Cigarette Smoking-Related CarcinomaPhase 1NCT04525222
mHealth Mood Management Tool (Actify) to Improve Population-Level Smoking Cessation
A Phase 1 study testing Health Promotion and Education, Smoking Cessation Intervention (Actify app) and Survey Administration in people with Cigarette Smoking-Related Carcinoma, run by Fred Hutchinson Cancer Center at 1 site in United States.
Trial summary
This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone… 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?
- Health Promotion and Education, Smoking Cessation Intervention (Actify app) and Survey Administration
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 1 siteUnited States
- Study dates
- 9 May 2022to 12 Apr 2023
- Phase
- Phase 1
- 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
- Current smoker, 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 (Patient Health Questionnaire - 9 Item [PHQ-9] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
- Willing and able to complete all study activities
- Comfortable reading and writing in English
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- Have a mobile data plan and/or access to WiFi to support the use of the Actify app
- Reside in the US
- Have a smartphone either an iPhone (running iOS version 11 or higher) or an Android phone (running version 5.0 or higher)
Who cannot join
- Currently receiving behavioral treatment for depression (e.g., psychotherapy)
- Current use of a depression app
- Severe depression (PHQ-9 >= 20)
- Receiving other treatment for smoking cessation
- Previous use of the QuitGuide app
- Current or recent (within the past year) enrollment in a Fred Hutch smoking cessation study
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- 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
- Currently incarcerated
- Is ineligible per fraud prevention protocol
Trial locations and contacts
1 site in 1 country.
United States1 site
Fred Hutch/University of Washington Cancer Consortium
Seattle, Washington, 98109
About this study
Official title: An mHealth Mood Management Tool to Improve Population-Level Cessation
This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.
Read the detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
After completion of study, participants are followed up at 6 months.
- Conditions
- Cigarette Smoking-Related Carcinoma
- Being tested
- Health Promotion and Education, Smoking Cessation Intervention (Actify app), Smoking Cessation Intervention (Current Standard Care app), Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health Promotion and EducationOther
Receive motivational messages and smoking cessation information via text notifications
Smoking Cessation Intervention (Actify app)Behavioural
Also called Smoking and Tobacco Use Cessation Interventions
Use Actify app
Smoking Cessation Intervention (Current Standard Care app)Behavioural
Also called Smoking and Tobacco Use Cessation Interventions
Use (USCPG) Current Standard Care app
Survey AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Arm I (Actify, text notifications) | Experimental | Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Receives: Other: Health Promotion and Education; Behavioral: Smoking Cessation Intervention (Actify app); Other: Survey Administration |
| Arm II (Current Standard Care, text notifications) | Active comparator | Participants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. Receives: Other: Health Promotion and Education; Behavioral: Smoking Cessation Intervention (Current Standard Care app); Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction.
Measured: At 8 weeks post-randomization
Application (App) Utilization
Number of app openings during the 8-week treatment period.
Measured: At 8 weeks post-randomization
Secondary outcomes (14)
Biochemically-confirmed 30-day PPA From Smoking
Self-reported 30-day smoking abstinence at 8 weeks, confirmed via expired carbon monoxide (CO<6ppm)
Measured: At 8 weeks post-randomization
Self-reported 30-day PPA From Smoking
Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"
Measured: At 6 months post-randomization
Biochemically-confirmed 30-day PPA From Smoking
Self-reported 30-day smoking abstinence at 6 months, confirmed via expired carbon monoxide (CO<6 ppm)
Measured: At 6 months post-randomization
Self-reported 7-day PPA From Smoking
Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"
Measured: At 8 weeks post-randomization
Biochemically Confirmed 7-day PPA From Smoking
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm)
Measured: At 8 weeks post-randomization
Self-reported 7-day PPA From Smoking
Self-reported 7-day abstinence on the survey question of "When was the last time you smoked, or even tried, a cigarette?"
Measured: At 6 months post-randomization
Biochemically Confirmed 7-day PPA From Smoking
Self-reported 7-day abstinence from smoking, confirmed via expired carbon monoxide (CO < 6ppm)
Measured: At 6 months post-randomization
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported 30-day abstinence on the survey questions of "Have you smoked at all, even a puff, in the last 30 days?" \& "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" \& "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?"
