Smoking Clinical Trial
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.
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.
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