PMCAN for Smokers at Smoking Hotspots

Study Overview
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Brief Summary
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Background: Many smokers cannot quit due to nicotine withdrawal symptoms, which peak at the first week of abstinence. Proactive recruitment of smokers is needed as most smokers do not seek smoking cessation (SC) services. A smoking hotspot (SH) is defined as a public outdoor place where smokers stop/linger and smoke. We aim to include a reasonably representative or unbiased sample of SH at different locations from all 3 regions of Hong Kong. We will randomly select 6 eligible SH (2 in each regions) from the 15 hotspots in our previous community trial. Methods: Two trained SC ambassadors (student helpers) and one supervisor (experienced research assistant) will be deployed for each session of intervention at a SH. Potential subjects will be approached using the a-foot-into-the-door method in which SC ambassador will ask if smoker would like to reduce/quit smoking and receive SC intervention or advices. Smokers will be assessed for eligibility and informed written consent will be sought. Subjects will complete a brief self-administered questionnaire (baseline) using tablet. To reduce later hang-ups of telephone interventions or surveys, SC ambassador will save contact number of the trial into subjects' mobile phones. Discussion: The findings will provide much needed and original evidence to support a main RCT on these new, proactive, simple and low-cost interventions for improving current SC services and policy for smokers who do not actively seek help from SC services in Hong Kong and elsewhere.

Official Title
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Proactive Minimal Cessation Advice Plus Nicotine Replacement Therapy (PMCAN) for Smoking Cessation in Smokers at Smoking Hotspots: a Pilot Randomized Controlled Trial

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine Replacement Therapy (NRT)
* Behavioral: Minimal Cessation Advice (MCA)
* Other: Health warning leaflet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult smokers aged 18+ who smoke cigarettes daily. Exhaled carbon monoxide (CO) level of 4ppm or above. Hong Kong residents able to read and communicate in Chinese (Cantonese or Putonghua) Exclusion Criteria: Smokers who have contraindication for NRT use: severe angina, arrhythmia, myocardia infraction, pregnancy (or intended to become pregnant <6 months) or breastfeeding. Smokers who have psychiatric/psychological diseases or regular psychotropic medications Smokers who are using SC medication, NRT, other SC services or projects.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nicotine Replacement Therapy<br>This experimental group receives health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days. | Drug: Nicotine Replacement Therapy (NRT)<br>* 1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.<br>* Other names: NRT;Other: Health warning leaflet<br>* An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.<br>|
| Experimental: Minimal Cessation Advice & Nicotine Replacement Therapy<br>This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet, 1-week free nicotine replacement therapy (gum/patch), a card containing instruction and potential side effects and follow-up intervention if they have the above side effects at 3-, 7- and 10-days. | Drug: Nicotine Replacement Therapy (NRT)<br>* 1-week free NRT (gum/patch) plus a card containing instruction and potential side effects.<br>* Other names: NRT;Behavioral: Minimal Cessation Advice (MCA)<br>* Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.<br>* Other names: MCA;Other: Health warning leaflet<br>* An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.<br>|
| Experimental: Minimal Cessation Advice<br>This experimental group receives brief smoking cessation advice using AWARD model with a health warning leaflet. | Behavioral: Minimal Cessation Advice (MCA)<br>* Brief smoking cessation advice using AWARD model. AWARD: (1) Ask smoking habit; (2) Warn about smoking risk; (3) Advice to quit as soon as possible; (4) Refer to smoking cessation service; and (5) Do-it-again: if relapse/fail.<br>* Other names: MCA;Other: Health warning leaflet<br>* An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.<br>|
| Active Comparator: Control<br>This control group receives a health warning leaflet. | Other: Health warning leaflet<br>* An A4 double-side color leaflet containing shocking pictures of diseases associated with smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exhaled CO validated abstinence |  | 3 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported past 7-day point prevalence abstinence |  | 3 month | 
| Nicotine Replacement Therapy use |  | 3 month | 
| Smoking cessation service use |  | 3 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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minimal cessation advice, proactive, nicotine replacement therapy, smoking hotspots