SmokingNCT02701686
A Comparison of the Effectiveness of Two Approaches in Achieving Smoking Abstinence
A study testing quit immediately (QI) and cut down to quit (CDTQ) in people with Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- quit immediately (QI) and cut down to quit (CDTQ)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteHong Kong
- Study dates
- Jun 2014to Nov 2016
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- aged 18 years or above,
- smoke at least two cigarettes per day,
Who cannot join
- those with unstable medical conditions as advised by the doctor in charge,
- poor cognitive state or mental illness,
- participation in other smoking cessation programmes or services.
Trial locations and contacts
1 site in 1 country.
Hong Kong1 site
Sai Ying Pun Jockey Club General Out-patient Clinic in Hong Kong
Hong Kong
About this study
Official title: A Comparison of the Effectiveness of Two Approaches (Quit Immediately: QI and Cut Down to Quit: CDTQ) in Achieving Smoking Abstinence Among Patients Having Follow-up in a GOPC: A Pilot Randomized Controlled Trial
The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed.
Read the detailed description
Introduction:
A brief intervention with a small to moderate effect size can potentially benefit a large number of smokers and increase smoking cessation within the community if it is carried out routinely in clinical practices by all or most healthcare professionals or people with minimal training. It is also the most cost-effective smoking cessation programme, because no extra or minimal funding is needed to provide the venue, manpower, and other expenses (but incentives or payments to healthcare professionals and follow-up support would be needed). There is no evidence that longer interventions are more effective than shorter interventions. Brief cessation interventions have been shown to be effective with strong evidence from the investigators' randomised controlled trials and in systematic reviews.
The negotiating self-determination to reduce cigarette consumption is guided by social cognitive and self-determination theories. According to social cognitive theory, self-efficacy is an important personal determinant of human behaviour and has been defined as the belief in one's capability to engage in behaviour to solve difficult tasks. This belief influences decisions on whether a certain form of behaviour will be adopted and maintained. Because self-efficacy is built on a successful experience of overcoming challenging tasks, smokers who have more successful experiences in reducing cigarette consumption tend to have higher levels of self-efficacy. Some evidence has shown that a reduction in smoking may lead to greater self-efficacy to resist smoking, which could increase subsequent quitting. According to self-determination theory, autonomy is another influential determinant of behaviours which is emphasized by freedom of choice. Studies have shown that patients having an opportunity to decide on their own treatment may feel more eager to comply with instructions. The subjects in this study will be allowed to select their own schedules of smoking reduction after the negotiation with the counsellor, such as the percentage of smoking reduction over an acceptable period of time. It is anticipated that the subjects will show more willingness to adhere to their own schedule as a result of an increase in autonomy. Moreover, some evidence has shown that autonomy is positively associated with competence; that is, people have greater autonomy demonstrate higher competence in achieving behavioural change. Consequently, autonomy will facilitate their gradual reduction or cessation of smoking. Most importantly, as a result of reducing the cigarette consumption and lowering down the nicotine dependence, it would be much easier for such smokers to further reduce or quit.
Methods:
Chinese patients attending the general out-patient clinics in Hong Kong for routine follow-up visits who fulfil the following inclusion criteria will be invited to participate in the study.
All smoking patients will be approached by a nurse counselors.
Analysis:
Data analysis will be performed using the Statistical Package for Social Science. In particular, we will use inferential statistics (independent-samples t-test and χ2 test) to examine the homogeneity between the QI and CDTQ groups. We will conduct logistic regression analyses to calculate the odds ratio (OR) and 95% confidence interval (CI) for smoking outcomes, i.e. self-reported and biochemical validated quit rates, self-reported smoking reduction rates and number of quit attempts. We will apply mixed between-within subjects analysis of variance (ANOVA) to determine whether CDTQ is more effective than QI in enhancing self-efficacy (perceived importance, difficulty and confidence) for quitting smoking. We shall adopt the principle of intention to treat. Subjects who are lost to follow-up, refuse to participate in biochemical validations, or withdraw from the study are considered unable to quit or reduce smoking. Depending on the amount and distribution of missing data, other methods, e.g. sensitivity analysis and multiple imputation technique will be used if necessary.
