Smoking
Conditions
Keywords
smoking cessation, app for quitting smoking
Brief summary
The goal of this study is to determine whether the novel smartphone app (SmartQuit) provides higher quit rates than the current standard smoking cessation app.
Interventions
BEHAVIORALSmartphone-delivered Intervention (SmartQuit)
The experimental arm includes an intervention using a novel smartphone smoking cessation app.
BEHAVIORAL: Smartphone-delivered Intervention (Standard of care app)
The control intervention uses a standard of care smartphone smoking cessation app.
Sponsors
University of Washington
National Cancer Institute (NCI)
Fred Hutchinson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* age 18 or older * smokes at least five cigarettes daily for at least past 12 months * wants to quit cigarette smoking in the next 30 days * 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 condition * resides in US * has at least daily access to their own personal Apple iPhone, Android, or Windows Phone * knows how to login and download a smartphone application * willing and able to read in English * not using other smoking cessation interventions (including apps or our other intervention studies). * willing to complete all three follow-up surveys * provide email, phone, and mailing address.
Exclusion criteria
* The
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Point Prevalence Abstinence, Complete-case | 12 months post randomization | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 30-day Point Prevalence Abstinence, Missing=Smoking Imputation | 12 months post randomization | Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants. |
Countries
United States
Participant flow
Recruitment details
Smokers were recruited from May 27, 2017 to September 28, 2018, nationally via Facebook ads, a survey sampling company, search engine results, and referral from friends and family.
Participants by arm
| Arm | Count |
|---|---|
| Experimental Novel/experimental intervention smartphone smoking cessation app iCanQuit. | 1,214 |
| Control Standard of care control smoking cessation app QuitGuide from NCI. | 1,201 |
| Total | 2,415 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12 Month Follow-up Survey | Excluded as ineligible after randomization | 40 | 48 |
| 12 Month Follow-up Survey | Lost to Follow-up | 174 | 134 |
| 3 Month Follow-up Survey | Excluded as ineligible after randomization | 40 | 48 |
| 3 Month Follow-up Survey | Lost to Follow-up | 171 | 151 |
| 6 Month Follow-up Survey | Excluded as ineligible after randomization | 40 | 48 |
| 6 Month Follow-up Survey | Lost to Follow-up | 156 | 123 |
Baseline characteristics
| Characteristic | Control | Experimental | Total |
|---|---|---|---|
| Age, Continuous | 38.3 Years STANDARD_DEVIATION 11 | 38.2 Years STANDARD_DEVIATION 10.8 | 38.2 Years STANDARD_DEVIATION 10.9 |
| CESD-20 Depression Screen CESD-20 score greater than 15 | 583 Participants | 583 Participants | 1166 Participants |
| CESD-20 Depression Screen CESD-20 score less than or equal to 15 | 614 Participants | 625 Participants | 1239 Participants |
| Education level High school or less education | 495 Participants | 500 Participants | 995 Participants |
| Education level Some college or more education | 706 Participants | 714 Participants | 1420 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 105 Participants | 105 Participants | 210 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 1096 Participants | 1109 Participants | 2205 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 30 Participants | 28 Participants | 58 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 5 Participants | 6 Participants |
| Race (NIH/OMB) Black or African American | 232 Participants | 234 Participants | 466 Participants |
| Race (NIH/OMB) More than one race | 84 Participants | 89 Participants | 173 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 21 Participants | 20 Participants | 41 Participants |
| Race (NIH/OMB) White | 830 Participants | 836 Participants | 1666 Participants |
| Sex: Female, Male Female | 843 Participants | 857 Participants | 1700 Participants |
| Sex: Female, Male Male | 358 Participants | 357 Participants | 715 Participants |
| Smoking level 20 or fewer cigarettes per day | 962 Participants | 965 Participants | 1927 Participants |
| Smoking level 21 or more cigarettes per day | 239 Participants | 249 Participants | 488 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 1,214 | 0 / 1,201 |
| other Total, other adverse events | 0 / 1,214 | 0 / 1,201 |
| serious Total, serious adverse events | 0 / 1,214 | 0 / 1,201 |
Outcome results
Primary
30-day Point Prevalence Abstinence, Complete-case
Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are excluded for the complete-case analysis. Exact 2-sided CI was based on the observed proportion of participants.
Time frame: 12 months post randomization
Population: Participants who reported 30-day point prevalence abstinence at 12 months post-treatment and who were not excluded as ineligible after randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | 30-day Point Prevalence Abstinence, Complete-case | 28.2 Percentage of participants |
| Control | 30-day Point Prevalence Abstinence, Complete-case | 21.1 Percentage of participants |
p-value: <0.00195% CI: [1.22, 1.83]Regression, Logistic
Secondary
30-day Point Prevalence Abstinence, Missing=Smoking Imputation
Percentage of participants reporting no smoking in the past 30 days, 12 months post-treatment. Participants missing follow-up data are imputed as still smoking. Exact 2-sided CI was based on the observed proportion of participants.
Time frame: 12 months post randomization
Population: Participants who were not excluded as ineligible after randomization.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Experimental | 30-day Point Prevalence Abstinence, Missing=Smoking Imputation | 24.1 Percentage of participants |
| Control | 30-day Point Prevalence Abstinence, Missing=Smoking Imputation | 18.7 Percentage of participants |
p-value: 0.00195% CI: [1.14, 1.71]Regression, Logistic