Smoking Cessation Intervention for Thoracic Patients

NCT ID: NCT00580398

Last Updated: 2018-10-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2012-04-30

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control

Usual care included physician advice to quit smoking.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Smoking cessation counseling

Intervention Type: BEHAVIORAL

Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.

varenicline

Intervention Type: DRUG

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

Interventions

Smoking cessation counseling

Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.

Intervention Type: BEHAVIORAL

varenicline

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

Intervention Type: DRUG

Other Intervention Names

Motivational Interviewing; Chantix

Eligibility Criteria

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.

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Elyse Park, PhD

Elyse Park, PhD, Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elyse Park, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

MGH

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

References

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.0b013e318215a4dc.

Reference Type: RESULT

PMID: 21512406 (View on PubMed)

Other Identifiers

1R03CA130722-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2007p-000838

Identifier Type: -

Identifier Source: org_study_id