Smoking Cessation Intervention for Thoracic Patients
|ClinicalTrials.gov Identifier: NCT00580398|
Recruitment Status : Completed
First Posted : December 24, 2007
Results First Posted : November 21, 2014
Last Update Posted : November 21, 2014
|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|
|Primary Completion Date :||April 2012|
|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 InterviewingDrug: varenicline
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.
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|