Smoking Cessation Intervention for Thoracic Patients

Mass General Brigham

Status and phase: Completed; Phase 2; Phase 1

Conditions: Lung Cancer

Treatments: Drug: varenicline; Behavioral: Smoking cessation counseling

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00580398

2007p-000838

1R03CA130722-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 49 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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49 participants in 2 patient groups

Control

No Intervention group

Description:

Usual care included physician advice to quit smoking.

Intervention

Experimental group

Description:

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.

Treatment:

Behavioral: Smoking cessation counseling

Drug: varenicline