Community-Centered eHealth Smoking Cessation Intervention(CCeSCI)

Study Overview
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Brief Summary
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Recent findings regarding why Chinese male smokers are reluctant to quit have offered insight for a possible new solution. Consistent with the Cognitive Dissonance Theory, smoking rationalization beliefs are a set of beliefs by smokers to rationalize their smoking behavior and avoid quitting. These beliefs have been well studied by global researchers, and a smoking rationalization beliefs scale was recently developed and validated for Chinese male smokers. The six dimensions of these beliefs are: smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs, and quitting is harmful beliefs. Studies on smoking rationalization in China have primarily been observational. Investigators propose to develop a Community-Centered eHealth Smoking Cessation Intervention (CCeSCI). The trinity of CCeSCI are the triangular unity of smoking rationalization beliefs framework, the non-physician community workers, and the eHealth technologies. The latter two were previously proven effective in interventional studies (including three conducted by the PI) but not yet widely used in smoking cessation. With the adoption of smoking rationalization beliefs framework aiming to address the cognitive causes of phycological addition to smoking and supported by the community-based behavioral interventions and the use of eHealth, CCeSCI is designed to overcome previous challenges with the principles of people-centeredness, convenience, and personalization.

Detailed Description
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Investigators will firstly evaluate the feasibility of CCeSCI. Once CCeSCI is ready to deploy, investigators will recruit 60 smokers (male, 25-64 years old) in two communities in Qingpu to conduct a pilot non-blinded randomized controlled trial. They will be randomized in a 1:1 ratio into either the intervention group to receive CCeSCI or the control group to receive the traditional smoking is harmful education video. Investigators will also use qualitative research methods (one on one interviews) to conduct process evaluations at 4th, 8th, and 12th weeks according to the RE-AIM (Reach, Effectiveness, Adoption, Implementation, Maintenance) framework. At the end of the 12th week after the participants joined the RCT, saliva samples will be collected by community workers and quitting outcomes will be biochemically verified by a third party lab.

Official Title
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Community-Centered eHealth Smoking Cessation Intervention Based on the Smoking Rationalization Beliefs Framework for Chinese Male Smokers

Conditions
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Smoking Cessation, Lifestyle, Healthy

Intervention / Treatment
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* Other: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI)
* Other: Traditional smoking is harmful education


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male, current cigarette smokers who are willing to quit Citizens who currently reside in Qingpu District, Shanghai, China Age 25-64 Smoking index greater than or equal to 100 (smoking index = average number of cigarettes smoked per day × years of smoking) Able to understand mandarin Chinese Willing to provide informed consent to participate in the study Exclusion Criteria: Ever or currently on pharmacologic treatments, including various forms of NRT formulations such as gum, transdermal patch, nasal spray, oral inhaler, lozenge, Bupropion, Varenicline and newly emerged precision medicine Currently participating in other individual-based cessation program(s), such as psychological counseling, behavioral therapy etc. Currently under treatment of life-threatening medical conditions or critically ill Unable to make commitment of a consecutive 4-hour video viewing Plan to move out of the community in the next 3 month

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 64 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI) group<br>The intervention group will receive Community-Centered eHealth Smoking Cessation Intervention(CCeSCI). | Other: Community-Centered eHealth Smoking Cessation Intervention (CCeSCI)<br>* We will equip CCeSCI with both core eHealth features and provider-side intervention. Patients assigned to the intervention group will receive a series of online interactive and personalization technologies, including an algorithm-based video curriculum with auto-texting, backstage monitoring system etc. Besides, the patients will also have the face-to-face meetings with community health workers. Provider-side intervention includes training for community workers, WeChat group discussion, and performance-based incentives. The training aims to provide essential skills for community workers so that they can provide face-to-face meetings with smokers during the first 3 months of quitting to prevent or revert relapse in a timely and proactive manner.<br>|
| Active Comparator: Traditional smoking is harmful education group<br>The control group to receive the traditional smoking is harmful education. | Other: Traditional smoking is harmful education<br>* In the control group, the participants will receive traditional smoking is harmful education video, which is recorded by the clinical physicians.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biochemically verified continuous smoking abstinence at 3 month | Investigators will use cotinine to measure the smoking abstinence. Cotinine is a good biomarker for nicotine with a longer half-life (16-18h), and lab test for saliva is highly sensitive, convenient, and cost-effective. measured by cotinine saliva tests (<10ng•mL-1) | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fagerstrom Test For Nicotine Dependence (FTND) Score | Investigators will use the Fagerström Test for Nicotine Dependence as a standard instrument for assessing the intensity of physical addiction to nicotine. In scoring the Fagerstrom Test for Nicotine Dependence, the three yes/no items are scored 0 (no) and 1 (yes). The three multiple-choice items are scored from 0 to 3. The items are summed to yield a total score of 0-10. A higher score means more dependence on nicotine. | Change from baseline to 3-month follow up | 
| Patient Health Questionnaire-9 | Investigators will use PHQ-9 as a 9-question instrument to screen for depression. The scale ranges from 0 to 27. Total scores of 5, 10, 15, and 20 represent cutpoints for mild, moderate, moderately severe, and severe depression, respectively. Higher score indicates severe depression | Change from baseline to 3-month follow up | 
| Self-reported 7-day point smoking status | self-reported 7-day point prevalence of abstinence (not even a puff of smoke, for the last 7 days) at 3 months | 3-month follow up | 
| Self-reported continuous abstinence at 3 month | not even a puff of smoke, for the last 3 months | 3-month follow up | 
| Self-reported average number of cigarettes | Investigators will count the number of cigarettes at 3 month | Change from baseline to 3-month follow up | 
| Smoking Rationalization Scale | Investigators will use Smoking Rationalization Scale to measure smokers' thoughts about smoking. The scale comprised 26 items (e.g., Smoking is good for inspiration and active thinking.) and was divided into 6 dimensions including smoking functional beliefs, risk generalization beliefs, social acceptability beliefs, safe smoking beliefs, self-exempting beliefs and quitting is harmful beliefs. Participants responded on a 5-point Likert scale (1 = completely disagree, 5 = completely agree). Higher scores indicated a higher level of smoking rationalization beliefs. | Change from baseline to 3-month follow up | 
| Questionnaire about community health workers' Knowledge, Attitude and Practices (KAP) | The knowledge, attitude, and practices (KAPs) survey provides a design to evaluate existing programs and to identify effective strategies for behavior change in society. The first section was related to knowledge, and this section had some questions where 1 point was assigned to the correct answer and 0 points were assigned to the wrong answer. A higher score demonstrated good knowledge. The second section was on attitude and had some questions on a 5-point Likert scale as strongly disagree = 1, disagree = 2, uncertain = 3, agree = 4, and strongly agree = 5. A higher score demonstrated a good attitude. The last part of the questionnaire was composed of questions related to the practice, and each question was scored as yes (1-point), no (0-point), and sometimes (0-point). A higher score indicated good practice. | 3-month follow up | 
| Weight in kilograms | Investigators will measure the participants' heights | Change from baseline to 3-month follow up | 
| Blood Pressure | Investigators will measure the participants' both systolic and diastolic blood pressure | Change from baseline to 3-month follow up | 
| Waist Circumference | Investigators will measure the waist circumference of the participants | Change from baseline to 3-month follow up | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Cessation, Disease control and prevention, Health management, Effectiveness evaluation