Cigarette Smoking-Related CarcinomaNCT07493252
A Behavioral Application for Improving Smoking Cessation Among Smokers
A study testing Smartphone app-based Intervention (Actify! A app), Smartphone app-based Intervention (Actify! B app) and Health Promotion and Education in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial 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… 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?
- Smartphone app-based Intervention (Actify! A app), Smartphone app-based Intervention (Actify! B app) and Health Promotion and Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,812 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 31 Jul 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- 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
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- 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
Who cannot join
- 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
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- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
Jaimee Heffner, PhD, 206-667-7314, jheffner@fredhutch.org
Jaimee Heffner, PhD
About this study
Official title: Actify! An mHealth Mood Management Tool to Improve Population-Level Smoking Cessation
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.
Read the 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, 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.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Smartphone app-based Intervention (Actify! A app), Smartphone app-based Intervention (Actify! B app), Health Promotion and Education, Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smartphone app-based Intervention (Actify! A app)Behavioural
Use Actify! A app
Smartphone app-based Intervention (Actify! B app)Behavioural
Use Actify! B app
Health Promotion and EducationOther
Receive motivational messages and smoking cessation information via text messages
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Smartphone app-based Intervention (Actify! A app); Other: Health Promotion and Education; Other: Survey Administration |
| 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. Receives: Behavioral: Smartphone app-based Intervention (Actify! B app); Other: Health Promotion and Education; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking
Percentage of participants self-reporting no smoking over the previous 30 days
Measured: At 6 months post-randomization
Secondary outcomes (9)
Biochemically-confirmed 30-day PPA from cigarette smoking
Percentage of participants reporting no smoking over the previous 30 days, confirmed via carbon monoxide testing
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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
Measured: At 6 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Jul 2029 (estimated)
- Study completion31 Jul 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 1,812 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Sponsor
- Investigators
- Jaimee Heffner, PhD, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07493252
- Sponsor's protocol ID
- RG1126036
- Other IDs
- NCI-2025-09044, U01DA062241
- Status last verified
- Mar 2026
- First submitted
- 20 Mar 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The study researchers for this study plan to preserve and share the following: * Survey Data: De-identified individual and aggregate survey data (including raw and recoded data) necessary to replicate main outcomes will be shared. The de-identification process will remove direct and indirect respondent identifiers prior to sharing. * App utilization data: Individual level, de-identified aggregate data necessary to replicate main outcomes (e.g., summary number of log-ins, pages viewed, or other app events) will be shared. The de-identification process will remove direct and indirect respondent identifiers. 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.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Actify! An mHealth Mood Management Tool to Improve Population-Level Smoking Cessation
- ClinicalTrials.gov ID
- NCT07493252
- Acronym / sponsor ID
- RG1126036
- Conditions
- Cigarette Smoking-Related Carcinoma
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,812 participants (estimated)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Jul 2029 (estimated)
- Study completion
- 31 Jul 2029 (estimated)
- First posted
- 25 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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, 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Actify! A app) | Experimental | Behavioral: Smartphone app-based Intervention (Actify! A app), Other: Health Promotion and Education, Other: Survey AdministrationParticipants 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. |
| Arm II (Actify! B app) | Active comparator | Behavioral: Smartphone app-based Intervention (Actify! B app), Other: Health Promotion and Education, Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
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 |
|---|---|---|
| Smartphone app-based Intervention (Actify! A app)Use Actify! A app | Behavioural | Arm I (Actify! A app) |
| Smartphone app-based Intervention (Actify! B app)Use Actify! B app | Behavioural | Arm II (Actify! B app) |
| Health Promotion and EducationReceive motivational messages and smoking cessation information via text messages | Other | Arm I (Actify! A app), Arm II (Actify! B app) |
| Survey AdministrationAncillary studies | Other | Arm I (Actify! A app), Arm II (Actify! B app) |
Primary outcome
Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking
Time frame: At 6 months post-randomization
Percentage of participants self-reporting no smoking over the previous 30 days
9 secondary outcomes
Biochemically-confirmed 30-day PPA from cigarette smoking
Time frame: At 6 months post-randomization
Self-reported 7-day PPA from cigarette smoking
Time frame: At 8 weeks post-randomization
Self-reported 7-day PPA from cigarette smoking
Time frame: 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
Time frame: At 8 weeks post-randomization
Self-reported 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications
Time frame: At 6 months post-randomization
Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications
Time frame: At 8 weeks post-randomization
Self-reported 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications
Time frame: At 6 months post-randomization
Biochemically confirmed 7-day PPA from use of all nicotine/tobacco products except FDA-approved medications
Time frame: At 6 months post-randomization
Biochemically confirmed 30-day PPA from use of all nicotine/tobacco products except FDA-approved medications
Time frame: At 6 months post-randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: Yes. The study researchers for this study plan to preserve and share the following: * Survey Data: De-identified individual and aggregate survey data (including raw and recoded data) necessary to replicate main outcomes will be shared. The de-identification process will remove direct and indirect respondent identifiers prior to sharing. * App utilization data: Individual level, de-identified aggregate data necessary to replicate main outcomes (e.g., summary number of log-ins, pages viewed, or other app events) will be shared. The de-identification process will remove direct and indirect respondent identifiers. 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.
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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.
Jaimee Heffner, PhD principal investigator
Fred Hutch/University of Washington Cancer Consortium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Smartphone app-based Intervention (Actify! A app), Smartphone app-based Intervention (Actify! B app) and Health Promotion and Education in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center 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 10 inclusion and 13 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: opening soon, as of the sponsor's last update on 12 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaimee Heffner, PhD (206-667-7314, jheffner@fredhutch.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported 30-day point prevalence abstinence (PPA) from cigarette smoking (time frame: At 6 months post-randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Aug 2026.