Trial Outcomes & Findings for Tobacco Treatment in the Context of Lung Cancer Screening (NCT NCT03927989)
NCT ID: NCT03927989
Last Updated: 2024-11-22
Results Overview
7-day point prevalence abstinence
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
48 participants
Primary outcome timeframe
Week 8 (end of treatment)
Results posted on
2024-11-22
Participant Flow
48 participants were consented in to the study, but 7 withdrew before randomization.
Participant milestones
| Measure |
Treatment Arm
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Text messaging plus nicotine replacement therapy: Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
|
Standard Care
Advice to quit and brief discussion of tobacco use
Standard Care at Lung Cancer Screening: Brief advice to quit smoking prior to lung cancer screening
|
|---|---|---|
|
Overall Study
STARTED
|
21
|
20
|
|
Overall Study
COMPLETED
|
21
|
19
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
| Measure |
Treatment Arm
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Text messaging plus nicotine replacement therapy: Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
|
Standard Care
Advice to quit and brief discussion of tobacco use
Standard Care at Lung Cancer Screening: Brief advice to quit smoking prior to lung cancer screening
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
Baseline Characteristics
Tobacco Treatment in the Context of Lung Cancer Screening
Baseline characteristics by cohort
| Measure |
Treatment Arm
n=21 Participants
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Text messaging plus nicotine replacement therapy: Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
|
Standard Care
n=19 Participants
Advice to quit and brief discussion of tobacco use
Standard Care at Lung Cancer Screening: Brief advice to quit smoking prior to lung cancer screening
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
21 Participants
n=35 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
19 Participants
n=35 Participants
|
|
Age, Continuous
|
65.4 years
STANDARD_DEVIATION 6.1 • n=39 Participants
|
63.4 years
STANDARD_DEVIATION 6.3 • n=41 Participants
|
64.4 years
STANDARD_DEVIATION 6.2 • n=35 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=39 Participants
|
10 Participants
n=41 Participants
|
22 Participants
n=35 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=39 Participants
|
9 Participants
n=41 Participants
|
18 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=39 Participants
|
19 Participants
n=41 Participants
|
40 Participants
n=35 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=39 Participants
|
8 Participants
n=41 Participants
|
13 Participants
n=35 Participants
|
|
Race (NIH/OMB)
White
|
15 Participants
n=39 Participants
|
11 Participants
n=41 Participants
|
26 Participants
n=35 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
1 Participants
n=35 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
|
Region of Enrollment
United States
|
21 participants
n=39 Participants
|
19 participants
n=41 Participants
|
40 participants
n=35 Participants
|
PRIMARY outcome
Timeframe: Week 8 (end of treatment)7-day point prevalence abstinence
Outcome measures
| Measure |
Treatment Arm
n=21 Participants
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Text messaging plus nicotine replacement therapy: Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
|
Standard Care
n=19 Participants
Advice to quit and brief discussion of tobacco use
Standard Care at Lung Cancer Screening: Brief advice to quit smoking prior to lung cancer screening
|
|---|---|---|
|
End of Treatment Abstinence Rates
|
3 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 3-month follow-upEffect size estimates at End of Study
Outcome measures
| Measure |
Treatment Arm
n=21 Participants
Advice to quit and brief discussion of tobacco use plus dual nicotine replacement therapy plus 8 weeks of gain-framed text messages tailored to lung cancer screening patients
Text messaging plus nicotine replacement therapy: Brief advice to quit smoking prior to lung cancer screening (LCS), 8 weeks of gain-framed, LCS-tailored text messages, and nicotine replacement therapy.
|
Standard Care
n=19 Participants
Advice to quit and brief discussion of tobacco use
Standard Care at Lung Cancer Screening: Brief advice to quit smoking prior to lung cancer screening
|
|---|---|---|
|
End of Study Abstinence Rates
|
1 Participants
|
0 Participants
|
Adverse Events
Treatment Arm
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Standard Care
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. Alana Rojewski (PI)
Medical University of South Carolina
Phone: 843-876-1593
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place