Clinical trial NCT03951766: Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
Official title: An Online Pilot Study of Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking Cessation
Smoking, Tobacco
Keywords: mHealth
smartphone
smoking cessation
app
happiness
positive psychology
nondaily smoking
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: American Cancer Society, Inc.
First posted: 2019-05-15
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study: all participants will use the smartphone app for a total of 7 weeks.
Primary purpose: TREATMENT

Brief summary: The overall goal of this pilot study is to solicit feedback from nondaily smokers looking for smoking cessation support online (n=90) about Version 2 of a smartphone app investigators designed to support smoking cessation, and to test if within-person theorized mechanisms of change are occurring as participants undergo the app-assisted quit attempt. Data sources will be passively collected smartphone app usage data, surveys and, in a sub-sample (n=20), online video-conference user feedback sessions. Results will be used to guide the design of Version 3.0 of the "Smiling Instead of Smoking" (SiS) smartphone app. Specifically, the aims of this study are to:

1. Assess ease-of-use and helpfulness of the app, as rated by app users 6 weeks after their chosen smoking cessation date
2. Test if within-person changes occur in theorized mechanisms of behavior change as nondaily smokers undergo a SiS app assisted quit attempt
3. Identify app features in need of improvement, as identified by passively recorded app usage patterns, REDCap open-ended survey items, and, in a sub-sample, user feedback sessions (n=20)

Detailed description: An estimated 90 participants will participate in this study based on the following eligibility criteria: (a) 18+ years of age, (b) smartphone ownership (c) current nondaily smoker, who smokes at least weekly, and no more than 25 out of the past 30 days (i.e., 71% of nondaily smokers), and (d) has current quit intention (i.e., 65-74% of nondaily smokers). Investigators will stop enrollment when n=90 participants have completed the primary endpoint of the study, which is the 6-week follow-up. This study will be conducted entirely remotely and will require a screening process prior to enrolling participants on the app.

Study participation will last 6 months, where surveys will be 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. Participants will use the app for a strongly encouraged period of 7 weeks (1 week before, 6 weeks following the quit attempt), and optional continued use thereafter.

Participants will complete two types of assessment: (1) surveys, and (2) (in a sub-sample) user feedback sessions conducted via phone and/or video-conference call. Potential participants will click-through to the study website. This website will explain that participants must call study staff in order to be phone-screened and to participate in the study. During the phone-screen, participants will be directed to complete an online survey via REDCap. If participants complete the survey and pass the screening test (e.g., correctly responding to reading-check items in the online survey), they choose a smoking cessation quit day, and schedule a phone call with study staff to enroll in the study. This enrollment phone call occurs 1 week prior to the chosen quit day. During this call, study staff will provide the link to download the app, and provide participants with an app-walkthrough. Thereafter, participants will receive survey links for 2-week, 6-week, 3-month and 6-month follow-ups via an emailed link.

Participation in the user feedback session is optional. Within the baseline survey, participants will be asked if they would be willing to participate in an online video-conference user feedback session after they have used the app for seven weeks (1 week pre, 6 weeks post their chosen smoking quit day). If selected for the online user feedback sessions (selected at random from interested participants, with stratification based on gender, age, and race/ethnicity), participants will receive an email and/or phone call upon completing their 6-week survey to set up the user feedback session.

The online user feedback sessions (n=20) will consist of the participants, and 1-2 members of the study staff. Relatively little guidance will be provided in this setting. Instead, 4 open-ended questions will be posed (i.e., did the app help you in your quit attempt? What did you like? What did you dislike? How could the app be improved?). All conference calls will be recorded for later analysis.

Sample size and Power Considerations: The primary goal of this study is to gather qualitative input rather than data to detect a pre-specified effect. The goal of this pilot study is to get input from app users who are interacting with the app and study staff completely remotely, without the benefit of in-person interaction, which is closer to the real-world experience potential users would have than the participants in Study 1.

Planned Analyses:

Aim 1 (Ease-of-use and usefulness). To assess the degree to which SiS Version 2 is easy to use and perceived as useful by nondaily smokers attempting to quit smoking, investigators will use the Week 6 survey data, and will calculate means and standard deviations for the survey items querying ease of use and usefulness for each feature of the app.

Aim 2 (Within-person changes). To test if nondaily smokers utilizing SiS Version 2 experienced changes over time on constructs theorized to underlie smoking cessation, investigators will use the online survey data and fit one repeated measures mixed effects model per construct of interest (i.e., desire to smoke, mood, self-efficacy to quit/stay quit, motivation, outcome expectancies such as pros/cons, stress, coping), where the construct will be the dependent variable, and time (0=baseline, 1=2-week, 2=6-week, 3=3-month, 4=6-month) will be the predictor. Correlations over time will be modeled with an unstructured covariance matrix. The primary endpoint is 6 weeks post quit (i.e., end of treatment). A contrast statement will be used to compare baseline versus 6-week follow-up. Given the explorative nature of this study, investigators will not correct for multiple testing.

Aim 3 (Identify app features in need of improvement). To identify features of the app that are in need of improvement, investigators will examine the passively generated app usage data generated by study participants as they undergo their quit attempts, and will generate descriptive summary statistics on these usage data. To gain deeper insight, investigators will also conduct user feedback sessions with a randomly selected subsample of participants.

Eligibility criteria: Inclusion Criteria:

* Owns a smartphone
* Is a nondaily smoker, who smokes at least weekly and no more than 25 out of the past 30 days
* Has a current intention to quit smoking
* Interested in using a smartphone app to quit smoking

Exclusion Criteria:

* Under 18 years of age
* Does not own a smartphone
* 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 current intention to quit smoking
* Is not interested in using a smartphone app to quit smoking

Primary outcomes:
measure: Ease-of-use and Helpfulness of the App
timeFrame: 6 weeks after chosen smoking cessation date
Secondary outcomes:
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Questionnaire of Smoking Urges (Cox et al., 2001)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Urges Measure
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Positive and Negative Affect Schedule (Watson et al., 1988)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Subjective Happiness Scale (Lyubomirsky & Lepper, 1999)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Happiness Measures
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Self-Efficacy to Abstain From Smoking Questionnaire (Etter et al., 2000)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Self-efficacy Measure
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Motivation to Quit Measure
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Attitudes Towards Smoking Scale (Etter et al., 2000)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Commitment to Quitting Scale (Kahler et al., 2007)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Decisional Balance Inventory (DBI) for Smoking Short Form (Ward et al., 2004)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Single-item Pros/Cons of Quitting Smoking Measures
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Perceived Stress Scale (PSS) (Cohen, 1983)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
measure: Within-person Changes in Theorized Mechanism of Behavior Change - Brief Coping Orientation to Problems Experienced (Carver, 1997)
timeFrame: Baseline, 2-weeks, and 6-weeks post-quit
Other outcomes:
measure: Features of App That Need Improvement - App Usage
timeFrame: 6 weeks after chosen smoking cessation date
measure: Self-reported Smoking Status
timeFrame: Baseline, 2 weeks post-quit, 6 weeks post-quit, 3-months post-quit, 6-months post-quit
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Bettina B Hoeppner, PhD
role: PRINCIPAL_INVESTIGATOR
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