A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App Smiling Instead of Smoking (SiS)

Study Overview
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Brief Summary
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This is the third study in a series of 3 studies to develop a smartphone app to support nondaily smokers in quitting smoking, as funded by the American Cancer Society grant #RSG CPPB - 130323 (project dates: 07/01/2017 - 6/30/2021). Study 1 (2017P001106) demonstrated feasibility and acceptability when smokers were onboarded in person. Study 2 (2018P002699) demonstrated feasibility and acceptability when smokers were onboarded remotely, nationwide. The present study is Study 3. It is a 3-group proof-of-concept RCT, in which we seek to test if our app (i.e., Version 3 of our developed smartphone app, called 'Smiling instead of Smoking' (SiS)) is superior to treatment as usual (i.e., TAU) and superior to a control app (i.e., the National Cancer Institute's smartphone app QuitGuide (QG).

Detailed Description
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This is a nation-wide proof-of-concept randomized controlled trial conducted entirely remotely. Participation will last 6 months and entails: Completing a scripted onboarding call (approximately 30-45 minutes) Making a quit attempt Engaging with smoking cessation support (randomized) over the course of seven weeks, one week prior and 6 weeks following the originally chosen quit day Completing five online, REDCap-administered surveys, administered prior to the quit day (online, as part of a screening test), and at 2-week, 6-week, 3-month, and 6-month follow-ups of the participant's chosen quit day The Aims of the study are: Test for differences between randomized groups on the primary outcome (i.e., self-efficacy to remain abstinent, as measured via the Smoking Self-Efficacy Questionnaire), as measured at end of treatment (i.e., 6 weeks after the participants' chosen smoking quit day) Test for differences between randomized groups on secondary outcomes (as listed in Detailed Protocol) (exploratory) To test, via mediational modeling, how treatment via the proposed app conferred benefit; or, if not effective, if failure is due to the treatment failing to impact hypothesized mechanisms of change, or because these mechanisms fail to impact outcome.

Official Title
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A Proof-of-concept RCT of Version 3.0 of the Smoking Cessation Smartphone App Smiling Instead of Smoking (SiS)

Conditions
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Nondaily Smoking

Intervention / Treatment
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* Behavioral: Smartphone app Smiling instead of Smoking (SiS) Version 3
* Behavioral: Smartphone app QuitGuide (QG)
* Behavioral: Brochure Clearing the Air (CTA)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18+ years of age smartphone ownership (Android or iPhone only) current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days lifetime history of having smoked 100+ cigarettes willing to make a smoking quit attempt currently residing in the United States of America Exclusion Criteria: Under 18 years of age Does not own an Android or iPhone Is not a nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days Does not have a lifetime history of having smoked 100+ cigarettes Is not willing to make a smoking quit attempt Is not currently residing in the United States of America

