Smoking &Amp; Tobacco Cessation
Conditions
Keywords
Smoking, smoking cessation, quitting smoking, chatbot
Brief summary
This phase III trial compares two remote digital smoking cessation programs to see how well they work for quitting smoking.
Detailed description
OUTLINE: Participants are randomized to 1 of 2 groups. Both groups receive access to a 42-day quit smoking program. GROUP I: Experimental QuitBot chatbot program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months. GROUP II: Control SmokefreeTXT text messaging program, for 42 days to support quitting smoking. After the completion of study, patients are followed up at 3, 6, and 12 months.
Interventions
OTHERExperimental Smoking Cessation Program
Participate in Quitbot experimental cessation program
OTHERControl Smoking Cessation Program
Participate in Quitbot control cessation program
Sponsors
Fred Hutchinson Cancer Center
National Cancer Institute (NCI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age 18 or older * Smokes at least one cigarette a day for the past 12 months * Wants to quit cigarette smoking within the next 30 days (consistent with text messaging intervention trials) * If concurrently using any other nicotine or tobacco products, wants to quit using them within the next 30 days * Interested in learning skills to quit smoking * Willing to be randomly assigned to either intervention * Resides in United States (US) and will continue to reside in the US for the next 12 months * Has at least daily access to their own smartphone * Has text messaging on their smartphone and knows how to download a smartphone application * Willing and able to read in English, and * Not using other smoking cessation interventions (This eligibility requirement helps ensure results are due to the treatments we recommend rather than those that participants are doing on their own.)
Exclusion criteria
* The reverse of the inclusion criteria
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 30-day Cigarette Smoking Cessation | At 12 months after randomization | The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 12 months post-randomization. At 12 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With 30-day Cigarette Smoking Cessation | At 6 months after randomization | The primary endpoint is 30-day point prevalence abstinence for cigarette smoking at 6 months post-randomization. At 6 months, smoking abstinence is assessed by asking participants: "When was the last time you smoked, or even tried, a cigarette?" Response choices are "Earlier today", "24 hours ago", "2-7 days ago", "8-30 days ago", and "Over 30 days ago". Participants reporting no cigarette consumption in the past 30 days are considered abstinent for the 30-day outcome. Missing outcome data are handled using standard intent-to-treat analysis, with all missing data coded as smoking. |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORJonathan B. Bricker
Fred Hutch/University of Washington Cancer Consortium
Participant flow
Recruitment details
Adults who smoke were recruited nationally from 07/24/2022 to 01/25/2024 via Facebook ads, search engine results, and referral from friend and family.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 42.4 Years STANDARD_DEVIATION 9.8 |
| CESD-20 Depression Screen CESD-20 score greater than or equal to 16 | 639 Participants |
| CESD-20 Depression Screen CESD-20 score less than 16 | 196 Participants |
| Education Level High school or less education | 621 Participants |
| Education Level Some college or more education | 530 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 82 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 775 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 27 Participants |
| Race (NIH/OMB) Asian | 6 Participants |
| Race (NIH/OMB) Black or African American | 108 Participants |
| Race (NIH/OMB) More than one race | 49 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 2 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 20 Participants |
| Race (NIH/OMB) White | 638 Participants |
| Sex/Gender, Customized Sex: Female, Male Female | 504 Participants |
| Sex/Gender, Customized Sex: Female, Male Male | 312 Participants |
| Sex/Gender, Customized Sex: Female, Male Unknown | 6 Participants |
| Smoking Level 10 or fewer cigarettes per day | 637 Participants |
| Smoking Level 11-20 cigarettes per day | 805 Participants |
| Smoking Level 21 or more cigarettes per day | 205 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 821 | 0 / 826 |
| other Total, other adverse events | 0 / 821 | 0 / 826 |
| serious Total, serious adverse events | 0 / 821 | 0 / 826 |
Outcome results
None listed