protocolSection identificationModule nctId: NCT06261385, orgStudyIdInfo id: typology, briefTitle: Development of Typology-based Smoking Relapse Prevention: A Q-methodology and a Pilot Randomized Controlled Trial, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-23, primaryCompletionDateStruct date: 2024-10-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: The University of Hong Kong, class: OTHER, collaborators name: Health and Medical Research Fund, descriptionModule briefSummary: 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., conditionsModule conditions: Smoking Cessation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors at the telephone follow-up are blinded to the group allocation., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 510, type: ESTIMATED, armsInterventionsModule interventions name: typology-based intervention, outcomesModule primaryOutcomes measure: self-reported abstinence in the past 30 days at 2-month follow-up, primaryOutcomes measure: iScreen OFD Cotinine Saliva Test Kit (<30ng/ml) biochemical validated tobacco abstinence, primaryOutcomes measure: the difference of the feasibility and acceptability score of the typology-based intervention between the intervention and control group., secondaryOutcomes measure: Time required for the counselling, secondaryOutcomes measure: Compliance rate of the SC counsellors in following the intervention protocol, secondaryOutcomes measure: Proportion of screened clients who participate in the RCT, secondaryOutcomes measure: Dropout rate of the participants who consent to the RCT, secondaryOutcomes measure: Satisfaction on the SC counsellors, secondaryOutcomes measure: Satisfaction on the e-messages, secondaryOutcomes measure: Frequency of reading the e-messages, secondaryOutcomes measure: Perceived effectiveness on the intervention, secondaryOutcomes measure: Satisfaction on the enrolment procedures, secondaryOutcomes measure: Intention to recommend the intervention to other smokers, secondaryOutcomes measure: Satisfaction about the intervention from SC counsellor, secondaryOutcomes measure: Perceived appropriateness of the intervention length from SC counsellor, secondaryOutcomes measure: Satisfaction on the enrolment procedures from SC counsellor, secondaryOutcomes measure: Perceived effectiveness of the screening tool from SC counsellor, secondaryOutcomes measure: Perceived clients' acceptance of the intervention from SC counsellor, secondaryOutcomes measure: Intention to apply this intervention in other clients from SC counsellor, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LKS Faculty of Medicine, status: RECRUITING, city: Hong Kong, zip: 00, country: Hong Kong, contacts name: Derek YT Cheung, PhD, role: CONTACT, phone: +852 3917 6652, email: derekcheung@hku.hk, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False