any form will not receive any type of intervention

Interventions

Tobacco usersBEHAVIORAL

Various tobacco cessation interventions in the form of one to one counseling, focus group discussions, role plays, games etc. will be used in the tobacco users.

Tobacco users: behavioural counseling
PharmacotherapyDRUG

Pharmacotherapy will also be prescribed as per the need assessment consisting of: Nicotine Chewing Gums: Dose: 2 mg/4 mg, 10-15 pieces per day with maximum dose of 24 pieces/day depending on cravings.Total Duration: 12 weeks Duration of treatment: Higher dose for 4-6 weeks, with weaning till 2-3 months Nicotine Transdermal patches: Dose: 7 mg/10 mg/14 mg/21 mg -for 24-hours use. Total Duration: 12 weeks Duration of treatment: Higher strength patch for 2 weeks and depending on cravings will be gradually decreased till 4 weeks

Also known as: Nicotine replacement therapy
Tobacco users: behavioural counseling

Eligibility Criteria

Sexmale
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Cab drivers ferrying customers near Tata Memorial Hospital on a regular basis

You may not qualify if:

  • Any Cab drivers outside the category as mentioned in the proposal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gauravi A. Mishra

Mumbai, Maharashtra, 400012, India

Location

MeSH Terms

Conditions

Patient Compliance

Interventions

Drug TherapyNicotine Replacement Therapy

Condition Hierarchy (Ancestors)

Patient Acceptance of Health CareTreatment Adherence and ComplianceHealth BehaviorBehavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Gauravi A Mishra, Assoc Prof

    Tata Memorial Hospital, Mumbai

    PRINCIPAL INVESTIGATOR

  • Sharmila A Pimple, Professor

    Tata Memorial Hospital, Mumbai

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SCREENING
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor & Physician

Study Record Dates

First Submitted

December 11, 2014

First Posted

February 3, 2015

Study Start

December 1, 2014

Primary Completion

April 1, 2018

Study Completion

April 1, 2018

Last Updated

April 30, 2018

Record last verified: 2018-04

Locations

IN(1)