Smoking Cessation Intervention for Thoracic Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Smoking cessation counseling
* Drug: varenicline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A patient is eligible if he/she: Is scheduled for a lung resection surgery with either a lung cancer diagnosis or a potential lung cancer diagnosis Smoked a cigarette in the past 2 weeks Is willing to make a pre-surgical quit attempt Exclusion Criteria: Patients will be excluded from the intervention group if they are: Non-English speaking Determined medically ineligible by their surgeon Suffering from psychosis or dementia Have been taking Varenicline for longer than three weeks Have been taking Bupropion (for smoking cessation purposes) for more than three weeks Is otherwise unable to participate in the intervention.
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Usual care included physician advice to quit smoking. | |
| Experimental: Intervention<br>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. | Behavioral: Smoking cessation counseling<br>* Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.<br>* Other names: Motivational Interviewing;Drug: varenicline<br>* varenicline (1mg bid, with initial titration up over week 1) for 12 weeks<br>* Other names: Chantix;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 |