Lung Cancer
Conditions
Brief summary
The primary aim of the proposed study is to develop and assess the feasibility of delivering a smoking cessation intervention to patients undergoing lung surgery that begins before surgery and continues up to 3 months post-discharge. The secondary aim is to assess smoking cessation rates 3 months following surgery.
Detailed description
This is a pilot study evaluating the feasibility of a cognitive-behavioral smoking cessation plus Varenicline program, designed specifically for early stage lung cancer patients and patients with a potential lung cancer diagnosis pre and post-surgery. The study population will be approximately 80 smokers who have upcoming lung resection surgery scheduled at Massachusetts General Hospital (MGH) in Boston. A patient will be considered eligible for the intervention or control group if he or she 1) is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis, and 2) had a cigarette in the past 2 weeks, 3) is willing to make a pre-surgical quit attempt. Patients will be excluded from the control group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon/oncologist, 3) suffering from psychosis or dementia 4) is currently on Varenicline has been on Varenicline for more than 3 weeks, or 5) is otherwise unable to participate in the intervention. Patients will be excluded from the intervention group if they are 1) non-English speaking, 2) determined medically ineligible by their surgeon, 3) suffering from psychosis or dementia 4) have been taking Varenicline for longer than three weeks 5) have been taking Bupropion (for smoking cessation purposes) for more than three weeks, 6) is otherwise unable to participate in the intervention.
Interventions
BEHAVIORALSmoking cessation counseling
Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
DRUGvarenicline
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
Sponsors
National Cancer Institute (NCI)
Massachusetts General Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
A patient is eligible if he/she: 1. Is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis 2. Smoked a cigarette in the past 2 weeks 3. Is willing to make a pre-surgical quit attempt
Exclusion criteria
Patients will be excluded from the intervention group if they are: 1. Non-English speaking 2. Determined medically ineligible by their surgeon 3. Suffering from psychosis or dementia 4. Have been taking Varenicline for longer than three weeks 5. Have been taking Bupropion (for smoking cessation purposes) for more than three weeks 6. Is otherwise unable to participate in the intervention.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention. | 12 weeks | Number of participants who completed the 12-week follow-up survey and thus the study. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biochemically-validated 7-day Point Prevalence Tobacco Abstinence | 12 weeks | 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. |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Control Usual care included physician advice to quit smoking. | 17 |
| Intervention 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. | 32 |
| Total | 49 |
Baseline characteristics
| Characteristic | Intervention | Total | Control |
|---|---|---|---|
| Age, Continuous | 57.5 years STANDARD_DEVIATION 13.4 | 57.7 years STANDARD_DEVIATION 12.4 | 58.0 years STANDARD_DEVIATION 10.5 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 2 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 31 Participants | 47 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) White | 28 Participants | 45 Participants | 17 Participants |
| Sex: Female, Male Female | 20 Participants | 29 Participants | 9 Participants |
| Sex: Female, Male Male | 12 Participants | 20 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 17 | 0 / 32 |
| serious Total, serious adverse events | 0 / 17 | 1 / 32 |
Outcome results
Primary
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
Number of participants who completed the 12-week follow-up survey and thus the study.
Time frame: 12 weeks
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention. | 17 participants |
| Intervention | Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention. | 32 participants |
Secondary
Biochemically-validated 7-day Point Prevalence Tobacco Abstinence
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.
Time frame: 12 weeks
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Biochemically-validated 7-day Point Prevalence Tobacco Abstinence | 2 participants |
| Intervention | Biochemically-validated 7-day Point Prevalence Tobacco Abstinence | 11 participants |