Smoking Cessation Intervention for Thoracic Patients
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| ClinicalTrials.gov Identifier: NCT00580398 |
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Recruitment Status :
Completed
First Posted : December 24, 2007
Results First Posted : November 21, 2014
Last Update Posted : October 12, 2018
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Sponsor:
Massachusetts General Hospital
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Elyse Park, PhD, Massachusetts General Hospital
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Lung Cancer | Behavioral: Smoking cessation counseling Drug: varenicline | Phase 1 Phase 2 |
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 (Clinical Trial) |
| Actual Enrollment : | 49 participants |
| Allocation: | Non-Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Pilot Smoking Cessation Study for Newly Diagnosed Lung Cancer Patients |
| Study Start Date : | January 2008 |
| Actual Primary Completion Date : | April 2012 |
| Actual Study Completion Date : | April 2012 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Lung cancer
| Arm | Intervention/treatment |
|---|---|
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No Intervention: Control
Usual care included physician advice to quit smoking.
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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.
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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 |
Primary Outcome Measures :
- 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 Outcome Measures :
- 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00580398
Locations
| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
Sponsors and Collaborators
Massachusetts General Hospital
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Elyse Park, Ph.D. | MGH |
Publications of Results:
| Responsible Party: | Elyse Park, PhD, Elyse Park, PhD, Principal Investigator, Massachusetts General Hospital |
| ClinicalTrials.gov Identifier: | NCT00580398 |
| Other Study ID Numbers: |
2007p-000838 1R03CA130722-01 ( U.S. NIH Grant/Contract ) |
| First Posted: | December 24, 2007 Key Record Dates |
| Results First Posted: | November 21, 2014 |
| Last Update Posted: | October 12, 2018 |
| Last Verified: | September 2018 |
Additional relevant MeSH terms:
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Lung Neoplasms Respiratory Tract Neoplasms Thoracic Neoplasms Neoplasms by Site Neoplasms Lung Diseases Respiratory Tract Diseases |
Varenicline Nicotinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs |