Sponsor study identifier
interventional
1,448
1 country
1
Study Start
July 3, 2023
Actual (reported)Primary Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Objective: To test the efficacy of a self-determination theory-based intervention plus instant messaging to help smokers with cancer quit smoking. Hypothesis to be tested: Subjects who are allowed to choose their quit schedule and receive regular instant messaging about smoking cessation will show a significantly higher biochemically validated quit rate than those who receive only brief advice to quit immediately. Design and Subjects: An RCT will be conducted to 1448 smokers with cancer attending the outpatient clinics of five major acute care hospitals in Hong Kong for medical follow-up. Instruments: A structured questionnaire will be used to assess subjects' smoking history and demographic and clinical characteristics. EQ-5D-5L will be used to measure subjects' quality of life. Interventions: The intervention group will receive brief advice and will be invited to choose their own quit schedules (immediate or progressive) in the outpatient clinics. They will receive instant messaging about smoking cessation during the first 6-month follow-up period. The control group will receive brief advice to quit smoking immediately in the outpatient clinics, and will receive a placebo intervention during the first 6-month follow-up period. Subjects in both groups will receive leaflets on smoking cessation.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 30, 2022
Actual (reported)December 8, 2022
Actual (reported)July 3, 2023
Actual (reported)May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
biochemically validated smoking abstinence (saliva cotinine level and Carbon monoxide level in expired air) at 6 months
biochemically validated smoking abstinence at 6 months follow-up between intervention and control group. The biochemically validated smoking abstinence will be confirmed by a saliva cotinine level of \<30 ng/ml with a saliva cotinine test paper and a carbon monoxide level in expired air of \<4 parts per million (ppm) with a carbon monoxide monitor.
6 months follow-up
biochemically validated smoking abstinence (saliva cotinine level and carbon monoxide level in expired air) at 12 months
12 months follow-up
self-reported 7-day point prevalence of smoking abstinence at 6 months measured by structured questionnaires
6 months follow-up
self-reported 7-day point prevalence of smoking abstinence at 12 months measured by structured questionnaires
12 months follow-up
self-reported reduction of ≥50% cigarette consumption at 6 months measured by structured questionnaires
6 months follow-up
self-reported reduction of ≥50% cigarette consumption at 12 months measured by structured questionnaires
12 months follow-up
Each subject will receive a specially designed leaflet for smokers with cancer. subjects will receive brief interventions using the AWARD model and they will be allowed to select their own quit schedules (quit immediately, or quit progressively) with the ultimate goal of complete cessation. Subjects who opt to quit progressively will receive a smoking reduction leaflet. Over the next 6 months, the research nurse will help them to adhere to their schedules by sending WhatsApp/WeChat messages. subjects will receive four independent 1-minute videos (one video will be sent in weeks 1, 5, 9, and 13) via WhatsApp/WeChat.
Subjects will receive a brief intervention using the AWARD model. However, all subjects will be advised to quit immediately. Control group subjects will receive the same leaflet for smokers with cancer as intervention group subjects. Subjects will receive a placebo intervention that follows the same WhatsApp/WeChat schedule as the intervention group, but the messages will contain only general health advice, such as to perform more physical activity and eat more fruit and vegetables. The control group will not receive any videos.
subjects will receive brief interventions using the AWARD model and they will be allowed to select their own quit schedules (quit immediately, or quit progressively) with the ultimate goal of complete cessation. Follow-up booster intervention with WhatsApp/WeChat messages to help them to adhere to their schedules and independent 1-minute videos will be delivered.
Subjects will receive a brief intervention using the AWARD model and all of them will advise to quit immediately. Only general health advice via WhatsApp/WeChat will be delivered.
The Chinese University of Hong Kong
Hong Kong, Hong Kong
Ho Cheung William Li, PhD
Chinese University of Hong Kong
First Submitted
November 30, 2022
First Posted
December 8, 2022
Study Start
July 3, 2023
Actual (reported)Primary Completion
May 2026
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This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
May 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
December 5, 2025
Record last verified: 2025-12
The relevant anonymized patient level data, full dataset, technical appendix, and statistical code are available on reasonable request. The approval from the Principal Investigator for the purpose of data use is required.
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Source: ClinicalTrials.gov.
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