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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2018-02662 | Registry Identifier | NCI / CTRP | |
| RG1001191 | Other Identifier | Fred Hutch/University of Washington Cancer Consortium | |
| R01CA192849 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Washington | OTHER |
| National Cancer Institute (NCI) | NIH |
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The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | This is the experimental arm of the study. This includes receiving the novel/experimental smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study. |
|
| Control | Active Comparator | This is the control arm of the study. This includes receiving the standard of care smartphone smoking cessation app. Therapy description withheld to protect the integrity of the study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone-delivered Intervention (SmartQuit) | Behavioral | The experimental arm includes an intervention using a novel smartphone smoking cessation app. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Point Prevalence Abstinence, Complete-case | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants. | 12 months post randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 30-day Point Prevalence Abstinence, Missing=Smoking Imputation | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants. | 12 months post randomization |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jonathan Bricker, Ph.D. | Fred Hutchinson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutchinson Cancer Research Center | Seattle | Washington | 98109 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40963258 | Derived | Santiago-Torres M, Mull KE, Shi D, Alexander AC, Nollen NL, Sullivan BM, Zvolensky MJ, Bricker JB. Intersectionality in cigarette smoking cessation: A latent class analysis to predict 12-month cessation in a randomized controlled trial. Addiction. 2026 Jan;121(1):173-185. doi: 10.1111/add.70185. Epub 2025 Sep 17. | |
| 39889280 | Derived | Santiago-Torres M, Mull KE, Sullivan BM, Cupertino AP, Salloum RG, Triplette M, Zvolensky MJ, Bricker JB. Evaluating the Impact of Pharmacotherapy in Augmenting Quit Rates Among Hispanic Adults in an App-Delivered Smoking Cessation Intervention: Secondary Analysis of a Randomized Controlled Trial. JMIR Form Res. 2025 Jan 31;9:e69311. doi: 10.2196/69311. |
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Smokers were recruited from May 27, 2017 to September 28, 2018, nationally via Facebook ads, a survey sampling company, search engine results, and referral from friends and family.
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| ID | Title | Description |
|---|---|---|
| FG000 | Experimental | Novel/experimental intervention smartphone smoking cessation app iCanQuit. |
| FG001 | Control | Standard of care control smoking cessation app QuitGuide from NCI. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 3 Month Follow-up Survey |
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| |||||||||||||||||||||
| 6 Month Follow-up Survey |
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| 12 Month Follow-up Survey |
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Participants not excluded as ineligible after randomization
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| ID | Title | Description |
|---|---|---|
| BG000 | Experimental | Novel/experimental intervention smartphone smoking cessation app iCanQuit. |
| BG001 | Control | Standard of care control smoking cessation app QuitGuide from NCI. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 30-day Point Prevalence Abstinence, Complete-case | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants. | Participants who reported 30-day point prevalence abstinence at 12 months post-treatment and who were not excluded as ineligible after randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months post randomization |
|
Approximately 31 months, from the opening of the recruitment window to closure of the data collection window.
