Smoking Cessation Intervention for Thoracic Patients
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|ClinicalTrials.gov Identifier: NCT00580398|
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : November 21, 2014
Last Update Posted : October 12, 2018
|Condition or disease||Intervention/treatment||Phase|
|Lung Cancer||Behavioral: Smoking cessation counseling Drug: varenicline||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||49 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
No Intervention: Control
Usual care included physician advice to quit smoking.
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
varenicline (1mg bid, with initial titration up over week 1) for 12 weeks
Other Name: Chantix
- 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.
- 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.
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
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Elyse Park, Ph.D.||MGH|