Smoking Cessation Clinical Trial
Official title:
Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial
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.
Status | Recruiting |
Enrollment | 510 |
Est. completion date | January 31, 2025 |
Est. primary completion date | October 31, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Hong Kong | LKS Faculty of Medicine | Hong Kong |
Lead Sponsor | Collaborator |
---|---|
The University of Hong Kong | Health and Medical Research Fund |
Hong Kong,
Berger J, Rand L. Shifting Signals to Help Health: Using Identity Signaling to Reduce Risky Health Behaviors. Journal of Consumer Research. 2008;35(3):509-18.
Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 64: Pattern of Smoking. Hong Kong: Census & Statistics Department 2018.
Census & Statistics Department (Hong Kong SAR government). Thematic Household Survey, Report No. 70: Pattern of Smoking. Hong Kong: Census & Statistics Department 2020.
Cheung YT, Chan CH, Lai CK, Chan WF, Wang MP, Li HC, Chan SS, Lam TH. Using WhatsApp and Facebook Online Social Groups for Smoking Relapse Prevention for Recent Quitters: A Pilot Pragmatic Cluster Randomized Controlled Trial. J Med Internet Res. 2015 Oct 22;17(10):e238. doi: 10.2196/jmir.4829. — View Citation
Food and Health Bureau, Department of Health. Towards 2025: Strategy and action plan to prevent and control non-communicable diseases in Hong Kong. Hong Kong: Department of Health; 2018.
GBD 2016 Risk Factors Collaborators. Global, regional, and national comparative risk assessment of 84 behavioural, environmental and occupational, and metabolic risks or clusters of risks, 1990-2016: a systematic analysis for the Global Burden of Disease — View Citation
Hartmann-Boyce J, Livingstone-Banks J, Ordonez-Mena JM, Fanshawe TR, Lindson N, Freeman SC, Sutton AJ, Theodoulou A, Aveyard P. Behavioural interventions for smoking cessation: an overview and network meta-analysis. Cochrane Database Syst Rev. 2021 Jan 4;1:CD013229. doi: 10.1002/14651858.CD013229.pub2. — View Citation
Jackson SE, McGowan JA, Ubhi HK, Proudfoot H, Shahab L, Brown J, West R. Modelling continuous abstinence rates over time from clinical trials of pharmacological interventions for smoking cessation. Addiction. 2019 May;114(5):787-797. doi: 10.1111/add.14549. Epub 2019 Jan 29. — View Citation
Kufeld C. A Q-Methodology study investigating the identity self-descriptions of a group of ex-smokers. England: University of Luton; 2004.
Lam TH. Absolute risk of tobacco deaths: one in two smokers will be killed by smoking: comment on "Smoking and all-cause mortality in older people". Arch Intern Med. 2012 Jun 11;172(11):845-6. doi: 10.1001/archinternmed.2012.1927. No abstract available. — View Citation
Livingstone-Banks J, Norris E, Hartmann-Boyce J, West R, Jarvis M, Hajek P. Relapse prevention interventions for smoking cessation. Cochrane Database Syst Rev. 2019 Feb 13;2(2):CD003999. doi: 10.1002/14651858.CD003999.pub5. — View Citation
Luk TT, Cheung YTD, Chan HC, Fok PW, Ho KS, Sze CD, Lam TH, Wang MP. Mobile Chat Messaging for Preventing Smoking Relapse Amid the COVID-19 Pandemic: A Pilot Randomized Controlled Trial. Nicotine Tob Res. 2023 Jan 5;25(2):291-297. doi: 10.1093/ntr/ntac045. — View Citation
McGhee SM, Ho LM, Lapsley HM, Chau J, Cheung WL, Ho SY, Pow M, Lam TH, Hedley AJ. Cost of tobacco-related diseases, including passive smoking, in Hong Kong. Tob Control. 2006 Apr;15(2):125-30. doi: 10.1136/tc.2005.013292. — View Citation
Meijer E, Gebhardt WA, Dijkstra A, Willemsen MC, Van Laar C. Quitting smoking: The importance of non-smoker identity in predicting smoking behaviour and responses to a smoking ban. Psychol Health. 2015;30(12):1387-409. doi: 10.1080/08870446.2015.1049603. Epub 2015 Jun 3. — View Citation
Montes KS, Pearson MR. I am what I am: A meta-analysis of the association between substance user identities and substance use-related outcomes. Psychol Addict Behav. 2021 May;35(3):231-246. doi: 10.1037/adb0000721. Epub 2021 Apr 8. — View Citation
Oyserman D, Smith GC, Elmore K. Identity-based motivation: Implications for health and health disparities. J Soc Iss. 2014;70(2):206-25.
Oyserman D. Identity-based motivation: Implications for action-readiness, procedural-readiness, and consumer behavior. J Consum Psychol. 2009;19(3):250-60.
Smith AL, Chapman S, Dunlop SM. What do we know about unassisted smoking cessation in Australia? A systematic review, 2005-2012. Tob Control. 2015 Jan;24(1):18-27. doi: 10.1136/tobaccocontrol-2013-051019. Epub 2013 Sep 11. — View Citation
Susan ER, Isadore N. Q Methodology and Its Position in the Mixed-Methods Continuum. Operant Subjectivity. 2011;34(3):172-91.
Tajfel H, Turner JC. The Social Identity Theory of Intergroup Behavior. In: Sidanius JTJJ, editor. Political psychology: Key readings. Key readings in social psychology. New York, NY, US: Psychology Press; 2004. p. 276-93.
Tombor I, Shahab L, Herbec A, Neale J, Michie S, West R. Smoker identity and its potential role in young adults' smoking behavior: A meta-ethnography. Health Psychol. 2015 Oct;34(10):992-1003. doi: 10.1037/hea0000191. Epub 2015 Jan 26. — View Citation
Watts S, Stenner P. Doing the fieldwork: participants, materials and procedure. 2012 2022/03/11. In: Doing Q Methodological Research: Theory, Method and Interpretation [Internet]. London: SAGE Publications Ltd; [69-90]. Available from: https://methods.sagepub.com/book/doing-q-methodological-research.
Whittaker R, McRobbie H, Bullen C, Rodgers A, Gu Y. Mobile phone-based interventions for smoking cessation. Cochrane Database Syst Rev. 2016 Apr 10;4(4):CD006611. doi: 10.1002/14651858.CD006611.pub4. — View Citation
World Health Organization. A guide for tobacco users to quit. Geneva: World Health Organization; 2014.
Zabala A, Pascual U. Bootstrapping Q Methodology to Improve the Understanding of Human Perspectives. PLoS One. 2016 Feb 4;11(2):e0148087. doi: 10.1371/journal.pone.0148087. eCollection 2016. — View Citation
* Note: There are 25 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | self-reported abstinence in the past 30 days at 2-month follow-up | 2 months | ||
Primary | iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence | 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. | 2 months | |
Primary | the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group. | We will have 4 feasibility questions for participants to answer from 1 (Completely disagree) to 5 (Completely agree). Also, we will have 13 acceptability questions modified from Treatment Acceptability/Adherence Scale (TAAS), graded from 1 (Disagree strongly) to 7 (Agree strongly). We would like to observe if there is difference between the score from intervention group and control group | 2 months | |
Secondary | Time required for the counselling | 2 months | ||
Secondary | Compliance rate of the SC counsellors in following the intervention protocol | 2 months | ||
Secondary | Proportion of screened clients who participate in the RCT | 2 months | ||
Secondary | Dropout rate of the participants who consent to the RCT | 2 months | ||
Secondary | Satisfaction on the SC counsellors | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Satisfaction on the e-messages | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Frequency of reading the e-messages | 2 months | ||
Secondary | Perceived effectiveness on the intervention | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Satisfaction on the enrolment procedures | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Intention to recommend the intervention to other smokers | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Satisfaction about the intervention from SC counsellor | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Perceived appropriateness of the intervention length from SC counsellor | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Satisfaction on the enrolment procedures from SC counsellor | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Perceived effectiveness of the screening tool from SC counsellor | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Perceived clients' acceptance of the intervention from SC counsellor | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months | |
Secondary | Intention to apply this intervention in other clients from SC counsellor | We will have 8 questions, graded from 1 (very disagree) to 5 (very agree) | 2 months |
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