Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

Study Overview
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Brief Summary
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The purpose of this clinical trial is to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery.

Detailed Description
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The investigators are proposing a developmental interdisciplinary pilot study to determine the feasibility and efficacy of an intervention designed to increase rates of tobacco abstinence for cancer patients before their cancer surgery. This study (a follow up to smaller pilot studies) will serve as a means to further develop a treatment protocol and to generate an accurate effect size for a full scale trial. The present study will constitute a development clinical trial with a primary aim of developing an effect size for smoking cessation at the time of surgery (7-day point prevalence abstinence), and a secondary aim of creating an effect size for long-term abstinence at 3 months post-surgery.

Official Title
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Novel Treatment to Enhance Smoking Cessation Before Cancer Surgery

Conditions
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Smoking Cessation

Intervention / Treatment
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* Behavioral: Contingency Management (CM)
* Behavioral: Standard of Care (SC)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 18 or older smoking ≥ 1 cigarettes per day CO > 6 ppm diagnosed with or suspicion of any type of operable thoracic, head and neck, breast, or gynecologic cancer agreement on a 2-5-week pre-surgical tobacco intervention by both patient and surgeon, and 6) residence within reasonable driving distance to New Haven. Exclusion Criteria: unstable psychiatric conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, or dementia unstable medical conditions that have not been well controlled (e.g., acute infection requiring hospitalization) for the past 30 days pregnant or breastfeeding women those with limited decision making capacity.

Ages Eligible for Study
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Minimum Age: 18 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Standard Care (SC)<br>Patients in the SC arm will receive 4 counseling sessions and nicotine patches as part of typical cessation measures delivered to patients. | Behavioral: Standard of Care (SC)<br>* Standard of care consists of smoking cessation counseling sessions and nicotine patches.<br>|
| Experimental: Contingency Management (CM)<br>Patients in the CM arm will receive monetary payment contingent on smoking abstinence (in addition to SC: 4 counseling sessions and nicotine patches). | Behavioral: Contingency Management (CM)<br>* CM is standard care plus monetary payment delivered contingent on abstinence.<br>Behavioral: Standard of Care (SC)<br>* Standard of care consists of smoking cessation counseling sessions and nicotine patches.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pre Surgery Smoking Abstinence | Participants will be classified as succeeded or failed in cessation based on a definition of 1 week of abstinence from cigarettes leading up to the day of their surgery based on self-report and confirmed with biochemical verification (CO≤6ppm). For participants who are classified as abstinent, a chi-square will be computed comparing whether treatment with CM is superior to SC in producing a higher probability of abstinence. These data will be used to compute an effect size, Cohen's w, for smoking cessation. | Day of Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post Surgery Smoking Abstinence | Participants will be classified 3 months post surgical procedure as succeeded or failed in cessation based on self-report and confirmed with biochemical verification (CO≤6ppm) in the 7 days prior to the 3-month follow-up. For participants who are classified as abstinent, a chi-square will be computed comparing whether treatment with CM is superior to SC in producing a higher probability of abstinence. | 3 months |