Trial Outcomes & Findings for Trial of An Innovative Smartphone Intervention for Smoking Cessation (NCT NCT02724462)
NCT ID: NCT02724462
Last Updated: 2021-01-05
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
2503 participants
Primary outcome timeframe
12 months post randomization
Results posted on
2021-01-05
Participant Flow
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.
Participant milestones
| Measure |
Experimental
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
|
Control
Standard of care control smoking cessation app QuitGuide from NCI.
|
|---|---|---|
|
3 Month Follow-up Survey
STARTED
|
1254
|
1249
|
|
3 Month Follow-up Survey
COMPLETED
|
1043
|
1050
|
|
3 Month Follow-up Survey
NOT COMPLETED
|
211
|
199
|
|
6 Month Follow-up Survey
STARTED
|
1254
|
1249
|
|
6 Month Follow-up Survey
COMPLETED
|
1058
|
1078
|
|
6 Month Follow-up Survey
NOT COMPLETED
|
196
|
171
|
|
12 Month Follow-up Survey
STARTED
|
1254
|
1249
|
|
12 Month Follow-up Survey
COMPLETED
|
1040
|
1067
|
|
12 Month Follow-up Survey
NOT COMPLETED
|
214
|
182
|
Reasons for withdrawal
| Measure |
Experimental
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
|
Control
Standard of care control smoking cessation app QuitGuide from NCI.
|
|---|---|---|
|
3 Month Follow-up Survey
Lost to Follow-up
|
171
|
151
|
|
3 Month Follow-up Survey
Excluded as ineligible after randomization
|
40
|
48
|
|
6 Month Follow-up Survey
Lost to Follow-up
|
156
|
123
|
|
6 Month Follow-up Survey
Excluded as ineligible after randomization
|
40
|
48
|
|
12 Month Follow-up Survey
Lost to Follow-up
|
174
|
134
|
|
12 Month Follow-up Survey
Excluded as ineligible after randomization
|
40
|
48
|
Baseline Characteristics
Analysis population includes participants who sufficiently completed the CESD-20 items.
Baseline characteristics by cohort
| Measure |
Experimental
n=1214 Participants
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
|
Control
n=1201 Participants
Standard of care control smoking cessation app QuitGuide from NCI.
|
Total
n=2415 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
38.2 Years
STANDARD_DEVIATION 10.8 • n=1214 Participants
|
38.3 Years
STANDARD_DEVIATION 11.0 • n=1201 Participants
|
38.2 Years
STANDARD_DEVIATION 10.9 • n=2415 Participants
|
|
Sex: Female, Male
Female
|
857 Participants
n=1214 Participants
|
843 Participants
n=1201 Participants
|
1700 Participants
n=2415 Participants
|
|
Sex: Female, Male
Male
|
357 Participants
n=1214 Participants
|
358 Participants
n=1201 Participants
|
715 Participants
n=2415 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
105 Participants
n=1214 Participants
|
105 Participants
n=1201 Participants
|
210 Participants
n=2415 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
1109 Participants
n=1214 Participants
|
1096 Participants
n=1201 Participants
|
2205 Participants
n=2415 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=1214 Participants
|
0 Participants
n=1201 Participants
|
0 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
28 Participants
n=1214 Participants
|
30 Participants
n=1201 Participants
|
58 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=1214 Participants
|
1 Participants
n=1201 Participants
|
6 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=1214 Participants
|
3 Participants
n=1201 Participants
|
5 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
Black or African American
|
234 Participants
n=1214 Participants
|
232 Participants
n=1201 Participants
|
466 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
White
|
836 Participants
n=1214 Participants
|
830 Participants
n=1201 Participants
|
1666 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
More than one race
|
89 Participants
n=1214 Participants
|
84 Participants
n=1201 Participants
|
173 Participants
n=2415 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
20 Participants
n=1214 Participants
|
21 Participants
n=1201 Participants
|
41 Participants
n=2415 Participants
|
|
Smoking level
21 or more cigarettes per day
|
249 Participants
n=1214 Participants
|
239 Participants
n=1201 Participants
|
488 Participants
n=2415 Participants
|
|
Smoking level
20 or fewer cigarettes per day
|
965 Participants
n=1214 Participants
|
962 Participants
n=1201 Participants
|
1927 Participants
n=2415 Participants
|
|
Education level
High school or less education
|
500 Participants
n=1214 Participants
|
495 Participants
n=1201 Participants
|
995 Participants
n=2415 Participants
|
|
Education level
Some college or more education
|
714 Participants
n=1214 Participants
|
706 Participants
n=1201 Participants
|
1420 Participants
n=2415 Participants
|
|
CESD-20 Depression Screen
CESD-20 score greater than 15
|
583 Participants
n=1208 Participants • Analysis population includes participants who sufficiently completed the CESD-20 items.
|
583 Participants
n=1197 Participants • Analysis population includes participants who sufficiently completed the CESD-20 items.
|
1166 Participants
n=2405 Participants • Analysis population includes participants who sufficiently completed the CESD-20 items.
|
|
CESD-20 Depression Screen
CESD-20 score less than or equal to 15
|
625 Participants
n=1208 Participants • Analysis population includes participants who sufficiently completed the CESD-20 items.
|
614 Participants
n=1197 Participants • Analysis population includes participants who sufficiently completed the CESD-20 items.
|
1239 Participants
n=2405 Participants • Analysis population includes participants who sufficiently completed the CESD-20 items.
|
PRIMARY outcome
Timeframe: 12 months post randomizationPopulation: Participants who reported 30-day point prevalence abstinence at 12 months post-treatment and who were not excluded as ineligible after 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.
Outcome measures
| Measure |
Experimental
n=1040 Participants
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
|
Control
n=1067 Participants
Standard of care control smoking cessation app QuitGuide from NCI.
|
|---|---|---|
|
30-day Point Prevalence Abstinence, Complete-case
|
28.2 Percentage of participants
Interval 25.5 to 31.0
|
21.1 Percentage of participants
Interval 18.7 to 23.7
|
SECONDARY outcome
Timeframe: 12 months post randomizationPopulation: Participants who were not excluded as ineligible after 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.
Outcome measures
| Measure |
Experimental
n=1214 Participants
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
|
Control
n=1201 Participants
Standard of care control smoking cessation app QuitGuide from NCI.
|
|---|---|---|
|
30-day Point Prevalence Abstinence, Missing=Smoking Imputation
|
24.1 Percentage of participants
Interval 21.8 to 26.7
|
18.7 Percentage of participants
Interval 16.6 to 21.1
|
Adverse Events
Experimental
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. Jonathan Bricker
Fred Hutchinson Cancer Research Center
Phone: 206-667-5077
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place