Cigarette Smoking-Related Carcinoma
Conditions
Brief summary
This study evaluates the effects of a video game embedded in a commercially available mobile application (app) for smoking cessation. Smokers are increasingly turning to mobile health apps for assistance with quitting smoking, and there is a critical need for strategies to engage app users to increase retention and efficacy. Video games are designed to increase users' motivation and engagement, which in turn may increase their exposure and adherence to a smoking cessation program. The hypothesis is that the game increases engagement, retention, and smoking abstinence rates compared with a core version of the app without the game. A two-arm individually randomized pilot trial of 500 adult smokers will test this hypothesis, comparing outcomes for participants randomized to receive the core app plus embedded game with participants randomized to receive the core app only. Primary outcomes relate to user engagement with the app. Secondary outcomes relate to user engagement, efficacy (smoking abstinence), and user satisfaction.
Detailed description
PRIMARY OBJECTIVES: I. Augment an existing smartphone cessation app for smoking cessation with a video game to increase user engagement. II. Test the feasibility, engagement, and early efficacy of the 'gamified' app, compared to one without gamification. OUTLINE: Participants are recruited through the Smoke Free smartphone app and randomized to 1 of 2 arms. ARM I: Participants receive an educational intervention through the Smoke Free application (core app) with the embedded video game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up. ARM II: Participants receive an educational intervention through the Smoke Free application without the video game module (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up.
Interventions
BEHAVIORALGame Module
Receive access to the the game module through the free, 'Smoke Free' smartphone application
BEHAVIORALSmoke Free smartphone application
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)
Sponsors
National Cancer Institute (NCI)
National Institute on Aging (NIA)
University of California, Berkeley
Johns Hopkins University
University of California, San Francisco
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. Provides electronic informed consent. 2. Male or female, aged 18 and older 3. Has downloaded and opened the Smoke Free app 4. A smoker of at least 1 cigarette per day 5. Plans to quit smoking within the next 7 days 6. Speaks, reads, and writes English 7. Lives in the United States
Exclusion criteria
None
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Unique App Sessions | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | Number of times the app was opened; passively collected by the app and averaged in analysis to calculate mean number of app opens by study group over the study period. A new session is defined as use of the app after at least 30 minutes of inactivity. |
| Minutes of App Usage Per Session | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | Passively collected by the app and averaged in analysis among those with a session to calculate mean number of minutes of usage per session by study group. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Self-reported 30-day Point-prevalence Abstinence at 2 Months | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, assuming missing = smoking. |
| Unique Days With at Least One App Session | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | Number of unique days with at least one app session, passively collected by the app and averaged by study group. |
| Satisfaction With Game (Intervention Group Only) | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Rating of satisfaction with the game on a 5-point Likert scale from Not at all (1) to Extremely (5), assessed in the 2-month follow-up questionnaire. The measure is averaged for the intervention group. |
| Satisfaction With App | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Rating of satisfaction with assigned app on a 5-point Likert scale from Not at all (1) to Extremely (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group. |
| Self-reported 7-day Point-prevalence Abstinence at 2 Months | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Proportion of participants who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, assuming missing = smoking. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Motivation to Quit | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Motivation to quit, reported on a 10-point scale from not at all motivated (0) to very unmotivated (10) and assessed in the 2-month follow-up. |
| Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Proportion of participants who who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, verified by saliva cotinine test, assuming missing = smoking. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 7-day window during repeated measurement of daily smoking in the app. |
| Digital Therapeutic Alliance | 56 days after participant's selected quit date (56 to 63 days after enrollment) | The measure includes items from the Bonding and Confidence subscales from the Mobile Agnew Relationship Measure, a scale of digital therapeutic alliance. Two items from each of the Bonding and Confidence subscales were included. Each item was asked on a 4-point Likert scale from strongly disagree (1) to strongly agree (4). The subscale items were combined to give a total possible score of 16 and a range of 4 (low alliance) to 16 (high alliance). The measure is averaged by study group. Assessed in the 2-month follow-up. |
| Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, verified by saliva cotinine test, assuming missing = smoking. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 30-day window during repeated measurement of daily smoking in the app. |
| Repeated 1-day Point-prevalence Smoking Abstinence | During the 56 days after participant's selected quit date | Proportion of days in which participants self-report having abstained in the last 24 hours, collected via a pop-up box that appears the first time each day a participant opens the app. Averaged by study group. |
| Program Adherence (Index of Core Feature Use) | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | Number of non-game (core app) activities completed in the app by activity type: passively collected by the app to assess number of times the participant completed the following activity types: reported a craving, recorded a diary, completed a mission, read a tip, used the chatbot. |
| Gifts Unlocked (Intervention Group Only) | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | Number of in-game gifts unlocked during the study period (intervention group only); a summary measure of intensity of engagement (dose of treatment) of the app; passively collected by the app. |
| Game Activities (Intervention Group Only) | Enrollment through 56 days after participant's selected quit date (56 to 63 days total) | Number of game activities completed in the app by activity type; passively collected by the app to assess number of times the participant completed the following activity types: navigated to the game dashboard, completed each pet care activity (breathing exercise, feeding, washing, memory mini-game), visited the park, entered the dragon guide. |
| Recommends App to Friend | 56 days after participant's selected quit date (56 to 63 days after enrollment) | Rating of whether would recommend assigned app to a friend on a 5-point Likert scale from Not at all (1) to Extremely (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Educational Intervention Plus Game Module Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application, as well as the integrated game module. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance.