Measured: At 8 weeks post-randomization
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm)
Measured: At 8 weeks post-randomization
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported 30-day abstinence on survey questions of "Have you smoked at all, even a puff, in the last 30 days?" \& "In the last 30 days, how often did you use any kind of e-cigarette or vaping product?" \& "In the last 30 days, how often did you use any other tobacco products such as chewing tobacco, snus, hookahs, cigars, cigarillos, tobacco pipes, and kreteks?"
Measured: At 6 months post-randomization
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Self-reported abstinence from cigarettes and other non-medicinal nicotine/tobacco products, including e-cigarettes, confirmed via at home saliva cotinine test and expired carbon monoxide (CO < 6ppm)
Measured: At 6 months post-randomization
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)
The Patient Health Questionnaire-8 (PHQ-8) is an assessment of depressive symptoms used to detect symptom changes over time as a result of treatment. The PHQ-8 asks the number of days in the past 2 weeks the respondent had experienced a particular depressive symptom. Possible answers are "not at all" or "several days" or "more than half the days" or "nearly every day," with points (0 to 3) assigned to each category. The scores for each item are summed to produce a total score between 0 and 24 points. A total score of 0 to 4 represents no significant depressive symptoms. A total score of 5 to 9 represents mild depressive symptoms; 10 to 14, moderate; 15 to 19, moderately severe; and 20 to 24, severe.
Measured: Baseline to 8 weeks
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking
Self-reported 30-day abstinence on the survey question of "Have you smoked at all, even a puff, in the last 30 days?"
Measured: At 8 weeks post-randomization
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)
The Behavioral Activation for Depression Scale (BADS) is a 25-item scale used to track changes in behaviors hypothesized to underlie depression and specifically targeted for change by behavioral activation. BADS items are rated on a 7-point scale ranging from 0 (not at all) to 6 (completely). The behavioral activation subscale contains 7 items, with a scoring range of 0 to 42. Change scores reflect the value of the BADS behavioral activation subscale score at 8-week follow-up minus the baseline score. Positive change values indicate an increase in behavioral activation (i.e, an improvement), whereas negative scores indicate a decrease in behavioral activation.
Measured: Baseline to 8 weeks 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 Aug 2020
- Study start9 May 2022
- Primary completion19 Dec 2022
- Study completion12 Apr 2023
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.
- Other trials for Cigarette Smoking-Related CarcinomaStudies of the same condition, open and under way.
- More trials run by Fred Hutchinson Cancer CenterThe 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 242 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fred Hutchinson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Jaimee Heffner, Fred Hutchinson Cancer Center
- Investigators
- Jaimee Heffner, Principal investigator, Fred Hutch/University of Washington Cancer Consortium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04525222
- Sponsor's protocol ID
- RG1121054
- Other IDs
- NCI-2020-05454, 10540, R34DA050967
- Status last verified
- Mar 2024
- First submitted
- 13 Aug 2020
- Last updated
- 7 Mar 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An mHealth Mood Management Tool to Improve Population-Level Cessation
- ClinicalTrials.gov ID
- NCT04525222
- Acronym / sponsor ID
- RG1121054
- Conditions
- Cigarette Smoking-Related Carcinoma
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 242 participants (actual)
- Lead sponsor
- Fred Hutchinson Cancer CenterUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- 9 May 2022 (actual)
- Primary completion
- 19 Dec 2022 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 25 Aug 2020 (actual)
- Results
- Posted 7 Mar 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This phase I trial investigates a new smartphone application (called Actify) for improving population-level smoking cessation and mood management. Actify delivers behavioral activation therapy for depression as part of a smoking cessation intervention and will be compared to another smoking cessation smartphone application that is based on current clinical practice guidelines. Participants will be randomly assigned to receive one of two smartphone applications and accompanying text notifications to help with quitting smoking and improved mood.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 arms.
