Quit Smoking Text Message Study

Study Overview
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Brief Summary
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This project will address research gaps and advance the science of smoking cessation by conducting a randomized controlled trial of an evidence-based, population-level quit smoking text messaging program with or without a smartband.

Detailed Description
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Aim 1 of this study is to test within-treatment effects for smoking cessation. The primary outcome will be biochemically (cotinine)-confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks). Secondary outcomes will be percent days smoke-free, time to relapse, and rated treatment satisfaction. Aim 2 of this study is to explore sex/gender differences in treatment effects for smoking cessation. Given established sex/gender differences in smoking behavior and cessation,randomization will be stratified by sex/gender and we will measure effects of sex/gender on outcomes. Effect sizes will be estimated for smoking outcomes by sex.

Official Title
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Evaluating Digital Health Interventions To Promote Smoking Cessation

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: SmokefreeTXT
* Device: Smartband


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: daily smokers for at least 6 months report an interest in quitting smoking. Exclusion Criteria: reporting being currently enrolled in another quit smoking program

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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No

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: SmokefreeTXT<br>Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT. | Other: SmokefreeTXT<br>* National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user.<br>|
| Experimental: SmokefreeTXT + smartband<br>Daily smokers for at least 6 months who report an interest in quitting will be randomized to receive the National Cancer Institute's SmokefreeTXT + smartband. | Other: SmokefreeTXT<br>* National Cancer Institute's SmokefreeTXT is a text message quit smoking program available nationally. Users sign up and choose a target quit date that is within 2 weeks of their signup date. Users receive 3-5 text messages per day for up to 2 weeks pre-quit and 6 weeks post-quit. The quit date can be reset as often as needed by the user.<br>Device: Smartband<br>* A smartband that will track smoking in real-time and ask the individual to confirm/deny smoking. Participants will be asked to wear the smartband during their waking hours and to charge it overnight.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with cotinine confirmed 7-day point-prevalence abstinence (PPA) at end of treatment (8 weeks) | 7-day PPA at end of treatment with be confirmed via cotinine testing in saliva | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cigarettes smoked per day | Change in average number cigarettes smoked per day by self report | baseline, 4 weeks and 8 weeks | 
| Percent days smoke-free | Percentage of smoke-free days by self report | up to 8 weeks | 
| Average number of days to relapse | Relapse is defined as 7 consecutive days of smoking after quitting and will be measured using self-report or smartband detection. This will be assessed after their quit date. | 2 weeks post quit date | 
| Treatment satisfaction assessed using the User Burden Scale | User burden scale: User burden will be assessed using items on a 5 point Likert scale with scores from 0 (not at all/never) to 4 (extremely/all of the time). Means will be reported for 6 subscales (difficulty of use, physical, time and social, mental and emotional, privacy, financial) and an overall scale range 0 to 80, with higher scores indicating more user burden. | up to 8 weeks | 
| Treatment satisfaction assessed using the System Usability Scale | System usability scale: Uses 10 items ranked from 1 (strongly disagree) to 5 (strongly agree) with a total score 0-100 with higher score indicating better system usability. | up to 8 weeks | 
| Treatment satisfaction assessed using the Mobile Application Rating Scale User version | This 20-item scale uses 5-point multiple choice ratings and has 6 subscales. Scores are reported as: 1) mean app quality, which is the mean score for the 4 subscales engagement, functionality, aesthetics, information quality; 2) mean of the app subjective quality subscale, and 3) mean of the perceived impact subscale. Higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. Mean scores range 1-5, with higher scores indicate higher app quality, higher app subjective quality, and higher perceived impact. | up to 8 weeks | 
| Treatment satisfaction assessed using the Acceptability of Intervention Measure | Acceptability of Intervention Measure includes three scales for Acceptability of Intervention Measure (AIM), Intervention Appropriateness Measure (IAM), and Feasibility of Intervention Measure (FIM). Each measure includes 4 items rated on a 5-point Likert scale from completely disagree to completely agree and average subscale responses are reported (out of 5) with higher scores indicating greater acceptability, appropriateness, or feasibility. | up to 8 weeks |