Applying mHealth to Tobacco-related Health Disparities

Study Overview
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Brief Summary
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The purpose of this study is to better understand what happens when someone attempts to quit smoking.

Detailed Description
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Investigators will provide participants with nicotine patches, smoking cessation treatment that will include brief counseling sessions (10-15 minutes each), and text messages sent to their provided study phone throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts. Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. Mobile Health (mHealth) is a general term for the use of mobile phones and other wireless technology in medical care. The key outcome and hypothesized mechanisms (i.e., lapse and stress) will be measured objectively and automatically using AutoSense. AutoSense is a type of human sensing technology that allows investigators to detect smoking behavior and stress objectively through a chest strap and wrist bands worn by participants. Ecological momentary assessment (EMA) will assess acute precipitants such as negative affect, craving, self-efficacy, motivation, alcohol consumption, etc. Questionnaires will assess other predictors and mechanisms.

Official Title
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Applying mHealth to Tobacco-related Health Disparities: Enhancing Aspects of Resiliency to Aid Cessation Efforts (Time2Quit)

Conditions
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Smoking Cessation

Intervention / Treatment
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* Drug: Nicotine Patch
* Behavioral: Counseling
* Behavioral: Smartphone
* Other: AutoSense


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Smoked a minimum of 3 cigarettes per day over the past year Expired carbon monoxide reading ≥ 6 Motivated to quit within the next 30 days Valid home address Functioning telephone number Can speak, read, and write in English At least marginal health literacy Exclusion Criteria: Contraindication for the nicotine patch (e.g., heart attack, angina, skin allergies) unless a doctor's note is provided Endorse current psychosis Have a pacemaker or implanted device Physically unable to wear equipment and provide a good reading of physiological measures Current use of tobacco cessation medications Current use of of smoking products other than cigarettes and e-cigarettes Involvement in a smoking program or currently trying to quit Pregnancy or lactation Another household member being enrolled in the study No prior experience with a smart phone The study staff or principal investigator (PI) have serious concerns about the participant's ability to engage in and/or complete the study protocol.

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Smoking Cessation Therapy<br>Participants will receive 6 weeks of the nicotine patch therapy and brief counseling sessions. Participants will also receive mindfulness strategies for 10 days during both the pre- and post-quit periods via smartphone to aid in their cessation attempt. AutoSense will be worn to detect stress and lapse throughout the 10 day period. | Drug: Nicotine Patch<br>* Nicotine patches and thorough education of the indications for the patch will be provided to all participants.<br>Behavioral: Counseling<br>* Brief counseling sessions, 10-15 minutes each.<br>Behavioral: Smartphone<br>* Ecological momentary assessment (EMA) assesses participants' moment-to-moment subjective experiences via self-report assessments on a smart phone. Participants will receive mindfulness strategies for 10 days pre- and post-quit via smart phone to aid in their cessation attempt. Text messages will be sent to provided study phones throughout the day. These messages will be short (1-3 minutes long) and will ask participants to do things like focus on the present moment, pay attention to their breathing, and be aware of their current thoughts.<br>Other: AutoSense<br>* Participants will be asked to wear equipment throughout the day that will measure their physiology and smoking behavior. AutoSense unobtrusively and objectively collects physiological and behavioral data (i.e., negative affect (NA), self-regulatory capacity (SRC), and smoking) via wearable chest and wrist sensors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of Smoking Lapse | Lapse will be measured objectively and automatically from the equipment worn by participants (AutoSense). | Up to 36 months | 
| Rate of Stress | Stress will be measured objectively and automatically from the equipment worn by participants (AutoSense). | Up to 36 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cigarettes, quit smoking, nicotine, mindfulness, mHealth, mobile health