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Trial of An Innovative Smartphone Intervention for Smoking Cessation

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ClinicalTrials.gov Identifier: NCT02724462
Recruitment Status : Completed
First Posted : March 31, 2016
Results First Posted : January 5, 2021
Last Update Posted : January 5, 2021
Sponsor:
Collaborators:
University of Washington
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Fred Hutchinson Cancer Research Center

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Investigator);   Primary Purpose: Treatment
Condition Smoking
Interventions Behavioral: Smartphone-delivered Intervention (SmartQuit)
Behavioral: : Smartphone-delivered Intervention (Standard of care app)
Enrollment 2503
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.
Pre-assignment Details  
Arm/Group Title Experimental Control
Hide Arm/Group Description Novel/experimental intervention smartphone smoking cessation app iCanQuit. Standard of care control smoking cessation app QuitGuide from NCI.
Period Title: 3 Month Follow-up Survey
Started 1254 1249
Completed 1043 1050
Not Completed 211 199
Reason Not Completed
Lost to Follow-up             171             151
Excluded as ineligible after randomization             40             48
Period Title: 6 Month Follow-up Survey
Started 1254 1249
Completed 1058 1078
Not Completed 196 171
Reason Not Completed
Lost to Follow-up             156             123
Excluded as ineligible after randomization             40             48
Period Title: 12 Month Follow-up Survey
Started 1254 1249
Completed 1040 1067
Not Completed 214 182
Reason Not Completed
Lost to Follow-up             174             134
Excluded as ineligible after randomization             40             48
Arm/Group Title Experimental Control Total
Hide Arm/Group Description Novel/experimental intervention smartphone smoking cessation app iCanQuit. Standard of care control smoking cessation app QuitGuide from NCI. Total of all reporting groups
Overall Number of Baseline Participants 1214 1201 2415
Hide Baseline Analysis Population Description
Participants not excluded as ineligible after randomization
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 1214 participants 1201 participants 2415 participants
38.2  (10.8) 38.3  (11.0) 38.2  (10.9)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1214 participants 1201 participants 2415 participants
Female
857
  70.6%
843
  70.2%
1700
  70.4%
Male
357
  29.4%
358
  29.8%
715
  29.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1214 participants 1201 participants 2415 participants
Hispanic or Latino
105
   8.6%
105
   8.7%
210
   8.7%
Not Hispanic or Latino
1109
  91.4%
1096
  91.3%
2205
  91.3%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1214 participants 1201 participants 2415 participants
American Indian or Alaska Native
28
   2.3%
30
   2.5%
58
   2.4%
Asian
5
   0.4%
1
   0.1%
6
   0.2%
Native Hawaiian or Other Pacific Islander
2
   0.2%
3
   0.2%
5
   0.2%
Black or African American
234
  19.3%
232
  19.3%
466
  19.3%
White
836
  68.9%
830
  69.1%
1666
  69.0%
More than one race
89
   7.3%
84
   7.0%
173
   7.2%
Unknown or Not Reported
20
   1.6%
21
   1.7%
41
   1.7%
Smoking level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1214 participants 1201 participants 2415 participants
21 or more cigarettes per day
249
  20.5%
239
  19.9%
488
  20.2%
20 or fewer cigarettes per day
965
  79.5%
962
  80.1%
1927
  79.8%
Education level  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1214 participants 1201 participants 2415 participants
High school or less education
500
  41.2%
495
  41.2%
995
  41.2%
Some college or more education
714
  58.8%
706
  58.8%
1420
  58.8%
CESD-20 Depression Screen   [1] [2] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 1208 participants 1197 participants 2405 participants
CESD-20 score greater than 15
583
  48.3%
583
  48.7%
1166
  48.5%
CESD-20 score less than or equal to 15
625
  51.7%
614
  51.3%
1239
  51.5%
[1]
Measure Description: Center for Epidemiological Studies Depression 20-item Scale (CESD-20). The range of possible CESD-20 scores is 0-60, with higher values indicating increased symptom severity.
[2]
Measure Analysis Population Description: Analysis population includes participants who sufficiently completed the CESD-20 items.
1.Primary Outcome
Title 30-day Point Prevalence Abstinence, Complete-case
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who reported 30-day point prevalence abstinence at 12 months post-treatment and who were not excluded as ineligible after randomization.
Arm/Group Title Experimental Control
Hide Arm/Group Description:
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
Standard of care control smoking cessation app QuitGuide from NCI.
Overall Number of Participants Analyzed 1040 1067
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
28.2
(25.5 to 31.0)
21.1
(18.7 to 23.7)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.49
Confidence Interval (2-Sided) 95%
1.22 to 1.83
Estimation Comments [Not Specified]
2.Secondary Outcome
Title 30-day Point Prevalence Abstinence, Missing=Smoking Imputation
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were not excluded as ineligible after randomization.
Arm/Group Title Experimental Control
Hide Arm/Group Description:
Novel/experimental intervention smartphone smoking cessation app iCanQuit.
Standard of care control smoking cessation app QuitGuide from NCI.
Overall Number of Participants Analyzed 1214 1201
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: Percentage of participants
24.1
(21.8 to 26.7)
18.7
(16.6 to 21.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Experimental, Control
Comments [Not Specified]
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .001
Comments [Not Specified]
Method Regression, Logistic
Comments [Not Specified]
Method of Estimation Estimation Parameter Odds Ratio (OR)
Estimated Value 1.40
Confidence Interval (2-Sided) 95%
1.14 to 1.71
Estimation Comments [Not Specified]
Time Frame Approximately 31 months, from the opening of the recruitment window to closure of the data collection window.
Adverse Event Reporting Description This is a smartphone-delivered behavioral intervention, so there were no known risks for serious adverse events, other adverse events, or all-cause mortality.
 
Arm/Group Title Experimental Control
Hide Arm/Group Description Novel/experimental intervention smartphone smoking cessation app iCanQuit. Standard of care control smoking cessation app QuitGuide from NCI.
All-Cause Mortality
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1214 (0.00%)   0/1201 (0.00%) 
Hide Serious Adverse Events
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1214 (0.00%)   0/1201 (0.00%) 
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Experimental Control
Affected / at Risk (%) Affected / at Risk (%)
Total   0/1214 (0.00%)   0/1201 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jonathan Bricker
Organization: Fred Hutchinson Cancer Research Center
Phone: 206-667-5077
EMail: jbricker@fredhutch.org
Layout table for additonal information
Responsible Party: Fred Hutchinson Cancer Research Center
ClinicalTrials.gov Identifier: NCT02724462    
Other Study ID Numbers: 8317
NCI-2018-02662 ( Registry Identifier: NCI / CTRP )
RG1001191 ( Other Identifier: Fred Hutch/University of Washington Cancer Consortium )
R01CA192849 ( U.S. NIH Grant/Contract )
First Submitted: March 24, 2016
First Posted: March 31, 2016
Results First Submitted: November 12, 2020
Results First Posted: January 5, 2021
Last Update Posted: January 5, 2021