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| ID | Type | Description | Link |
|---|---|---|---|
| 1R03CA130722-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | No Intervention | Usual care included physician advice to quit smoking. | |
| Intervention | Experimental | Intervention participants were provided with a cognitive-behavioral 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 offered 7 counseling sessions but were flexible in offering additional counseling when needed. Counseling was delivered by a certified Tobacco Treatment Counselor using Motivational Interviewing (MI) techniques. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Smoking cessation counseling | Behavioral | Median of 9 tobacco treatment counseling sessions conducted in person or by telephone. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 weeks |
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Inclusion Criteria:
A patient is eligible if he/she:
Exclusion Criteria:
Patients will be excluded from the intervention group if they are:
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| Name | Affiliation | Role |
|---|---|---|
| Elyse Park, Ph.D. | MGH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21512406 | Result | Park ER, Japuntich S, Temel J, Lanuti M, Pandiscio J, Hilgenberg J, Davies D, Dresler C, Rigotti NA. A smoking cessation intervention for thoracic surgery and oncology clinics: a pilot trial. J Thorac Oncol. 2011 Jun;6(6):1059-65. doi: 10.1097/JTO.0b013e318215a4dc. |
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Control | Usual care included physician advice to quit smoking. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Control | Usual care included physician advice to quit smoking. |
| BG001 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Number | participants | 12 weeks |
|
2 years (duration of study)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Control | Usual care included physician advice to quit smoking. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Psychiatric Instability | Psychiatric disorders | Non-systematic Assessment | Patient admitted for psychiatric evaluation for anxiety. At admission, patient was taking varenicline for 6 weeks per study protocol. Because varenicline can cause psychiatric side effects, event reported as possibly related to study medication. |
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The generalizability of the findings are limited by a single study site. The statistical power to detect differences was limited by the small sample size of this pilot study.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elyse Park, Ph.D., MPH | Massachusetts General Hospital | 617-724-6836 | epark@partners.org |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D000068580 | Varenicline |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D003376 | Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
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| varenicline | Drug | varenicline (1mg bid, with initial titration up over week 1) for 12 weeks |
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| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Units | Counts |
|---|
| Participants |
|
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| 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. | 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. | Posted | Number | participants | 12 weeks |
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|
| 0 |
| 17 |
| 0 |
| 17 |
| EG001 | 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. | 1 | 32 | 0 | 32 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D011810 | Quinoxalines |