Trial Outcomes & Findings for Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking (NCT NCT04409236)
NCT ID: NCT04409236
Last Updated: 2026-09-04
Results Overview
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.
ACTIVE_NOT_RECRUITING
NA
427 participants
At 12 months after randomization
2026-09-04
Participant Flow
Adult cancer patients who smoke were recruited nationally between 07/19/2021 and 06/03/2024 via social media ads, search engine results, and cancer clinics.
Participant milestones
| Measure |
Arm II (QuitGuide App)
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Arm I (Quit2Heal App)
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
|---|---|---|
|
3-Month Follow-up Survey
STARTED
|
213
|
214
|
|
3-Month Follow-up Survey
COMPLETED
|
163
|
169
|
|
3-Month Follow-up Survey
NOT COMPLETED
|
50
|
45
|
|
6-Month Follow-up Survey
STARTED
|
213
|
214
|
|
6-Month Follow-up Survey
COMPLETED
|
163
|
166
|
|
6-Month Follow-up Survey
NOT COMPLETED
|
50
|
48
|
|
12-Month Follow-up Survey
STARTED
|
213
|
214
|
|
12-Month Follow-up Survey
COMPLETED
|
158
|
155
|
|
12-Month Follow-up Survey
NOT COMPLETED
|
55
|
59
|
Reasons for withdrawal
| Measure |
Arm II (QuitGuide App)
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Arm I (Quit2Heal App)
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
|---|---|---|
|
3-Month Follow-up Survey
Lost to Follow-up
|
40
|
35
|
|
3-Month Follow-up Survey
Withdrawal by Subject
|
10
|
7
|
|
3-Month Follow-up Survey
Post-randomization exclusion for fraud
|
0
|
3
|
|
6-Month Follow-up Survey
Lost to Follow-up
|
39
|
35
|
|
6-Month Follow-up Survey
Withdrawal by Subject
|
11
|
10
|
|
6-Month Follow-up Survey
Post-randomization exclusion for fraud
|
0
|
3
|
|
12-Month Follow-up Survey
Lost to Follow-up
|
43
|
42
|
|
12-Month Follow-up Survey
Withdrawal by Subject
|
12
|
14
|
|
12-Month Follow-up Survey
Post-randomization exclusion for fraud
|
0
|
3
|
Baseline Characteristics
Quit2Heal Smartphone App in Helping Cancer Patients Quit Smoking
Baseline characteristics by cohort
| Measure |
Arm II (QuitGuide App)
n=213 Participants
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Arm I (Quit2Heal App)
n=211 Participants
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Total
n=424 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.0 Years
STANDARD_DEVIATION 11.0 • n=23 Participants
|
52.8 Years
STANDARD_DEVIATION 10.5 • n=23 Participants
|
52.4 Years
STANDARD_DEVIATION 10.8 • n=22 Participants
|
|
Sex/Gender, Customized
Sex · Female
|
176 Participants
n=23 Participants
|
165 Participants
n=23 Participants
|
341 Participants
n=22 Participants
|
|
Sex/Gender, Customized
Sex · Male
|
37 Participants
n=23 Participants
|
45 Participants
n=23 Participants
|
82 Participants
n=22 Participants
|
|
Sex/Gender, Customized
Sex · Unknown
|
0 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
1 Participants
n=22 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=23 Participants
|
3 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=23 Participants
|
1 Participants
n=23 Participants
|
4 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Black or African American
|
26 Participants
n=23 Participants
|
28 Participants
n=23 Participants
|
54 Participants
n=22 Participants
|
|
Race (NIH/OMB)
White
|
176 Participants
n=23 Participants
|
171 Participants
n=23 Participants
|
347 Participants
n=22 Participants
|
|
Race (NIH/OMB)
More than one race
|
7 Participants
n=23 Participants
|
6 Participants
n=23 Participants
|
13 Participants
n=22 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
2 Participants
n=23 Participants
|
2 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=23 Participants
|
7 Participants
n=23 Participants
|
16 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
204 Participants
n=23 Participants
|
204 Participants
n=23 Participants
|
408 Participants
n=22 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=23 Participants
|
0 Participants
n=23 Participants
|
0 Participants
n=22 Participants
|
|
Education Level
High school or less education
|
60 Participants
n=23 Participants
|
61 Participants
n=23 Participants
|
121 Participants
n=22 Participants
|
|
Education Level
Some college or more education
|
153 Participants
n=23 Participants
|
150 Participants
n=23 Participants
|
303 Participants
n=22 Participants
|
|
CESD-20 Depression Screen
CESD-20 score greater than or equal to 16
|
143 Participants
n=23 Participants
|
132 Participants
n=23 Participants
|
275 Participants
n=22 Participants
|
|
CESD-20 Depression Screen
CESD-20 score less than 16
|
70 Participants
n=23 Participants
|
79 Participants
n=23 Participants
|
149 Participants
n=22 Participants
|
|
Smoking Level
10 or fewer cigarettes per day
|
91 Participants
n=23 Participants
|
85 Participants
n=23 Participants
|
176 Participants
n=22 Participants
|
|
Smoking Level
11-20 cigarettes per day
|
97 Participants
n=23 Participants
|
100 Participants
n=23 Participants
|
197 Participants
n=22 Participants
|
|
Smoking Level
21 or more cigarettes per day
|
25 Participants
n=23 Participants
|
26 Participants
n=23 Participants
|
51 Participants
n=22 Participants
|
|
Cancer Stage
Stage 0, I, or II
|
95 Participants
n=23 Participants
|
103 Participants
n=23 Participants
|
198 Participants
n=22 Participants
|
|
Cancer Stage
Stage III or IV
|
66 Participants
n=23 Participants
|
74 Participants
n=23 Participants
|
140 Participants
n=22 Participants
|
|
Cancer Stage
Unknown
|
52 Participants
n=23 Participants
|
34 Participants
n=23 Participants
|
86 Participants
n=22 Participants
|
PRIMARY outcome
Timeframe: At 12 months after randomizationPopulation: Three participants were excluded post-randomization for fraud.
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.
Outcome measures
| Measure |
Arm II (QuitGuide App)
n=213 Participants
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Arm I (Quit2Heal App)
n=211 Participants
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
|---|---|---|
|
Number of Participants With 30-day Cigarette Smoking Cessation at 12 Months.
|
40 Participants
|
46 Participants
|
SECONDARY outcome
Timeframe: At 6 months after randomizationPopulation: Three participants were excluded post-randomization for fraud.
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.
Outcome measures
| Measure |
Arm II (QuitGuide App)
n=213 Participants
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Arm I (Quit2Heal App)
n=211 Participants
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
|---|---|---|
|
Number of Participants With 30-day Cigarette Smoking Cessation at 6 Months.
|
33 Participants
|
42 Participants
|
SECONDARY outcome
Timeframe: At 3 months after randomizationPopulation: Three participants were excluded post-randomization for fraud.
At 3 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.
Outcome measures
| Measure |
Arm II (QuitGuide App)
n=213 Participants
Patients receive the QuitGuide app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
Arm I (Quit2Heal App)
n=211 Participants
Patients receive the Quit2Heal app and are encouraged to use it frequently. During the entire 12-month follow-up period, the app will remain fully available anytime study participants wish to use it.
|
|---|---|---|
|
Number of Participants With 30-day Cigarette Smoking Cessation at 3 Months.
|
23 Participants
|
32 Participants
|
Adverse Events
Arm I (Quit2Heal App)
Arm II (QuitGuide App)
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place