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Completed

NCT Number: NCT00580398

Smoking Cessation Intervention for Thoracic Patients

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.

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Key information

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Smoking Cessation Counseling

Behavioral

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

Other names: Motivational Interviewing

Varenicline

Drug

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

Other names: Chantix

Primary outcomes

  1. 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

  1. Biochemically-validated 7-day Point Prevalence Tobacco Abstinence

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients

Important dates

Study start
2008
Primary completion
2012
Study completion
2012
First posted
Dec 24, 2007
Registry last updated
Oct 12, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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