- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00580398
Smoking Cessation Intervention for Thoracic Patients
September 13, 2018 updated by: Elyse Park, PhD, Massachusetts General Hospital
A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer 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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
49
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Massachusetts
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Boston, Massachusetts, United States, 02114
- Massachusetts General Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
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.
|
Median of 9 tobacco treatment counseling sessions conducted in person or by telephone.
Other Names:
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
12 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Elyse Park, Ph.D., MGH
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2008
Primary Completion (Actual)
April 1, 2012
Study Completion (Actual)
April 1, 2012
Study Registration Dates
First Submitted
December 20, 2007
First Submitted That Met QC Criteria
December 21, 2007
First Posted (Estimate)
December 24, 2007
Study Record Updates
Last Update Posted (Actual)
October 12, 2018
Last Update Submitted That Met QC Criteria
September 13, 2018
Last Verified
September 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Respiratory Tract Diseases
- Neoplasms
- Lung Diseases
- Neoplasms by Site
- Respiratory Tract Neoplasms
- Thoracic Neoplasms
- Lung Neoplasms
- Physiological Effects of Drugs
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Cholinergic Agents
- Nicotinic Agonists
- Cholinergic Agonists
- Varenicline
Other Study ID Numbers
- 2007p-000838
- 1R03CA130722-01 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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