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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2025-09044 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| U01DA062241 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute on Drug Abuse (NIDA) | NIH |
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This clinical trial compares two smartphone applications, called Actify! (A & B) for improving smoking cessation outcomes in individuals who smoke. Actify! A is an app grounded in behavioral activation therapy, an evidence-based treatment for depression that can also be used to modify health behaviors such as smoking. The Actify! B app provides evidence-based tobacco cessation strategies based on current clinical guidelines.
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use the Actify! A app, which helps users identify personal values and meaningful activities, prompts users to schedule and complete meaningful activities, visualizes progress towards meeting activity and smoking-related goals, and provides tailored messages, resources, daily tips, personalized feedback, inspirational messages, and user stories, for 8 weeks on study.
ARM II: Participants use the Actify! B app, which contains quit advice, tools for tracking smokefree days, progress and cravings, guidance on preparing to quit, managing cravings and withdrawal, recovering from slips, and a mood management feature, for 8 weeks on study.
After completion of study intervention, participants are followed up at 6 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm I (Actify! A app) | Experimental | Participants use the Actify! app, which helps users identify personal values and meaningful activities, prompts users to schedule and complete meaningful activities, visualizes progress towards meeting activity and smoking-related goals, and provides tailored messages, resources, daily tips, personalized feedback, inspirational messages, and user stories, for 8 weeks on study. |
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| Arm II (Actify! B app) | Active Comparator | Participants use an app, which contains quit advice, tools for tracking smokefree days, progress and cravings, guidance on preparing to quit, managing cravings and withdrawal, recovering from slips, and a mood management feature, for 8 weeks on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smartphone app-based Intervention (Actify! A app) | Behavioral | Use Actify! A app |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking | Percentage of participants self-reporting no smoking over the previous 30 days | At 6 months post-randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Biochemically-confirmed 30-day PPA from cigarette smoking | Percentage of participants reporting no smoking over the previous 30 days, confirmed via carbon monoxide testing | At 6 months post-randomization |
| Self-reported 7-day PPA from cigarette smoking |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaimee Heffner, PhD | Contact | 206-667-7314 | jheffner@fredhutch.org |
| Name | Affiliation | Role |
|---|---|---|
| Jaimee Heffner, PhD | Fred Hutch/University of Washington Cancer Consortium | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fred Hutch/University of Washington Cancer Consortium | Seattle | Washington | 98109 | United States |
The study researchers for this study plan to preserve and share the following:
Documentation made publicly available to the research community will include PDFs of various study materials.
At this time, the study researchers plan to share scientific data and meta-data in NCI's Cancer Data Service (CDS): https://dataservice.datacommons.cancer.gov/#/home.
Final data submission and release of data used in publications will occur at the time of publication. Other shared data will be made available at or before the end of the project period. The study researchers will follow the data retention plan of the final selected repository, but at a minimum, researchers intend to ensure that data is available for a period of not less than 5 years after the end of this trial.
All data sharing will be done in compliance with NIH data sharing policies, applicable laws and regulations, and in accordance with guidance from journal publishers. CDS allows open and controlled access to data to ensure access is provided to qualified researchers, data access is tracked, and users understand how to cite and credit use of the data. Data will only be shared for non-profit, non-commercial and non-proprietary purposes to qualified researchers or as allowed by CDS. Based on the nature of the data, which is not sensitive, the study researchers anticipate making it publicly available (as opposed to controlled access) but will follow final recommendations from the IRB as to whether access should be controlled.
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| Smartphone app-based Intervention (Actify! B app) |
| Behavioral |
Use Actify! B app |
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| Health Promotion and Education | Other | Receive motivational messages and smoking cessation information via text messages |
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| Survey Administration | Other | Ancillary studies |
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Percentage of participants reporting no cigarette smoking over the prior 7 days |
| At 8 weeks post-randomization |
| Self-reported 7-day PPA from cigarette smoking | Percentage of participants reporting no cigarette smoking over the prior 7 days | At 6 months post-randomization |
| Self-reported 7-day PPA from use of all nicotine/tobacco products except Food and Drug Administration (FDA)-approved medications | Percentage of participants reporting no smoking over the prior 7 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum) | At 8 weeks post-randomization |
| Self-reported 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications | Percentage of participants reporting no smoking over the prior 7 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum) | At 6 months post-randomization |
| Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications | Percentage of participants reporting no smoking over the prior 30 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum) | At 8 weeks post-randomization |
| Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications | Percentage of participants reporting no smoking over the prior 30 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum) | At 6 months post-randomization |
| Biochemically confirmed 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications | Percentage of participants reporting no smoking over the prior 7 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum), confirmed via carbon monoxide and cotinine testing | At 6 months post-randomization |
| Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications | Percentage of participants reporting no smoking over the prior 30 days and no use of any other nicotine/tobacco product except FDA-approved medications (e.g, nicotine patch or gum), confirmed via carbon monoxide and cotinine testing | At 6 months post-randomization |
| ID | Term |
|---|---|
| D006293 | Health Promotion |
| D004522 | Educational Status |
| ID | Term |
|---|---|
| D006266 | Health Education |
| D011314 | Preventive Health Services |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
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