Efficacy of a Self-determination Theory-based Smoking Cessation Intervention Plus Instant Messaging Via Mobile Application for Smokers With Cancer: A Pragmatic Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 1,448
- 试验地点
- 1
- 主要终点
- biochemically validated smoking abstinence (saliva cotinine level and Carbon monoxide level in expired air) at 6 months
研究概览
简要总结
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.
详细描述
Setting:
The setting is outpatient clinics of five major acute care hospitals in different clusters in Hong Kong.
Intervention group
In outpatient clinics Subjects will first receive a brief intervention using the Ask, Warn, Advise, Refer, and Do-it-again (AWARD) model. Previous clinical trials of smoking cessation have provided evidence of the effectiveness of brief interventions using the AWARD model. The brief intervention will comprise the following steps: (1) ask about smoking history; (2) warn about the high morbidity and mortality risks associated with smoking; (3) advise to quit: subjects will be allowed to select their own quit schedules after discussing their situation with the research nurse [quit immediately (QI), or quit progressively (QP) with the ultimate goal of complete cessation]. The content Scripts for the QI and QP interventions will emphasize the health benefits of quitting; (4) refer smokers to a smoking cessation clinic or a smoking cessation hotline: 1833183; and (5) do it again: repeat the intervention and encourage smokers who fail to quit or relapse to try again during each telephone follow-up. The whole intervention will last approximately 5-8 minutes. This brief intervention will be cost-effective and more feasible for routine use in clinical practice by healthcare professionals after minimal training.
Subjects who opt to quit progressively will receive a smoking reduction leaflet, which contains reduction strategies and a suggested plan to reduce smoking. Subjects will also be given the option to consider a tailored quit schedule for themselves after the discussions with the research nurse. The research nurse will motivate subjects to reduce cigarette consumption and then quit at their own pace, but the whole process should not exceed 6 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •smoked weekly in the last 6 months,
- •diagnosed with any cancer for at least 6 months and at all cancer stages (I, II, III, or IV),
- •aged 18 years or above and can communicate in Cantonese, and
- •own a smartphone and able to use instant messaging (e.g. WhatsApp or WeChat)
排除标准
- •individuals with unstable medical conditions, poor cognitive state, or mental illness as advised by the doctor in charge and noted on their medical records, and
- •those participating in other smoking cessation programmes.
结局指标
主要结局
biochemically validated smoking abstinence (saliva cotinine level and Carbon monoxide level in expired air) at 6 months
时间窗: 6 months follow-up
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.
次要结局
- biochemically validated smoking abstinence (saliva cotinine level and carbon monoxide level in expired air) at 12 months(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)
- self-reported 7-day point prevalence of smoking abstinence at 6 months measured by structured questionnaires(6 months follow-up)
- quality of life at 6 months measured by EQ-5D five-level questionnaire (EQ-5D-5L)(6 months follow-up)
- self-reported 7-day point prevalence of smoking abstinence at 12 months measured by structured questionnaires(12 months follow-up)
- quality of life at 12 months measured by EQ-5D five-level questionnaire (EQ-5D-5L)(12 months follow-up)
研究者
Li Ho Cheung William
Professor
Chinese University of Hong Kong