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Smoking Cessation Intervention for Thoracic Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00580398
First received: December 20, 2007
Last updated: November 20, 2014
Last verified: November 2014
  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. The secondary aim is to assess smoking cessation rates 3 months following surgery.


Condition Intervention Phase
Lung Cancer
Behavioral: Smoking cessation counseling
Drug: varenicline
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel 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:
  • Determination of the Feasibility of a Cognitive Behavioral Smoking Cessation Intervention. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    Number of participants who completed the 12-week follow-up survey and thus the study.


Secondary Outcome Measures:
  • Biochemically-validated 7-day Point Prevalence Tobacco Abstinence [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 49
Study Start Date: January 2008
Study Completion Date: April 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Usual care included physician advice to quit smoking.
Experimental: 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.
Behavioral: Smoking cessation counseling
Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
Other Name: Motivational Interviewing
Drug: varenicline
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
Other Name: Chantix

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:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Publications:
Responsible Party: Elyse Park, PhD, Elyse Park, PhD, Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00580398     History of Changes
Other Study ID Numbers: 2007p-000838, 1 R03 CA130722-01
Study First Received: December 20, 2007
Results First Received: May 15, 2013
Last Updated: November 20, 2014
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Lung Neoplasms
Lung Diseases
Neoplasms
Neoplasms by Site
Respiratory Tract Diseases
Respiratory Tract Neoplasms
Thoracic Neoplasms
Varenicline
Cholinergic Agents
Cholinergic Agonists
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Nicotinic Agonists
Pharmacologic Actions
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on November 25, 2014