Smoking Cessation Intervention for Patients Undergoing Lung Surgery

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Massachusetts General Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00580398
First received: December 20, 2007
Last updated: September 18, 2009
Last verified: September 2009
  Purpose

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. Secondary aims are to assess smoking cessation rates just prior to surgical treatment and 3 months following surgery.


Condition Intervention Phase
Lung Cancer
Behavioral: CBT
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients

Resource links provided by NLM:


Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • Feasibility of recruitment and intervention completion. [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2008
Estimated Study Completion Date: December 2009
Estimated Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Behavioral: CBT
Combined CBT & pharmacotherapy

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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, and
  2. Had 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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00580398

Locations
United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Massachusetts General Hospital
Investigators
Principal Investigator: Elyse Park, Ph.D. MGH
  More Information

No publications provided

Responsible Party: Elyse R Park, MGH
ClinicalTrials.gov Identifier: NCT00580398     History of Changes
Other Study ID Numbers: 2007p-000838, 1 R03 CA130722-01
Study First Received: December 20, 2007
Last Updated: September 18, 2009
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 28, 2014