A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients
Overview
- Phase
- Phase 1
- Intervention
- Smoking cessation counseling
- Conditions
- Lung Cancer
- Sponsor
- Massachusetts General Hospital
- Enrollment
- 49
- Locations
- 1
- Primary Endpoint
- Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Elyse Park, PhD
Elyse Park, PhD, Principal Investigator
Massachusetts General Hospital
Eligibility Criteria
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.
Arms & Interventions
Intervention
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: Smoking cessation counseling
Intervention
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
Outcomes
Primary Outcomes
Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention.
Time Frame: 12 weeks
Number of participants who completed the 12-week follow-up survey and thus the study.
Secondary Outcomes
- Biochemically-validated 7-day Point Prevalence Tobacco Abstinence(12 weeks)