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3-group proof-of-concept RCT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SiS<br>Participants will be onboarded (remotely) to the smartphone app Smiling instead of Smoking (SiS), and will be asked to use it for 7 weeks while they quit smoking. | Behavioral: Smartphone app Smiling instead of Smoking (SiS) Version 3<br>* Participants will be onboarded to the smartphone app SiS and will be asked to use it for 7 weeks to support them in quitting smoking.<br>* Other names: SiS;|
| Active Comparator: QG<br>Participants will be onboarded (remotely) to the smartphone app QuitGuide (QG), and will be asked to use it for 7 weeks while they quit smoking. | Behavioral: Smartphone app QuitGuide (QG)<br>* Participants will be onboarded to the NCI smartphone app QG and will be asked to use it for 7 weeks to support them in quitting smoking.<br>* Other names: QG;|
| Other: CTA<br>Participants will be onboarded (remotely) to the NCI brochure Clearing the Air (CTA), and will be asked to use it for 7 weeks while they quit smoking. | Behavioral: Brochure Clearing the Air (CTA)<br>* Participants will be onboarded to the brochure Clearing the Air and will be asked to use it for 7 weeks to support them in quitting smoking.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking Self-Efficacy Questionnaire (SEQ) | The Smoking Self-Efficacy Questionnaire (SEQ-12) (Etter, Bergman, Humair, & Perneger, 2000) is a two-dimensional 12-item self-report scale measuring a person's confidence in his or her ability to abstain from smoking when facing internal stimuli (e.g. feeling depressed) and external stimuli (e.g. being with smokers) on a 0-100 slider scale (i.e., 0=not at all confident that I can refrain; 100=extremely confident that I can refrain). Scale scores are created by mean scoring across items and range from 0 to 100. Higher scores indicate greater self-efficacy to abstain from smoking. | up to 24 weeks post quit day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported 30-day point-prevalence abstinence | Participants respond to the multiple choice question, what is your current smoking status? (I smoke daily, I smoke non-daily (and have smoked in the past 7 days), I smoke nondaily (but have NOT smoked in the past 7 days), I do not smoke at all). If participants report abstinence they are asked, have you been abstinent during the past 30 days? (yes/no). | up to 24 weeks post quit day | 
| Self-reported past week cigarette change | If participants report having smoked in the past 7 days, they will be asked to indicate how many cigarettes they smoked each day (Last Monday:, Last Sunday:). Changes in cigarette consumption will be calculated by subtracting the number of cigarettes smoked in the week leading up to the baseline assessment, as measured in the baseline survey, from the number of cigarettes smoked in the week leading up to the 2, 6, 12, and 24 week assessments, as assessed in these respective surveys. | up to 24 weeks post quit day | 
| Satisfaction with smoking cessation support | As measured using the Client Satisfaction Scale (CSQ-8) (Larsen, 1979), an 8 item multiple choice measure that will be used to assess participants' satisfaction with the smoking cessation support they receive (e.g., How satisfied are you with the amount of help you received?). Scores are summed across items and range from 8 to 32, with higher scores indicating greater satisfaction. | Assessed at treatment end (6-week) | 
| Time spent applying content brought up by the apps/Clearing the Air | Measured using the following single item, During this past week, how much time did you spend applying or contemplating the content of the SiS app/QG app/Clearing the Air? [in minutes]. | Assessed at treatment end (6-week) | 
| Use of smoking cessation strategies | Assessed using a 19-item measure in which participants rate the extent to which they agree or disagree with statements about the smoking cessation support they received and the things they did while quitting (5-point Likert scale, 1=strongly disagree, 5=strongly agree, eg, I used techniques to help me relax). Higher scores indicate greater use of smoking cessation strategies. | Assessed at treatment end (6-week) | 
| Perceived impact of the provided materials on quitting | Participants provide their level of agreement (5-point Likert scale, 1=strongly disagree, 5=strongly agree) on 17 items pertaining to the helpfulness of the app during the quitting process (eg, risky situations, take my quit attempt seriously, prepare for the quit attempt). Higher scores indicate a greater perceived impact of the materials on quitting. Participants also indicate if the app helped them in their quit attempt and if they would recommend it to a friend who wants to quit smoking (yes/no). | Assessed at treatment end (6-week) | 
| Appreciation | As measured using the Appreciation Scale, (Adler & Fagley, 2005) an 18-item scale assessing the degree to which one is appreciative. Ten of the items assess frequency of action (e.g., I do things to remind myself to be thankful 7-point Likert: 1 = More than once a day, 2 = About once a day, 3 = About once a week, 4 = About once a month, 5 = About once a year, 6 = A few times in my life, 7 = Never). The remaining eight items assess level of agreement with appreciative statements (e.g., I feel that it is a miracle to be alive 7-point Likert: 1 = Strongly agree, 2 = Agree, 3 = Agree somewhat, 4 = Neither agree nor disagree, 5= Disagree somewhat, 6 = Disagree, 7 = Strongly disagree). Scale scores are created by mean scoring and range from 1 to 7 with higher scores indicating greater appreciation. | Assessed at treatment end (6-week) | 
| Actual app usage (SiS and QG only) | Number of days participants used the assigned app during the prescribed period of app use (i.e., 7 weeks for both apps). App usage is passively recorded by the app, which time-stamps every interaction with the app. | up to 24 weeks post quit day | 
| Self-reported app usage (SiS and QG only) | Number of days used app, asked per week; if used, how many minutes per typical day used app | up to 6 weeks post quit day | 
| Likability rating of the app (SiS and QG only) | Measured using the single item, How much did you like using the smoking cessation app we asked you to use? Participants respond on a 5-point Likert scale (1 = I strongly disliked using the app, 2 = I somewhat disliked using the app, 3 = I neither liked nor disliked using the app; 4 = I somewhat liked using the app, and 5 = I strongly liked using the app). | Assessed at treatment end (6-week) | 
| Satisfaction rating of the smoking cessation support (SiS and QG only) | Measured using the single item, How satisfied are you with the smoking cessation support this app provided you with? Participants respond on a 5-point Likert scale (1 = very unsatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, 5 = very satisfied). | Assessed at treatment end (6-week) | 
| App usability ratings (SiS and QG only) | As assessed via the System Usability Scale (SUS; Brooke, 1996), a ten-item attitude scale giving a global view of subjective assessments of usability, adapted to include language specific to the smoking app (e.g., I found the smoking app unnecessarily complex 5-point Likert: 1 = strongly disagree, 5 = strongly agree). Scale scores range from 0 to 100 with greater scores indicating a more favorable perception of usability of the app. | Assessed at treatment end (6-week) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SiS, positive psychology, mHealth, nondaily smoking, smartphone app, smoking cessation, QuitGuide, Smiling instead of Smoking