Clinical trial NCT06261385: Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
Official title: Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Smoking Cessation
Lead sponsor: The University of Hong Kong
Sponsor class: OTHER
Collaborators: name: Health and Medical Research Fund
First posted: 2024-02-15
Enrollment: 510
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This study aims to develop a typology-based intervention delivered by smoking cessation (SC) counselors to prevent smoking relapse in ex-smokers who recently quit. The two main research questions include (1) Can a typology-based smoking relapse prevention intervention be feasible and accepted by the smokers and SC counselors who deliver the new intervention? (2) What is the preliminary evidence on the efficacy of the typology-based smoking relapse prevention to increase tobacco abstinence in ex-smokers who have recently quit? If the intervention shows at least a small effect size (i.e. risk ratio\>1.3), or the intervention is feasible while modifications can potentially increase the efficacy, a future definitive RCT is warranted.

Detailed description: 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 8 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.

Eligibility criteria: Inclusion Criteria (for Ex-smoker) :

* Have ever habitually used conventional cigarettes in the past year
* Not using cigarettes for past 7 days
* Aged 18 years or above
* No barriers in speaking and listening Chinese

Exclusion Criteria (for Ex-smoker) :

* Have unstable physical or psychological conditions as advised by doctors or counsellors
* Users of illicit drugs (e.g., heroin, marijuana, ketamine, etc.)
* Have become pregnant in the past two months

Inclusion Criteria (for SC counsellors) :

* SC counsellors from local SC clinics under Tung Wah Group of Hospitals, Pok Oi Hospital, Hospital Authority (HA), and Youth Quitline of the University of Hong Kong.

Primary outcomes:
measure: self-reported abstinence in the past 30 days at 2-month follow-up
timeFrame: 2 months
measure: iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence
timeFrame: 2 months
measure: the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group.
timeFrame: 2 months
Secondary outcomes:
measure: Time required for the counselling
timeFrame: 2 months
measure: Compliance rate of the SC counsellors in following the intervention protocol
timeFrame: 2 months
measure: Proportion of screened clients who participate in the RCT
timeFrame: 2 months
measure: Dropout rate of the participants who consent to the RCT
timeFrame: 2 months
measure: Satisfaction on the SC counsellors
timeFrame: 2 months
measure: Satisfaction on the e-messages
timeFrame: 2 months
measure: Frequency of reading the e-messages
timeFrame: 2 months
measure: Perceived effectiveness on the intervention
timeFrame: 2 months
measure: Satisfaction on the enrolment procedures
timeFrame: 2 months
measure: Intention to recommend the intervention to other smokers
timeFrame: 2 months
measure: Satisfaction about the intervention from SC counsellor
timeFrame: 2 months
measure: Perceived appropriateness of the intervention length from SC counsellor
timeFrame: 2 months
measure: Satisfaction on the enrolment procedures from SC counsellor
timeFrame: 2 months
measure: Perceived effectiveness of the screening tool from SC counsellor
timeFrame: 2 months
measure: Perceived clients' acceptance of the intervention from SC counsellor
timeFrame: 2 months
measure: Intention to apply this intervention in other clients from SC counsellor
timeFrame: 2 months
Other outcomes:
Locations:
city: Hong Kong
country: Hong Kong
facility: LKS Faculty of Medicine
Study officials:
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