- Conditions
- Smoking
- Being tested
- quit immediately (QI), cut down to quit (CDTQ)
- Keywords
- smoking cessation
- Medical subject headings
- Smoking, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
quit immediately (QI)Behavioural
advise to quit immediately using the AWARD model
cut down to quit (CDTQ)Behavioural
advise to reduce cigarette consumption and quit eventally using the AWARD model
| Study group | Role | What they receive |
|---|---|---|
| quit immediately (QI) | Experimental | Subjects in the QI group will receive a smoking cessation booklet plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit now, as quitting can greatly reduce risks, (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention during each telephone follow-up. The whole intervention will be limited to less than 1 min or slightly longer if necessary. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the counsellor will congratulate to the subjects who successfully quit smoking, while deliver the same brief intervention as a booster for those who continue to smoke. Receives: Behavioral: quit immediately (QI) |
| cut down to quit (CDTQ) | Experimental | Subjects in the CDTQ group will also receive the smoking cessation booklet plus a brief intervention using the AWARD model. Instead of asking them to quit immediately, they will be advised gradually cutting down on their cigarette consumption. Also, the subjects will be provided with an education card that contains reduction strategies and a suggested plan to reduce smoking. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the nurse counsellor will repeat the warning message that one out of two smokers will be killed by smoking, and remind the subjects of their next reduction target. The counsellor will congratulate subjects who quit or reduce smoking on their success. When subjects fail to quit or reduce their cigarette consumption, the counsellor will reinforce the health hazards of continued smoking and the benefits of quitting, and encourage them to try again immediately or in the near future. Receives: Behavioral: cut down to quit (CDTQ) |
What is being measured
The primary outcome is the main question the study is designed to answer.
self-reported 7-day point prevalence of abstinence
Measured: 6 months
self-reported 7-day point prevalence of abstinence
Measured: 12 months
self-reported reduction of ≥ 50% in cigarette consumption
Measured: 6 months
self-reported reduction of ≥ 50% in cigarette consumption
Measured: 12 months
Secondary outcomes (6)
biochemically validated abstinence (exhaled CO test & saliva cotinine test)
Measured: 6 months
biochemically validated abstinence (exhaled CO test & saliva cotinine test)
Measured: 12 months
self-efficacy in quitting
Measured: 6 months
self-efficacy in quitting
Measured: 12 months
number of quit attempts made
Measured: 6 months
number of quit attempts made
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2016 (estimated)
- Study startJun 2014
- Primary completionMay 2016
- Study completionNov 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. LI William Ho Cheung, The University of Hong Kong
- Investigators
- William, Ho Cheung Li, PhD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02701686
- Sponsor's protocol ID
- GOPC
- Status last verified
- Apr 2017
- First submitted
- 26 Feb 2016
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of the Effectiveness of Two Approaches (Quit Immediately: QI and Cut Down to Quit: CDTQ) in Achieving Smoking Abstinence Among Patients Having Follow-up in a GOPC: A Pilot Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02701686
- Acronym / sponsor ID
- GOPC
- Conditions
- Smoking
- Keywords
- smoking cessation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Study start
- Jun 2014 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- Nov 2016 (actual)
- First posted
- 8 Mar 2016 (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.
The purpose of this study is to test the effectiveness of negotiating self determination to reduce cigarette consumption. A single-blinded multi-centre randomized controlled is employed.
Detailed description
Introduction:
A brief intervention with a small to moderate effect size can potentially benefit a large number of smokers and increase smoking cessation within the community if it is carried out routinely in clinical practices by all or most healthcare professionals or people with minimal training. It is also the most cost-effective smoking cessation programme, because no extra or minimal funding is needed to provide the venue, manpower, and other expenses (but incentives or payments to healthcare professionals and follow-up support would be needed). There is no evidence that longer interventions are more effective than shorter interventions. Brief cessation interventions have been shown to be effective with strong evidence from the investigators' randomised controlled trials and in systematic reviews.
The negotiating self-determination to reduce cigarette consumption is guided by social cognitive and self-determination theories. According to social cognitive theory, self-efficacy is an important personal determinant of human behaviour and has been defined as the belief in one's capability to engage in behaviour to solve difficult tasks. This belief influences decisions on whether a certain form of behaviour will be adopted and maintained. Because self-efficacy is built on a successful experience of overcoming challenging tasks, smokers who have more successful experiences in reducing cigarette consumption tend to have higher levels of self-efficacy. Some evidence has shown that a reduction in smoking may lead to greater self-efficacy to resist smoking, which could increase subsequent quitting. According to self-determination theory, autonomy is another influential determinant of behaviours which is emphasized by freedom of choice. Studies have shown that patients having an opportunity to decide on their own treatment may feel more eager to comply with instructions. The subjects in this study will be allowed to select their own schedules of smoking reduction after the negotiation with the counsellor, such as the percentage of smoking reduction over an acceptable period of time. It is anticipated that the subjects will show more willingness to adhere to their own schedule as a result of an increase in autonomy. Moreover, some evidence has shown that autonomy is positively associated with competence; that is, people have greater autonomy demonstrate higher competence in achieving behavioural change. Consequently, autonomy will facilitate their gradual reduction or cessation of smoking. Most importantly, as a result of reducing the cigarette consumption and lowering down the nicotine dependence, it would be much easier for such smokers to further reduce or quit.