This is a smartphone-delivered behavioral intervention, so there were no known risks for serious adverse events, other adverse events, or all-cause mortality.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Experimental | Novel/experimental intervention smartphone smoking cessation app iCanQuit. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Jonathan Bricker | Fred Hutchinson Cancer Research Center | 206-667-5077 | jbricker@fredhutch.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 18, 2018 | Nov 5, 2020 | ICF_000.pdf |
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 5, 2018 | Nov 5, 2020 | Prot_SAP_001.pdf |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D016540 | Smoking Cessation |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D015438 | Health Behavior |
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| : Smartphone-delivered Intervention (Standard of care app) | Behavioral | The control intervention uses a standard of care smartphone smoking cessation app. |
|
| 39845432 | Derived | Santiago-Torres M, Mull KE, Sullivan BM, Prochaska JJ, Zvolensky MJ, Bricker JB. Can an Acceptance and Commitment Therapy-Based Smartphone App Help Individuals with Mental Health Disorders Quit Smoking? Depress Anxiety. 2024;2024:1055801. doi: 10.1155/2024/1055801. Epub 2024 Jun 21. |
| 37943594 | Derived | Santiago-Torres M, Mull KE, Sullivan BM, Bricker JB. Use of e-Cigarettes in Cigarette Smoking Cessation: Secondary Analysis of a Randomized Controlled Trial. JMIR Mhealth Uhealth. 2023 Nov 9;11:e48896. doi: 10.2196/48896. |
| 35420700 | Derived | Jackson S, Brown J, Norris E, Livingstone-Banks J, Hayes E, Lindson N. Mindfulness for smoking cessation. Cochrane Database Syst Rev. 2022 Apr 14;4(4):CD013696. doi: 10.1002/14651858.CD013696.pub2. |
| 35257698 | Derived | Santiago-Torres M, Mull KE, Sullivan BM, Ferketich AK, Bricker JB. Efficacy of an acceptance and commitment therapy-based smartphone application for helping rural populations quit smoking: Results from the iCanQuit randomized trial. Prev Med. 2022 Apr;157:107008. doi: 10.1016/j.ypmed.2022.107008. Epub 2022 Mar 4. |
| 35026491 | Derived | Santiago-Torres M, Mull KE, Sullivan BM, Kendzor DE, Bricker JB. Efficacy and utilization of smartphone applications for smoking cessation among low-income adults: Secondary analysis of the iCanQuit randomized trial. Drug Alcohol Depend. 2022 Feb 1;231:109258. doi: 10.1016/j.drugalcdep.2021.109258. Epub 2021 Dec 31. |
| 34890104 | Derived | Santiago-Torres M, Mull KE, Sullivan BM, Kwon D, Nollen NL, Zvolensky MJ, Bricker JB. Efficacy and utilization of an acceptance and commitment therapy-based smartphone application for smoking cessation among Black adults: secondary analysis of the iCanQuit randomized trial. Addiction. 2022 Mar;117(3):760-771. doi: 10.1111/add.15721. Epub 2021 Dec 9. |
| 34751662 | Derived | Bricker JB, Levin M, Lappalainen R, Mull K, Sullivan B, Santiago-Torres M. Mechanisms of Smartphone Apps for Cigarette Smoking Cessation: Results of a Serial Mediation Model From the iCanQuit Randomized Trial. JMIR Mhealth Uhealth. 2021 Nov 9;9(11):e32847. doi: 10.2196/32847. |
| 32955554 | Derived | Bricker JB, Watson NL, Mull KE, Sullivan BM, Heffner JL. Efficacy of Smartphone Applications for Smoking Cessation: A Randomized Clinical Trial. JAMA Intern Med. 2020 Nov 1;180(11):1472-1480. doi: 10.1001/jamainternmed.2020.4055. |
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| NOT COMPLETED |
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| BG002 | Total | Total of all reporting groups |
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Smoking level | Count of Participants | Participants |
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| Education level | Count of Participants | Participants |
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| CESD-20 Depression Screen | Center for Epidemiological Studies Depression 20-item Scale (CESD-20). The range of possible CESD-20 scores is 0-60, with higher values indicating increased symptom severity. | Analysis population includes participants who sufficiently completed the CESD-20 items. | Count of Participants | Participants |
|
Standard of care control smoking cessation app QuitGuide from NCI.
|
|
|
| Secondary | 30-day Point Prevalence Abstinence, Missing=Smoking Imputation | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants. | Participants who were not excluded as ineligible after randomization. | Posted | Number | 95% Confidence Interval | Percentage of participants | 12 months post randomization |
|
|
|
|
| 0 |
| 1,214 |
| 0 |
| 1,214 |
| 0 |
| 1,214 |
| EG001 | Control | Standard of care control smoking cessation app QuitGuide from NCI. | 0 | 1,201 | 0 | 1,201 | 0 | 1,201 |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|