Clinical trial NCT02354638: Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai
Official title: Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai, India
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Compliance
Keywords: Perceptions
Education and evaluate post intervention KAP
Lead sponsor: Tata Memorial Hospital
Sponsor class: OTHER_GOV
First posted: 2015-02-03
Enrollment: 400
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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.

Detailed description: AIM and OBJECTIVES:

1. To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco and smoke free public places among cab drivers ferrying customers near Tata Memorial Hospital
2. To study the impact of smoke free public places with specific reference to smoke free cabs (on various factors such as number of customers, customer practices, health status, self practices, compliance etc.)
3. To understand their attitude towards smoke free cabs.
4. To educate them regarding hazards of tobacco and the need for smoke free cabs.
5. To invite the cab drivers using tobacco to avail the Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
6. To evaluate the compliance for availing the services
7. To study the post-intervention KAP regarding tobacco and smoke free public places
8. To determine the rate of oral pre-cancers and tobacco cessation after one year follow-up.

Methodology:

Design: Single arm interventional study

Step 1: Around 400 cab drivers in Mumbai will be enrolled after explaining the programme and obtaining informed consent. They will be interviewed with the help of a well structured questionnaire to collect information about their Knowledge, Attitudes and Practices (KAP) regarding tobacco, their attitudes and experiences regarding smoke free public places with specific reference to smoke free cabs.

Step 2: The cab drivers will be given detailed health education regarding hazards of tobacco and the need for smoke free cabs. They will be invited to participate in oral cancer screening at the Preventive Oncology (PO) screening clinic.

Step 3: The cab drivers will be again interviewed with the help of a well structured questionnaire to collect information of their post-intervention KAP regarding tobacco and smoke free public places.

Step 4: 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. Various tobacco cessation interventions in the form of one to one counseling, focus group discussions, role plays, games etc. will be used. In addition they will be engaged in conveying messages about tobacco control and refraining from tobacco habit, to the customers while commuting. This will also reinforce their own commitment towards tobacco cessation.

Variables to be estimated:

1. the change in the baseline KAP
2. the perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.
3. the results of oral cancer screening in the form of oral pre-cancers and cancers detected
4. the success of tobacco cessation programme in the form of self reported quit rates at the end of one year
5. reactions of the commuters and their own perceptions towards the no tobacco messages conveyed to the customers while traveling

Data Analysis:

Data entry will be done in the Department of Preventive Oncology, Tata Memorial Hospital using SPSS version 18. Checks for consistency, data safety and analysis will be carried out at regular intervals. Both descriptive and inferential statistics will be generated for describing variables under the study objectives.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Primary outcomes:
measure: Knowledge, Attitude & practice (change in the baseline KAP)
timeFrame: 30 months
Secondary outcomes:
measure: Attitude regarding implementation of smoke free policy (perceptions and attitude of cab drivers)
timeFrame: 30 months
measure: Oral cancer detection by oral screening
timeFrame: 30 months
measure: Quit rates (self reported quit rates)
timeFrame: 30 months
measure: Reactions towards no tobacco messages (Reactions of the commuters and their own perceptions)
timeFrame: 30 months
Other outcomes:
Locations:
city: Mumbai
country: India
facility: Gauravi A. Mishra
state: Maharashtra
Study officials:
affiliation: Tata Memorial Hospital, Mumbai
name: Gauravi A Mishra, Assoc Prof
role: PRINCIPAL_INVESTIGATOR
affiliation: Tata Memorial Hospital, Mumbai
name: Sharmila A Pimple, Professor
role: PRINCIPAL_INVESTIGATOR
References: