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Clinical Trial NCT07493252 for Cigarette Smoking-Related Carcinoma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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A Behavioral Application for Improving Smoking Cessation Among Smokers 1,812
Clinical Trial NCT07493252 is an interventional study for Cigarette Smoking-Related Carcinoma and is currently not yet recruiting. Enrollment is planned to begin on 1 August 2026 and continue until the study accrues 1,812 participants. Led by Fred Hutchinson Cancer Center, this study is expected to complete by 31 July 2029. The latest data from ClinicalTrials.gov was last updated on 25 March 2026.
Brief Summary
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 gu...Show More
Detailed Description
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,...
Show MoreOfficial Title
Actify! An mHealth Mood Management Tool to Improve Population-Level Smoking Cessation
Conditions
Cigarette Smoking-Related CarcinomaOther Study IDs
NCT ID Number
Start Date (Actual)
2026-08-01
Last Update Posted
2026-03-25
Completion Date (Estimated)
2029-07-31
Enrollment (Estimated)
1,812
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Primary Purpose
Prevention
Design Allocation
Randomized
Interventional Model
Parallel
Masking
Single
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalArm I (Actify! A app) 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. | Smartphone app-based Intervention (Actify! A app) Use Actify! A app Health Promotion and Education Receive motivational messages and smoking cessation information via text messages Survey Administration Ancillary studies |
Active ComparatorArm II (Actify! B app) 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. | Smartphone app-based Intervention (Actify! B app) Use Actify! B app Health Promotion and Education Receive motivational messages and smoking cessation information via text messages Survey Administration Ancillary studies |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | 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 |
| Outcome Measure | 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 | 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 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
Accepts Healthy Volunteers
Yes
- Age 18 or older
- Currently smoke, averaging at least 5 cigarettes/day for the last 30 days
- Interested in quitting smoking in the next 30 days
- Experience downloading and using one or more apps on their smartphone
- Either screens negative for depression (Patient Health Questionnaire - 9 item \[PHQ-9\] score 0-4; n = 906) or screens positive for mild to moderately severe current depressive symptoms (PHQ-9 score 5-19; n = 906)
- Willing and able to complete all study activities and to receive compensation by mail
- Comfortable reading and writing in English
- Have a mobile data plan and/or access to WiFi to support the use of the assigned app
- Reside in the United States (US)
- Willing to provide information for an emergency contact in case of serious concerns about the participant's physical or mental health
- Self-report of currently receiving behavioral treatment for depression (e.g., psychotherapy or counseling, web- or app-based interventions); current use of pharmacotherapy for depression or for other mental health conditions that are not otherwise excluded is allowable (e.g., benzodiazepines, anticonvulsants, opioid agonists, antipsychotics)
- Severe depression (PHQ-9 ≥ 20)
- Current suicidal ideation reported on the PHQ-9
- History of a suicide attempt
- Self-reported lifetime diagnosis of bipolar disorder, schizophrenia, schizoaffective disorder, antisocial personality disorder, or borderline personality disorder; or self-reported lifetime diagnosis of an alcohol or drug use disorder with use of the substance(s) in the past 30 days
- Currently receiving other smoking cessation treatments, including pharmacotherapies (nicotine replacement therapy, bupropion, or varenicline) and behavioral interventions (e.g. quitline counseling, other digital health programs), but excluding electronic (e)-cigarettes/vaping
- Previous use of the QuitGuide program
- Employees/family of investigator or study center
- Member of the same household as another participant
- Woman who is pregnant or breastfeeding, or planning to become pregnant
- Having a Google voice number as their primary phone number (due to association with fraudulent study entry attempts in our previous work)
- Currently incarcerated
- Participated in earlier studies to develop the Actify! app
Fred Hutchinson Cancer CenterNational Institute on Drug Abuse (NIDA)Study Central Contact
Contact: Jaimee Heffner, PhD, 206-667-7314, [email protected]
1 Study Locations in 1 Countries
Washington
Fred Hutch/University of Washington Cancer Consortium, Seattle, Washington, 98109, United States
Jaimee Heffner, PhD, Contact, 206-667-7314, [email protected]
Jaimee Heffner, PhD, Principal Investigator