A Randomized Controlled Trial to Test the Effect of a Smartphone Quit Smoking Intervention on Young Adult Smokers

Study Overview
=================
Brief Summary
-----------------
The primary aim of this study will be to determine the effectiveness of a smartphone delivered app for young adult smokers on quitting smoking.

Detailed Description
-----------------
The principle study purpose of the randomized controlled trial is to determine the effectiveness of a smartphone delivered app for young adult smokers on smoking cessation at six months using a randomized controlled trial. Secondary aims of this study include examining: 1) proximal outcome measures of cessation behaviour; 2) satisfaction, extent of app use and use of NRT and other cessation services; 3) mediators of cessation outcomes between conditions; and 4) the incremental cost-effectiveness.

Official Title
-----------------
Effect of a Smartphone Intervention on Quitting Smoking in a Young Adult Population of Smokers: A Randomized Controlled Trial

Conditions
-----------------
Cigarette Smoking

Intervention / Treatment
-----------------
* Behavioral: Crush the Crave Application
* Behavioral: On the Road to Quitting - Self Help


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 19 to 29 years Currently smoking cigarettes daily or occasionally Residing in Canada Considering quitting smoking in the next 30 days Have an Android or iPhone OS smartphone Able to provide informed consent English comprehension Not referred by a study participant Exclusion Criteria: - opposite of the above

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 29 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Crush the Crave Application<br>Crush the Crave (CTC) intervention group will receive a quit smoking smartphone intervention via the internet that is based on scientific findings related to tobacco use among young adults. It is a multi-component intervention informed by evidence on quitting smoking. The app was developed with the input of key experts in the field of smoking cessation, was assessed against Fiore's practice guidelines for treating tobacco use and dependence, and was tested with eight focus groups of male and female young adult smokers (n=57) on functionality, look and feel and usability, as well as being piloted by over 300 smokers. | Behavioral: Crush the Crave Application<br>* Crush the Crave (CTC) allows users to customize a quit plan by choosing a quit date and then deciding whether to quit now or cut down the number of cigarettes they smoke every week up to the quit date. CTC reminds users of money saved and health improvements. Based on contingency reinforcement, rewards are provided, which smokers can then choose to share with their social network via Facebook. Supportive text messages tailored to their specific quit plan and where they are in the quitting experience are provided. CTC allows tracking of daily smoking habits and cravings as well as craving triggers or psychosocial determinants by recording when, where and why smoking occurred. Online distractions to help smokers deal with cravings are provided.<br>* Other names: Facebook;|
| Active Comparator: On the Road to Quitting - Self Help<br>The control group will receive an evidence-based self-help guide known as On the Road to Quitting(45) that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide. | Behavioral: On the Road to Quitting - Self Help<br>* The control group will receive an evidence-based self-help guide known as On the Road to Quitting that has been developed by Health Canada for young adult smokers. Participants will be able to both view the self-help guide via the internet and will receive a printed version of the guide.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30 day point prevalence of abstinence | 30 day point prevalence of abstinence at 6 months,operationalized as not having smoked any cigarettes, even a puff, or used other tobacco in the last 30 days. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day abstinence | 7 day point prevalence of abstinence at 6 months,operationalized as not having smoked any cigarettes, even a puff, or used other tobacco in the last 30 days | 6 months | 
| Number of quit attempts | How many times did you stop using tobacco for 24 hours or longer over the past six months? | 6 months | 
| Consumption of cigarettes | Reduction in the consumption of cigarettes since baseline and behavioural intentions to quit smoking using questions from the Minimal Dataset and nicotine withdrawal using the Fagerstrom test for nicotine dependence. | Baseline and at 6 months | 
| Satisfaction and App Utilization | Satisfaction with program, app utilization metrics, and use of smoking cessation services (NRT, health professional consults,medications and quitline counseling) | 6 months | 
| Psychosocial measures | Beliefs, attitudes and social norms using the Smoking Attitudes Scale, stress using the 14-item Perceived Stress Scale, self-efficacy using Etter's 12 items, and perceived social support using the modified 7-item subjective support subscale of the Duke Social Support Index. | Baseline and at 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Population Health, Smoking cessation, Young adults, Cancer prevention, Tobacco control strategies, Behaviour modification, Social Media, Smartphone technology