Methods:
Chinese patients attending the general out-patient clinics in Hong Kong for routine follow-up visits who fulfil the following inclusion criteria will be invited to participate in the study.
All smoking patients will be approached by a nurse counselors.
Analysis:
Data analysis will be performed using the Statistical Package for Social Science. In particular, we will use inferential statistics (independent-samples t-test and χ2 test) to examine the homogeneity between the QI and CDTQ groups. We will conduct logistic regression analyses to calculate the odds ratio (OR) and 95% confidence interval (CI) for smoking outcomes, i.e. self-reported and biochemical validated quit rates, self-reported smoking reduction rates and number of quit attempts. We will apply mixed between-within subjects analysis of variance (ANOVA) to determine whether CDTQ is more effective than QI in enhancing self-efficacy (perceived importance, difficulty and confidence) for quitting smoking. We shall adopt the principle of intention to treat. Subjects who are lost to follow-up, refuse to participate in biochemical validations, or withdraw from the study are considered unable to quit or reduce smoking. Depending on the amount and distribution of missing data, other methods, e.g. sensitivity analysis and multiple imputation technique will be used if necessary.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| quit immediately (QI) | Experimental | Behavioral: quit immediately (QI)Subjects in the QI group will receive a smoking cessation booklet plus a brief intervention using the AWARD model: (a) Ask about smoking history, (b) Warn about the high risk, (c) Advise to quit now, as quitting can greatly reduce risks, (d) Refer smokers to a smoking cessation clinic, and (e) Do it again: repeat the intervention during each telephone follow-up. The whole intervention will be limited to less than 1 min or slightly longer if necessary. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the counsellor will congratulate to the subjects who successfully quit smoking, while deliver the same brief intervention as a booster for those who continue to smoke. |
| cut down to quit (CDTQ) | Experimental | Behavioral: cut down to quit (CDTQ)Subjects in the CDTQ group will also receive the smoking cessation booklet plus a brief intervention using the AWARD model. Instead of asking them to quit immediately, they will be advised gradually cutting down on their cigarette consumption. Also, the subjects will be provided with an education card that contains reduction strategies and a suggested plan to reduce smoking. For the subsequent telephone follow-ups at 1, 3, 6 and 12 months, the nurse counsellor will repeat the warning message that one out of two smokers will be killed by smoking, and remind the subjects of their next reduction target. The counsellor will congratulate subjects who quit or reduce smoking on their success. When subjects fail to quit or reduce their cigarette consumption, the counsellor will reinforce the health hazards of continued smoking and the benefits of quitting, and encourage them to try again immediately or in the near future. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- aged 18 years or above,
- smoke at least two cigarettes per day,
Key exclusion criteria (3 listed)
- those with unstable medical conditions as advised by the doctor in charge,
- poor cognitive state or mental illness,
- participation in other smoking cessation programmes or services.
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 |
|---|---|---|
| quit immediately (QI)advise to quit immediately using the AWARD model | Behavioural | quit immediately (QI) |
| cut down to quit (CDTQ)advise to reduce cigarette consumption and quit eventally using the AWARD model | Behavioural | cut down to quit (CDTQ) |
Primary outcome
self-reported 7-day point prevalence of abstinence
Time frame: 6 months
self-reported 7-day point prevalence of abstinence
Time frame: 12 months
self-reported reduction of ≥ 50% in cigarette consumption
Time frame: 6 months
self-reported reduction of ≥ 50% in cigarette consumption
Time frame: 12 months
6 secondary outcomes
biochemically validated abstinence (exhaled CO test & saliva cotinine test)
Time frame: 6 months
biochemically validated abstinence (exhaled CO test & saliva cotinine test)
Time frame: 12 months
self-efficacy in quitting
Time frame: 6 months
self-efficacy in quitting
Time frame: 12 months
number of quit attempts made
Time frame: 6 months
number of quit attempts made
Time frame: 12 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 28 Apr 2017.
- 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.
William, Ho Cheung Li, PhD principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing quit immediately (QI) and cut down to quit (CDTQ) in people with Smoking, run by The University of Hong Kong at 1 site in Hong Kong.
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 2 inclusion and 3 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 28 Apr 2017. 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 Hong Kong. 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?
self-reported 7-day point prevalence of abstinence (time frame: 6 months). The study lists 4 primary outcomes in all. 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 28 Apr 2017.