Game module: Receive free access to the the Inner Dragon game module integrated into the Smoke Free smartphone application. In the Inner Dragon game, users care for a customizable pet dragon. that evolves in tandem with the user's progress in quitting smoking. The game includes several key features: 1) the dragon hatches on the user's quit day and evolves every 7 days to unlock new attributes and powers; 2) users earn experience points by using selected core app features; 3) users maintain care meters that change when the dragon is fed or pet; 4) the game provides tools for the user to better cope with the challenges of withdrawal, such as a breathing exercise to provide calmness and a memory minigame as a distraction; and 5) users can asynchronously interact with other users' dragons in a dragon park. | 241 |
| Educational Intervention Only Participants receive free access to an educational intervention consisting of the core features of the Smoke Free application only. Participants complete questionnaires and are invited to completed remote saliva sample collection if they report being smoke-free at follow-up.
Smoke Free educational intervention: Receive free access to core features of the Smoke Free smartphone application, including a calculator that tracks time elapsed since quitting smoking, progress indicators regarding predicted health improvements, daily tasks to avoid and resist urges to smoke, and a text-based chatbot that delivers smoking cessation guidance. | 238 |
| Total | 479 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Did not finish the onboarding process within the Smoke Free app prior to learning their allocation | 10 | 11 |
Baseline characteristics
| Characteristic | Educational Intervention Plus Game Module | Educational Intervention Only | Total |
|---|---|---|---|
| Age, Continuous | 38 years | 35 years | 36 years |
| Cigarettes per day | 15 cigarettes | 15 cigarettes | 15 cigarettes |
| Educational attainment Bachelor's or associate degree | 83 Participants | 68 Participants | 151 Participants |
| Educational attainment Graduate degree | 20 Participants | 31 Participants | 51 Participants |
| Educational attainment High school diploma or less | 45 Participants | 55 Participants | 100 Participants |
| Educational attainment Some college or technical school | 93 Participants | 84 Participants | 177 Participants |
| Fagerström Test for Nicotine Dependence | 5 units on a scale | 5 units on a scale | 5 units on a scale |
| Frequency played video games in last 6 months At least monthly but not weekly | 26 Participants | 25 Participants | 51 Participants |
| Frequency played video games in last 6 months At least weekly but not every day | 49 Participants | 40 Participants | 89 Participants |
| Frequency played video games in last 6 months Every day | 73 Participants | 89 Participants | 162 Participants |
| Frequency played video games in last 6 months Less than once a month | 36 Participants | 25 Participants | 61 Participants |
| Frequency played video games in last 6 months Not at all | 57 Participants | 59 Participants | 116 Participants |
| Household income, categorical Between $20,000 and $40,000 | 63 Participants | 65 Participants | 128 Participants |
| Household income, categorical Between $40,000 and $60,000 | 51 Participants | 51 Participants | 102 Participants |
| Household income, categorical Between $60,000 and $80,000 | 32 Participants | 24 Participants | 56 Participants |
| Household income, categorical Between $80,000 and $100,000 | 21 Participants | 18 Participants | 39 Participants |
| Household income, categorical Less than $20,000 | 35 Participants | 35 Participants | 70 Participants |
| Household income, categorical More than $100,000 | 39 Participants | 45 Participants | 84 Participants |
| Past quit attempts | 4 attempts | 4 attempts | 4 attempts |
| Race/Ethnicity, Customized Race and ethnicity Hispanic | 19 Participants | 9 Participants | 28 Participants |
| Race/Ethnicity, Customized Race and ethnicity Non-Hispanic Black | 22 Participants | 26 Participants | 48 Participants |
