Cigarette Smoking-Related CarcinomaNCT05227027
Pilot Trial of a Game Embedded in a Smartphone App for Smoking Cessation
A study testing Game Module and Smoke Free smartphone application in people with Cigarette Smoking-Related Carcinoma, run by University of California, San Francisco at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoking-Related Carcinoma
- What is being tested?
- Game Module and Smoke Free smartphone application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2022to 31 May 2022
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Provides electronic informed consent.
- Male or female, aged 18 and older
- Has downloaded and opened the Smoke Free app
- A smoker of at least 1 cigarette per day
- Plans to quit smoking within the next 7 days
- Speaks, reads, and writes English
- Lives in the United States
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California San Francisco
San Francisco, California, 94143
About this study
Official title: Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Game Module, Smoke Free smartphone application
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Game ModuleBehavioural
Also called In-application game module
Receive access to the the game module through the free, 'Smoke Free' smartphone application
Smoke Free smartphone applicationBehavioural
Also called Educational intervention
Receive educational intervention through the free 'Smoke Free' smartphone application (core version of the app)
| Study group | Role | What they receive |
|---|---|---|
| Education plus game module | Experimental | Participants receive an educational intervention through the Smoke Free application with the embedded game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up. Receives: Behavioral: Game Module; Behavioral: Smoke Free smartphone application |
| Education module only | Active comparator | Participants receive an educational intervention through the Smoke Free application only (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up. Receives: Behavioral: Smoke Free smartphone application |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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.
Measured: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Secondary outcomes (5)
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.
Measured: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
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.
Measured: 56 days after participant's selected quit date (56 to 63 days after enrollment)
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.
Measured: 56 days after participant's selected quit date (56 to 63 days after enrollment)
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.
Measured: 56 days after participant's selected quit date (56 to 63 days after enrollment)
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.
Measured: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2022
- Study start9 Feb 2022
- Primary completion31 May 2022
- Study completion31 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Aging (NIA), University of California, Berkeley, Johns Hopkins University
- Responsible party
- Sponsor
- Investigators
- Justin White, PhD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05227027
- Sponsor's protocol ID
- 19-29335
- Other IDs
- NCI-2021-07004, P30AG012839, R21CA238301
- Status last verified
- Nov 2023
- First submitted
- 26 Jan 2022
- Last updated
- 3 Jan 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
White JS, Salem MK, Toussaert S, Westmaas JL, Raiff BR, Crane D, Warrender E, Lyles C, Abroms L, Thrul J. Developing a Game (Inner Dragon) Within a Leading Smartphone App for Smoking Cessation: Design and Feasibility Evaluation Study. JMIR Serious Games. 2023 Aug 11;11:e46602. doi: 10.2196/46602.
PubMed 37566442White JS, Toussaert S, Raiff BR, Salem MK, Chiang AY, Crane D, Warrender E, Lyles CR, Abroms LC, Westmaas JL, Thrul J. Evaluating the Impact of a Game (Inner Dragon) on User Engagement Within a Leading Smartphone App for Smoking Cessation: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 30;26:e57839. doi: 10.2196/57839.
PubMed 39475840
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Game Embedded in a Smartphone App for Smoking Cessation on User Engagement: A Randomized Pilot Trial
- ClinicalTrials.gov ID
- NCT05227027
- Acronym / sponsor ID
- 19-29335
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Institute on Aging (NIA), University of California, Berkeley, Johns Hopkins University
- Study start
- 9 Feb 2022 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 7 Feb 2022 (actual)
- Results
- Posted 3 Jan 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Education plus game module | Experimental | Behavioral: Game Module, Behavioral: Smoke Free smartphone applicationParticipants receive an educational intervention through the Smoke Free application with the embedded game module. Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up. |
| Education module only | Active comparator | Behavioral: Smoke Free smartphone applicationParticipants receive an educational intervention through the Smoke Free application only (core app only). Participants complete questionnaires and may undergo saliva sample collection, if they report being smoke-free on follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Provides electronic informed consent.
- Male or female, aged 18 and older
- Has downloaded and opened the Smoke Free app
- A smoker of at least 1 cigarette per day
- Plans to quit smoking within the next 7 days
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Game ModuleAlso: In-application game moduleReceive access to the the game module through the free, 'Smoke Free' smartphone application | Behavioural | Education plus game module |
| Smoke Free smartphone applicationAlso: Educational interventionReceive educational intervention through the free 'Smoke Free' smartphone application (core version of the app) | Behavioural | Education module only, Education plus game module |
Primary outcome
Number of Unique App Sessions
Time frame: 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
Time frame: 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.
5 secondary outcomes
Unique Days With at Least One App Session
Time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)
Self-reported 7-day Point-prevalence Abstinence at 2 Months
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Self-reported 30-day Point-prevalence Abstinence at 2 Months
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Satisfaction With App
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Satisfaction With Game (Intervention Group Only)
Time frame: 56 days after participant's selected quit date (56 to 63 days after enrollment)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 37566442White JS, Salem MK, Toussaert S, Westmaas JL, Raiff BR, Crane D, Warrender E, Lyles C, Abroms L, Thrul J. Developing a Game (Inner Dragon) Within a Leading Smartphone App for Smoking Cessation: Design and Feasibility Evaluation Study. JMIR Serious Games. 2023 Aug 11;11:e46602. doi: 10.2196/46602.
- Derived from this study: PubMed 39475840White JS, Toussaert S, Raiff BR, Salem MK, Chiang AY, Crane D, Warrender E, Lyles CR, Abroms LC, Westmaas JL, Thrul J. Evaluating the Impact of a Game (Inner Dragon) on User Engagement Within a Leading Smartphone App for Smoking Cessation: Randomized Controlled Trial. J Med Internet Res. 2024 Oct 30;26:e57839. doi: 10.2196/57839.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Justin White, PhD principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Game Module and Smoke Free smartphone application in people with Cigarette Smoking-Related Carcinoma, run by University of California, San Francisco at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Unique App Sessions (time frame: Enrollment through 56 days after participant's selected quit date (56 to 63 days total)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05227027, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jan 2024.