ComplianceNCT02354638
Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai
A study testing Tobacco users and Pharmacotherapy in people with Compliance, run by Tata Memorial Hospital at 1 site in India.
Trial 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. Read more about this study
- Who is it for?
- Any age, men onlyHealthy volunteers can take part
- Conditions the study is for
- Compliance
- What is being tested?
- Tobacco users and Pharmacotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteIndia
- Study dates
- Dec 2014to Apr 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 400 Cab drivers ferrying customers near Tata Memorial Hospital on a regular basis
Who cannot join
- Any Cab drivers outside the category as mentioned in the proposal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai, India
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.
Read more
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.
Read the detailed description
AIM and OBJECTIVES:
- To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco and smoke free public places among cab drivers ferrying customers near Tata Memorial Hospital
- 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.)
- To understand their attitude towards smoke free cabs.
- To educate them regarding hazards of tobacco and the need for smoke free cabs.
- To invite the cab drivers using tobacco to avail the Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
- To evaluate the compliance for availing the services
- To study the post-intervention KAP regarding tobacco and smoke free public places
- 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:
- the change in the baseline KAP
- the perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.
- the results of oral cancer screening in the form of oral pre-cancers and cancers detected
- the success of tobacco cessation programme in the form of self reported quit rates at the end of one year
- 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.
- Conditions
- Compliance
- Being tested
- Tobacco users, Pharmacotherapy
- Keywords
- Perceptions, Education and evaluate post intervention KAP
- Medical subject headings
- Patient Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tobacco usersBehavioural
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.
PharmacotherapyDrug
Also called Nicotine replacement therapy
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
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Behavioral: Tobacco users; Drug: Pharmacotherapy |
| Non Users | No intervention | The cab drivers who are not using tobacco in any form will not receive any type of intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Knowledge, Attitude & practice (change in the baseline KAP)
- The
Measured: 30 months
Secondary outcomes (4)
Attitude regarding implementation of smoke free policy (perceptions and attitude of cab drivers)
- The perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.
Measured: 30 months
Oral cancer detection by oral screening
c)The results of oral cancer screening in the form of oral pre-cancers and cancers detected
Measured: 30 months
Quit rates (self reported quit rates)
- The success of tobacco cessation programme in the form of self reported quit rates at the end of one year
Measured: 30 months
Reactions towards no tobacco messages (Reactions of the commuters and their own perceptions)
- Reactions of the commuters and their own perceptions towards the no tobacco messages conveyed to the customers while traveling
Measured: 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2015 (estimated)
- Study startDec 2014
- Primary completionApr 2018
- Study completionApr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ComplianceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tata Memorial Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Gauravi Ashish Mishra, Tata Memorial Hospital
- Investigators
- Gauravi A Mishra, Assoc Prof, Principal investigator, Tata Memorial Hospital, MumbaiSharmila A Pimple, Professor, Principal investigator, Tata Memorial Hospital, Mumbai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02354638
- Sponsor's protocol ID
- TMHPOCAB2015
- Status last verified
- Apr 2018
- First submitted
- 11 Dec 2014
- Last updated
- 30 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Smoke Free Public Places (Smoke Free Cabs) on Cab Drivers in Mumbai, India
- ClinicalTrials.gov ID
- NCT02354638
- Acronym / sponsor ID
- TMHPOCAB2015
- Conditions
- Compliance
- Keywords
- Perceptions, Education and evaluate post intervention KAP
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Tata Memorial HospitalOther government
- Study start
- Dec 2014
- Primary completion
- Apr 2018 (actual)
- Study completion
- Apr 2018 (actual)
- First posted
- 3 Feb 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- To study the Knowledge, Attitudes and Practices (KAP) regarding tobacco and smoke free public places among cab drivers ferrying customers near Tata Memorial Hospital
- 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.)
- To understand their attitude towards smoke free cabs.
- To educate them regarding hazards of tobacco and the need for smoke free cabs.
- To invite the cab drivers using tobacco to avail the Preventive Oncology screening facilities and Tobacco cessation clinic at the Tata Memorial Hospital
- To evaluate the compliance for availing the services
- To study the post-intervention KAP regarding tobacco and smoke free public places
- 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:
- the change in the baseline KAP
- the perceptions and attitude of cab drivers regarding implementation of smoke free cab policy.
- the results of oral cancer screening in the form of oral pre-cancers and cancers detected
- the success of tobacco cessation programme in the form of self reported quit rates at the end of one year
- 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.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tobacco users: behavioural counseling | Experimental | Behavioral: Tobacco users, Drug: PharmacotherapyThe 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) |
| Non Users | No intervention | –The cab drivers who are not using tobacco in any form will not receive any type of intervention |
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 400 Cab drivers ferrying customers near Tata Memorial Hospital on a regular basis
Key exclusion criteria (1 listed)
- Any Cab drivers outside the category as mentioned in the proposal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tobacco usersVarious 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. | Behavioural | Tobacco users: behavioural counseling |
| PharmacotherapyAlso: Nicotine replacement therapyPharmacotherapy 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 | Drug | Tobacco users: behavioural counseling |
Primary outcome
Knowledge, Attitude & practice (change in the baseline KAP)
Time frame: 30 months
a) The
4 secondary outcomes
Attitude regarding implementation of smoke free policy (perceptions and attitude of cab drivers)
Time frame: 30 months
Oral cancer detection by oral screening
Time frame: 30 months
Quit rates (self reported quit rates)
Time frame: 30 months
Reactions towards no tobacco messages (Reactions of the commuters and their own perceptions)
Time frame: 30 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gauravi A Mishra, Assoc Prof principal investigator
Tata Memorial Hospital, Mumbai
Sharmila A Pimple, Professor principal investigator
Tata Memorial Hospital, Mumbai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tobacco users and Pharmacotherapy in people with Compliance, run by Tata Memorial Hospital at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Knowledge, Attitude & practice (change in the baseline KAP) (time frame: 30 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2018.