Smoking Cessation Intervention for Thoracic Patients

Phase 1

Completed

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.

Recruitment & Eligibility

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.

Arm && Interventions

Group	Intervention	Description
Intervention	Smoking cessation counseling	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.
Intervention	varenicline	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.