Trial Outcomes & Findings for Smoking Cessation Intervention for Thoracic Patients (NCT NCT00580398)
NCT ID: NCT00580398
Last Updated: 2018-10-12
Results Overview
Number of participants who completed the 12-week follow-up survey and thus the study.
COMPLETED
PHASE1/PHASE2
49 participants
12 weeks
2018-10-12
Participant Flow
This study used a non-randomized design, which began with a usual care control group enrollment period (January 2008-June 2008) that was followed by an intervention group (June 2008-August 2009)enrollment period. We recruited patients referred to thoracic surgery and oncology clinics at the Massachusetts General Hospital (MGH) in Boston, MA.
A patient had to be willing to take varenicline in order to be eligible for the intervention group; if a patient who was otherwise eligible for the intervention group was taking nicotine replacement therapy or bupropion, he/she had to be willing switch to varenicline.
Participant milestones
| Measure |
Control
Usual care included physician advice to quit smoking.
|
Intervention
Intervention participants were provided with a 12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling targeted to the issues of thoracic cancer patients. We had proposed to offer 7 counseling sessions but were flexible in offering additional sessions when needed. The counseling was delivered by a certified Tobacco Treatment Counselor using motivational interviewing (MI) techniques.
|
|---|---|---|
|
Overall Study
STARTED
|
17
|
32
|
|
Overall Study
COMPLETED
|
17
|
32
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Smoking Cessation Intervention for Thoracic Patients
Baseline characteristics by cohort
| Measure |
Control
n=17 Participants
Usual care included physician advice to quit smoking.
|
Intervention
n=32 Participants
12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
|
Total
n=49 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
58.0 years
STANDARD_DEVIATION 10.5 • n=5 Participants
|
57.5 years
STANDARD_DEVIATION 13.4 • n=7 Participants
|
57.7 years
STANDARD_DEVIATION 12.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
20 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
17 Participants
n=5 Participants
|
28 Participants
n=7 Participants
|
45 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksNumber of participants who completed the 12-week follow-up survey and thus the study.
Outcome measures
| Measure |
Control
n=17 Participants
Usual care included physician advice to quit smoking.
|
Intervention
n=32 Participants
12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
|
|---|---|---|
|
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
|
17 participants
|
32 participants
|
SECONDARY outcome
Timeframe: 12 weeksPopulation: 46 participants (32 intervention, 14 control) returned a cotinine confirmation kit for biochemical validation of 7 day point prevalent tobacco abstinence at 12 weeks. 3 control participants were excluded from the follow-up analysis.
7-day point prevalence abstinence ("Have you smoked a cigarette, even a puff, in the past 7 days?") was assessed at 12-week follow-up. Self reported abstinence was confirmed only if a salivary cotinine level was \< 15 ng/ml or an expired carbon monoxide measurement was \<10 ppm.
Outcome measures
| Measure |
Control
n=14 Participants
Usual care included physician advice to quit smoking.
|
Intervention
n=32 Participants
12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
|
|---|---|---|
|
Biochemically-validated 7-day Point Prevalence Tobacco Abstinence
|
2 participants
|
11 participants
|
Adverse Events
Control
Intervention
Serious adverse events
| Measure |
Control
n=17 participants at risk
Usual care included physician advice to quit smoking.
|
Intervention
n=32 participants at risk
12-week program consisting of varenicline (1mg bid, with initial titration up over week 1) and smoking cessation counseling sessions targeted to the issues of thoracic cancer patients.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Instability
|
0.00%
0/17 • 2 years (duration of study)
|
3.1%
1/32 • Number of events 1 • 2 years (duration of study)
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place