Version 2 of the Smoking Cessation Smartphone App "Smiling Instead of Smoking" (SiS)

NCT ID: NCT03951766

Last Updated: 2022-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-24
• Study Completion Date: 2020-06-08

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.

Conditions

Smoking Cessation; Smoking, Tobacco

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Smiling Instead of Smoking App

This is a pilot study; all participants will use the app in the same manner/time period.

Group Type: OTHER

Smiling Instead of Smoking (SiS) App Version 2

Intervention Type: BEHAVIORAL

The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.

Interventions

Smiling Instead of Smoking (SiS) App Version 2

The investigators have developed a smartphone app that acts as a behavioral, in-the-pocket coach and uses positive psychology exercises to enhance quitting success. It is anonymous, portable, and provides just-in-time support, an important feature for smokers who smoke under specific conditions and circumstances. To support treatment, investigators use a positive psychology approach. The smartphone app administers positive psychology exercises to enhance and/or maintain positive affect, which is hypothesized to stimulate nondaily smokers to enact healthier alternatives to smoking by broadening their thought-action repertoire, increasing confidence, and decreasing craving and defensiveness about smoking-related health information.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

American Cancer Society, Inc.

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Bettina B. Hoeppner

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Bettina B Hoeppner, PhD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

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Provided Documents

Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form

View Document

Other Identifiers

2018P002699

Identifier Type: -

Identifier Source: org_study_id