| Race/Ethnicity, Customized Race and ethnicity Non-Hispanic White | 186 Participants | 182 Participants | 368 Participants |
| Race/Ethnicity, Customized Race and ethnicity Other | 14 Participants | 21 Participants | 35 Participants |
| Sex/Gender, Customized Gender Female | 177 Participants | 181 Participants | 358 Participants |
| Sex/Gender, Customized Gender Male | 59 Participants | 55 Participants | 114 Participants |
| Sex/Gender, Customized Gender Non-binary or other | 5 Participants | 2 Participants | 7 Participants |
| Used electronic nicotine device systems in last 30 days | 57 Participants | 61 Participants | 118 Participants |
| Used nicotine replacmeent therapy in last 30 days | 56 Participants | 43 Participants | 99 Participants |
| Years since initiated smoking | 19 years | 16 years | 18 years |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 241 | 0 / 238 |
| other Total, other adverse events | 3 / 241 | 7 / 239 |
| serious Total, serious adverse events | 0 / 241 | 0 / 238 |
Outcome results
Primary
Minutes of App Usage Per Session
Passively collected by the app and averaged in analysis among those with a session to calculate mean number of minutes of usage per session by study group.
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Minutes of App Usage Per Session | 6.9 minutes per session | Standard Deviation 5.4 |
| Educational Intervention Only | Minutes of App Usage Per Session | 6.1 minutes per session | Standard Deviation 5.2 |
Primary
Number of Unique App Sessions
Number of times the app was opened; passively collected by the app and averaged in analysis to calculate mean number of app opens by study group over the study period. A new session is defined as use of the app after at least 30 minutes of inactivity.
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Number of Unique App Sessions | 29.6 number of sessions | Standard Deviation 36.5 |
| Educational Intervention Only | Number of Unique App Sessions | 24.3 number of sessions | Standard Deviation 37.9 |
Secondary
Satisfaction With App
Rating of satisfaction with assigned app on a 5-point Likert scale from Not at all (1) to Extremely (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Population: Only those participants who completed the follow-up questionnaire are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Satisfaction With App | 3.7 units on a scale | Standard Deviation 1 |
| Educational Intervention Only | Satisfaction With App | 3.7 units on a scale | Standard Deviation 1.1 |
Secondary
Satisfaction With Game (Intervention Group Only)
Rating of satisfaction with the game on a 5-point Likert scale from Not at all (1) to Extremely (5), assessed in the 2-month follow-up questionnaire. The measure is averaged for the intervention group.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Population: Only those participants in the intervention group who completed the follow-up questionnaire are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Satisfaction With Game (Intervention Group Only) | 3.3 units on a scale | Standard Deviation 1.4 |
Secondary
Self-reported 30-day Point-prevalence Abstinence at 2 Months
Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, assuming missing = smoking.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Plus Game Module | Self-reported 30-day Point-prevalence Abstinence at 2 Months | 54 Participants |
| Educational Intervention Only | Self-reported 30-day Point-prevalence Abstinence at 2 Months | 50 Participants |
Secondary
Self-reported 7-day Point-prevalence Abstinence at 2 Months
Proportion of participants who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, assuming missing = smoking.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Plus Game Module | Self-reported 7-day Point-prevalence Abstinence at 2 Months | 94 Participants |
| Educational Intervention Only | Self-reported 7-day Point-prevalence Abstinence at 2 Months | 101 Participants |
Secondary
Unique Days With at Least One App Session
Number of unique days with at least one app session, passively collected by the app and averaged by study group.
