Smoking Cessation Intervention for Thoracic Patients

Lung Cancer Clinical Trial

Official title:

A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00580398
• Other study ID #: 2007p-000838
• Secondary ID: 1R03CA130722-01
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 2008
• Est. completion date: April 2012

Study information

• Verified date: September 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: April 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms

Intervention

Behavioral:
• Smoking cessation counseling
Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.

Drug:
• varenicline
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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.0b013e3 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	12 weeks
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.	12 weeks