This pilot study includes three phases. The first phase will be a Q-sorting process on
the Q-statements which have been developed in the pilot study. Phase 2 will be the
development of a typology assessment tool, intervention protocol, and training. Phase 3
will be a pilot randomized controlled trial to examine the feasibility, acceptability and
preliminary efficacy of the typology-based intervention. Ethics approval will be obtained
from the Institutional Review Board of the University of Hong Kong/Hong Kong Authority
Hong Kong West Cluster.
This study protocol complies with the Declaration of Helsinki and the International
Conference on Harmonisation Guideline for Good Clinical Practice (ICH-GCP).
Phase 1 Q-method study (5 months) In phase 1, ex-smokers will be recruited online and in
local community-based SC clinics. Mass mails including study details will be sent to all
HKU staff and students. Recruitment ads will also be posted on online platforms such as
Google, Facebook, and Instagram. Participants will be directed to an online Qualtrics to
complete a brief screening questionnaire and provide their contact information for the
sign-up process. SC clinics or services under Tung Wah Group of Hospitals, Pok Oi
Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong,
which offer behaviour and/or pharmacological interventions. The investigators have
successful experience collaborating with these service providers in recruiting smokers
for several projects. For example, the investigators recruited 1,008 ex-smokers from
these service providers in an HMRF-funded project in 2018-2019 (Project No. 15163001). In
these clinics, potential participants shall be identified by the SC counsellors and
referred to our research assistants to proceed with enrolment. In phase 3, the
investigators will only recruit ex-smokers from SC clinics, because biochemical
verification of both abstinence and habitual tobacco use before quitting in ex-smokers
recruited from the community does not exist.
The Q-statements have been developed in our aforementioned pilot study. The Q-sorting
process will be conducted on an online platform "easyHTMLQ" (Appendix 2), which is
designed for completion of the Q-sorting. In this self-explanatory website, participants
can easily drag the statements into the Q-sort grid according to their agreement level,
and provide detailed reasons for their choices. Also, the research assistant will
communicate with participants online and monitor the Q-sorting process. After the Q-sort
process, the results will be documented and exported for further data analysis.
Phase 2 Intervention development (6 months) In phase 2, the investigators shall invite SC
counsellors from the above SC clinics to participate in either face-to-face or online
project meetings to provide feedback on the intervention protocols.
This phase aims to develop a typology assessment tool and design a typology-based
intervention protocol, using the findings in Phase 1, the 3 aforementioned principles of
typology-based intervention, and current smoking cessation guidelines. The screening
protocol will include distinguishing statements found in Phase 1 that can characterise
ex-smokers. The intervention protocol will include specific counselling principles and
content for each ex-smoker class and a series of typology-based e-messages to be
delivered to the corresponding class of ex-smokers via WhatsApp after counselling. The
counselling shall take 5 to 10 minutes and can be fitted in current intervention
protocols (5A/5R/Motivational Interview), that can address quit motivation, smoking cues
and nicotine dependence.
After intervention development, the project team will invite SC counsellors for a project
meeting to provide feedback on the intervention protocols. Afterwards, the project team
shall revise the protocols and deliver a briefing for the SC counsellors who will deliver
the intervention in Phase 3.
Phase 3 Pilot randomized control trial (7 months) The pilot 2-arm, parallel,
open-labelled RCT (allocation ratio 1:1) aims to examine the feasibility, acceptability
and preliminary efficacy of the typology-based intervention. SC counsellors who attend
the briefing in Phase 2 will screen and recruit their SC clients to receive the
typology-based intervention for smoking cessation. The SC counsellors from local clinical
settings that can recruit a relatively large number of participants within the 12-week
recruitment will be included, to ensure timely recruitment of sufficient participants.
During the last remote consultation with a client (mostly at 4 weeks), the SC counsellors
will assess their eligibility. If they are eligible, the SC counsellors will seek their
written consent and randomize them to either the intervention group or the control group.
In the intervention group, in addition to routine counselling (15-30 minutes), they will
classify their identity with our screening tool (developed in Phase 2) and then apply the
counselling protocol for the participants (5-10 minutes). After the counselling session,
the personalized e-messages will be sent to the participants by our research staff for 4
weeks.
In the control group, routine smoking cessation counselling, including generic advice on
preventing smoking relapse, will be retained, and no e-messages will be sent. The
investigators only deploy usual practice but not equal contact/attention treatment for
the control group because the investigators aim for a superiority trial to assess the
preliminary efficacy of the new intervention.