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Unique Days With at Least One App Session | 14.3 days with a session | Standard Deviation 15.3 |
| Educational Intervention Only | Unique Days With at Least One App Session | 11.9 days with a session | Standard Deviation 13.3 |
Other Pre-specified
Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months
Proportion of participants who who self-report having abstained for the prior 30 days during the 2-month follow-up assessment, verified by saliva cotinine test, assuming missing = smoking. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 30-day window during repeated measurement of daily smoking in the app.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Plus Game Module | Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months | 19 Participants |
| Educational Intervention Only | Biochemically Verified 30-day Point-prevalence Abstinence at 2 Months | 31 Participants |
Other Pre-specified
Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months
Proportion of participants who who self-report having abstained for the prior 7 days during the 2-month follow-up assessment, verified by saliva cotinine test, assuming missing = smoking. Averaged by study group. Recoded to 0 if the person reported having smoked during the same 7-day window during repeated measurement of daily smoking in the app.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Educational Intervention Plus Game Module | Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months | 27 Participants |
| Educational Intervention Only | Biochemically Verified 7-day Point-prevalence Abstinence at 2 Months | 37 Participants |
Other Pre-specified
Digital Therapeutic Alliance
The measure includes items from the Bonding and Confidence subscales from the Mobile Agnew Relationship Measure, a scale of digital therapeutic alliance. Two items from each of the Bonding and Confidence subscales were included. Each item was asked on a 4-point Likert scale from strongly disagree (1) to strongly agree (4). The subscale items were combined to give a total possible score of 16 and a range of 4 (low alliance) to 16 (high alliance). The measure is averaged by study group. Assessed in the 2-month follow-up.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Population: Only those participants who completed the questions in the follow-up questionnaire are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Digital Therapeutic Alliance | 12.7 units on a scale | Standard Deviation 2.2 |
| Educational Intervention Only | Digital Therapeutic Alliance | 12.8 units on a scale | Standard Deviation 2.5 |
Other Pre-specified
Game Activities (Intervention Group Only)
Number of game activities completed in the app by activity type; passively collected by the app to assess number of times the participant completed the following activity types: navigated to the game dashboard, completed each pet care activity (breathing exercise, feeding, washing, memory mini-game), visited the park, entered the dragon guide.
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Population: Applicable to intervention group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Game Activities (Intervention Group Only) | 123.1 number of game features used | Standard Deviation 285 |
Other Pre-specified
Gifts Unlocked (Intervention Group Only)
Number of in-game gifts unlocked during the study period (intervention group only); a summary measure of intensity of engagement (dose of treatment) of the app; passively collected by the app.
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Population: In-game gifts available for intervention group only.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Gifts Unlocked (Intervention Group Only) | 3.3 number of gifts unlocked | Standard Deviation 6.9 |
Other Pre-specified
Motivation to Quit
Motivation to quit, reported on a 10-point scale from not at all motivated (0) to very unmotivated (10) and assessed in the 2-month follow-up.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Population: Only those participants who completed the question in the follow-up questionnaire are included in the analysis population. A programming error led to missing data for most respondents who reported having continued to smoke.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Motivation to Quit | 9.3 units on a scale | Standard Deviation 1.3 |
| Educational Intervention Only | Motivation to Quit | 9.4 units on a scale | Standard Deviation 1.5 |
Other Pre-specified
Program Adherence (Index of Core Feature Use)
Number of non-game (core app) activities completed in the app by activity type: passively collected by the app to assess number of times the participant completed the following activity types: reported a craving, recorded a diary, completed a mission, read a tip, used the chatbot.
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Program Adherence (Index of Core Feature Use) | 19.0 number of core features used | Standard Deviation 28.2 |
| Educational Intervention Only | Program Adherence (Index of Core Feature Use) | 15.6 number of core features used | Standard Deviation 29.1 |
Other Pre-specified
Recommends App to Friend
Rating of whether would recommend assigned app to a friend on a 5-point Likert scale from Not at all (1) to Extremely (5), assessed in the 2-month follow-up questionnaire. The measure is averaged by study group.
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Population: Only those participants who completed the follow-up questionnaire are included in the analysis population.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Recommends App to Friend | 3.8 units on a scale | Standard Deviation 1.1 |
| Educational Intervention Only | Recommends App to Friend | 4.0 units on a scale | Standard Deviation 1.1 |
Other Pre-specified
Repeated 1-day Point-prevalence Smoking Abstinence
Proportion of days in which participants self-report having abstained in the last 24 hours, collected via a pop-up box that appears the first time each day a participant opens the app. Averaged by study group.
Time frame: During the 56 days after participant's selected quit date
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Educational Intervention Plus Game Module | Repeated 1-day Point-prevalence Smoking Abstinence | 17.3 percentage of days | Standard Deviation 25.6 |
| Educational Intervention Only | Repeated 1-day Point-prevalence Smoking Abstinence | 12.4 percentage of days | Standard Deviation 21.3 |