Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes

Study Overview
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Brief Summary
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Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling sessions and nicotine replacement therapy (NRT)) or 2) standard care + contingency management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers)

Detailed Description
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Participants will be recruited through the Thoracic Oncology Program and the Head and Neck Cancers Program. At the time of their initial surgical consultation, surgeons and their support staff in the Thoracic Oncology Program and Head and Neck Cancers Program will advise all of their patients about the present smoking cessation study as well as the Smoking Cessation Service at Smilow Cancer Hospital/Yale-New Haven Hospital and other resources in the community. Patients who express interest in the study and agree to quit smoking will be met at Smilow/YNHH for an intake appointment by a research assistant. Informed consent will be obtained prior to any other procedures, then during the intake session medical and tobacco use histories and breath carbon monoxide (CO) levels will be obtained from all participants. Study eligibility will be determined in concert with the surgeon and the principal investigator. As agreed upon by the surgeons, if participants meet eligibility criteria, their surgery will be scheduled for approximately 3 weeks after they enter the study. Eligible participants will be randomized to either: 1) standard care (i.e., 4 counseling sessions and NRT) or 2) standard care + contingency management (i.e., 4 counseling sessions and NRT + 3x/week meetings with positive reinforcers). After this, all subjects will be met by a study therapist for their first counseling session, which is a preparation to quit session. The study counseling protocol will be based on practical counseling, which is a cognitive behavioral evidence based smoking cessation treatment modality (Fiore, Jaén et al. 2008). All participants will be asked to set a quit date within a week after this session. Consistent with the standard practice of the Smoking Cessation Service, all patients will receive pharmacotherapy in conjunction with counseling.

Official Title
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Novel Treatments to Enhance Smoking Cessation Before Cancer Surgery: Effects on Smoking and Surgical Outcomes

Conditions
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Smoking Cessation

Intervention / Treatment
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* Other: standard care
* Other: standard care plus contingency management


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 or older, smoking 5 or more cigarettes per day, and diagnosed with any type of head, neck, or thoracic cancer, agreement on a 3-week pre-surgical tobacco intervention by both patient and surgeon. Exclusion Criteria: Unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia, history of allergic reactions to adhesives, females of childbearing potential who are pregnant, nursing, or not practicing effective contraception.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard care and nicotine replacement therapy<br>standard care is 4 counseling sessions and nicotine replacement therapy | Other: standard care<br>* standard care plus nicotine replacement therapy<br>|
| Experimental: standard care plus NRT plus contingency management<br>standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers | Other: standard care plus contingency management<br>* standard care is 4 counseling sessions and nicotine replacement therapy plus 3 weekly meetings with positive reinforcers<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| smoking cessation |  | up to 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, NRT nicotine replacement therapy, CBT cognitive behavioral therapy, contingency management