ARM I: Participants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
ARM II: Participants use United States (US) Clinical Practice Guidelines (USCPG) app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications.
After completion of study, participants are followed up at 6 months.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (Actify, text notifications) | Experimental | Other: Health Promotion and Education, Behavioral: Smoking Cessation Intervention (Actify app), Other: Survey AdministrationParticipants use Actify app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. |
| Arm II (Current Standard Care, text notifications) | Active comparator | Other: Health Promotion and Education, Behavioral: Smoking Cessation Intervention (Current Standard Care app), Other: Survey AdministrationParticipants use app for smoking cessation for 8 weeks. Participants also receive motivational messages and smoking cessation information via text notifications. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Current smoker, 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 (Patient Health Questionnaire - 9 Item [PHQ-9] score 0-4) for depression or screens positive for mild to moderate current depressive symptoms (PHQ-9 score 5-19)
- Willing and able to complete all study activities
Key exclusion criteria (11 listed)
- Currently receiving behavioral treatment for depression (e.g., psychotherapy)
- Current use of a depression app
- Severe depression (PHQ-9 >= 20)
- Receiving other treatment for smoking cessation
- Previous use of the QuitGuide app
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 |
|---|---|---|
| Health Promotion and EducationReceive motivational messages and smoking cessation information via text notifications | Other | Arm I (Actify, text notifications), Arm II (Current Standard Care, text notifications) |
| Smoking Cessation Intervention (Actify app)Also: Smoking and Tobacco Use Cessation InterventionsUse Actify app | Behavioural | Arm I (Actify, text notifications) |
| Smoking Cessation Intervention (Current Standard Care app)Also: Smoking and Tobacco Use Cessation InterventionsUse (USCPG) Current Standard Care app | Behavioural | Arm II (Current Standard Care, text notifications) |
| Survey AdministrationAncillary studies | Other | Arm I (Actify, text notifications), Arm II (Current Standard Care, text notifications) |
Primary outcome
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey
Time frame: At 8 weeks post-randomization
Overall treatment satisfaction is reported on a Likert-type scale, with response choices ranging from "not at all=1" to "very much=5". Higher values are associated with higher level of satisfaction.
Application (App) Utilization
Time frame: At 8 weeks post-randomization
Number of app openings during the 8-week treatment period.
14 secondary outcomes
Biochemically-confirmed 30-day PPA From Smoking
Time frame: At 8 weeks post-randomization
Self-reported 30-day PPA From Smoking
Time frame: At 6 months post-randomization
Biochemically-confirmed 30-day PPA From Smoking
Time frame: At 6 months post-randomization
Self-reported 7-day PPA From Smoking
Time frame: At 8 weeks post-randomization
Biochemically Confirmed 7-day PPA From Smoking
Time frame: At 8 weeks post-randomization
Self-reported 7-day PPA From Smoking
Time frame: At 6 months post-randomization
Biochemically Confirmed 7-day PPA From Smoking
Time frame: At 6 months post-randomization
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Time frame: At 8 weeks post-randomization
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Time frame: At 8 weeks post-randomization
Self-reported 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Time frame: At 6 months post-randomization
Biochemically Confirmed 30-day PPA From Smoking Cigarettes and Other Non-medicinal Nicotine/Tobacco Products, Including E-cigarettes
Time frame: At 6 months post-randomization
Change in Depressive Symptoms Via Patient Health Questionnaire-8 (PHQ-8)
Time frame: Baseline to 8 weeks
Self-reported 30-day Point Prevalence Abstinence (PPA) From Smoking
Time frame: At 8 weeks post-randomization
Change in Behavioral Activation Subscale Score on the Behavioral Activation for Depression Scale (BADS)
Time frame: Baseline to 8 weeks post-randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jaimee Heffner 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 Phase 1 study testing Health Promotion and Education, Smoking Cessation Intervention (Actify app) and Survey Administration 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 9 inclusion and 11 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 7 Mar 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 7 Mar 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?
Overall Satisfaction With Assigned Treatment on the Treatment Satisfaction Survey (time frame: At 8 weeks post-randomization). 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?
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 7 Mar 2024.