Smoking Cessation
Conditions
Keywords
Q-methdololgy, Relapse Prevention, Randomized Controlled Trial
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 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.
Interventions
BEHAVIORALtypology-based intervention
The typology-based intervention includes: 1. typology-based counselling, 2. personalized E-message based on the counselling content discussed 3. a booklet introducing the typology of quit identity. All interventions and materials are delivered by smoking counselling.
BEHAVIORALRoutine Treatment
The routine smoking cessation intervention includes: 1. Routine counselling generic advice on preventing smoking relapse 2. Brief e-messages that consist of general quit advice for 4 weeks. Counsellors implement both routine practices.
Sponsors
Health and Medical Research Fund
The University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
open-labelled RCT
Intervention model description
2-arm: Intervention group and Control group
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
(for Ex-smoker) : * Being a daily smoker before enrolling into the smoking cessation service * Not using cigarettes for past 7 days * Received at least 4 weeks of smoking cessation service before enrolling into the study * Aged 18 years or above * No barriers in speaking and listening Cantonese and Mandarin and reading Chinese
Exclusion criteria
(for Ex-smoker) : * Have unstable physical or psychological conditions as advised by doctors or counsellors * 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 Integrated Center on Smoking Cessation and United Christian Nethersole Community Health Service
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| self-reported abstinence in the past 30 days at 2-month follow-up | 2 months | — |
| iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence | 2 months | Participants who report tobacco abstinence will be invited for a biochemical validation to test if his/her saliva cotinine is less than 30ng/ml measured by the iScreen OFD Cotinine Saliva Test Kit. |
| the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group. | 2 months | We will have 4 feasibility questions and 4 appropriateness questions for counsellor to answer from 1 (Completely disagree) to 5 (Completely agree). Also, we will have 4 acceptability questions for ex-smokers to answer. We would like to observe if there is a difference between the intervention group and the control group |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Dropout rate of the participants who consent to the RCT | End of all follow-up (approximately 6 month) | The dropout rate is calculated by Number of participants dropout from study / Total number of enrolled participant |
| Satisfaction on the SC counsellors | 2 months | Satisfaction on the SC counsellors is measured by a 5 point Likert scale reported by the enrolled participants. |
| Satisfaction on the e-messages | 2 months | Satisfaction on the e-messages is measured by a 10 point Likert scale reported by the enrolled participants. |
| Frequency of reading the e-messages | 2 months | The Frequency of reading the e-messages is measured by 5 point Likert scale, which includes the option (5) I read all of them, (4) I read most of them, (3) I read half of them, (2) I read some of them, and (1) I read none of them. |
| Perceived effectiveness on the intervention | 2 months | The perceived effectiveness on the intervention is measured by a 10 point likert scale. Participant will rate the usefulness of the messages in helping them to maintain smoking abstinence (10: Very useful \| 0: Useless). |
| Satisfaction on the enrolment procedures | 2 months | Satisfaction on the enrolment procedures is measured by a 10 point Likert scale reported by the participants (0: The enrollment procedure is slow and complicated \| 10: the enrollment procedure is fast and simple). |
| Time required for the counselling | End of all follow-up (approximately 6 month) | The average time required for the typological counselling in minutes |
| Satisfaction about the intervention from SC counsellor | End of all follow-up (approximately 6 month) | Satisfaction about the intervention from SC counsellor is measured by a 5 point Likert scale. SC counsellor will rate the effectiveness of the typological counselling in helping their client to quit smoking, from 1: very ineffective to 5: very effective. |
| Perceived appropriateness of the intervention length from SC counsellor | End of all follow-up (approximately 6 month) | The perceived appropriateness of the intervention length from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the length of the typological counselling is suitable for their client, from 1 strongly disagree to 5 strongly agree. |
| Satisfaction on the enrolment and counselling procedures from SC counsellors | End of all follow-up (approximately 6 month) | The satisfaction on the enrolment procedures from SC counsellors is measured by a 5 point Likert scale. Counsellors will be asked if they agreed that enrolment and counselling procedures is simple and could be easily done in the SC clinics, from 1: strongly disagree to 5: strongly agree. |
| Perceived effectiveness of the screening tool from SC counsellor | End of all follow-up (approximately 6 month) | The perceived effectiveness of the screening tool from SC counsellor is measured by a 5 point Likert scale. SC counsellor will be asked if they agreed that the typological intervention can help them screen out smokers who are prone to relapse, from 1: strongly disagree to 5: strongly agree. |
| Perceived clients' acceptance of the intervention from SC counsellor | 2 months | The Perceived clients' acceptance of the intervention from SC counsellor is measured by a 5 point Likert scale. Participants are asked if they agreed that counselling content provided the SC counselling gain their trust and acceptance, from 1: strongly disagree to 5: strongly agree. |
| Intention to apply this intervention in other clients from SC counsellors | End of all follow-up (approximately 6 month) | Intention to apply this intervention in other clients from SC counsellors is measured by a 5 point Likert scale. SC counsellors are asked if they want to apply the typological intervention to other clients in future, 1: I will not apply it to my client in the future, 5: I want to apply it my client in the future. |
| Intention to recommend the intervention to other smokers | 2 months | Intention to recommend the intervention to other smokers is measured by a 10 point Likert scale, 10: strongly recommended to other smokers \| 0: not recommended to other smoker |
| Compliance rate of the SC counsellors in following the intervention protocol | End of all follow-up (approximately 6 month) | There were 26 questions in the counselling protocol. SC counsellors have to record the number of questions asked during the typological counselling. The rate is calculated by number of questions asked/26. |
| Proportion of screened clients who participate in the RCT | End of all follow-up (approximately 6 month) | The proportion is calculated by Number of enrolled participants / Total number of participant screened |
Countries
Hong Kong
Outcome results
None listed