CORE: CO Monitoring for Reach and Efficacy in Tobacco Treatment for Cancer Patients

Study Overview
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Brief Summary
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The purpose of this study is to assess the cessation success rates of an intensive tobacco treatment program in a patients undergoing cancer treatment at 30 days, 3 months and 6 months.

Detailed Description
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This mixed-methods, observational cohort study will assess intensive tobacco treatment with carbon monoxide monitoring offered to all eligible smoking patients presenting for cancer treatment to the NCCC at our main Lebanon campus and our very rural St. Johnsbury campus. Subjects will not be randomized and study will not be blinded. Cessation rates among the intensive tobacco treatment will be compared to usual care, matched historical controls, and to patients who refuse all tobacco treatment program elements.

Official Title
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CORE: CO Monitoring for Reach and Efficacy in Tobacco Treatment for Cancer Patients

Conditions
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Tobacco Use, Cancer

Intervention / Treatment
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* Behavioral: Intensive Tobacco Treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults age 18 and older Active Smoker at the time of initial consultation for cancer (defined as any smoking within 2 weeks of consult) Exclusion Criteria: Adults unable to consent Prisoners

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: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Usual Tobacco Treatment<br>All individuals who are identified as tobacco users are offered tobacco treatment which includes proactive, as needed, contacts via in person, telehealth or telephone visits. for tobacco treatment, pharmacotherapy as indicated, and Quitline and SmokefreeTXT referrals | |
| Experimental: Intensive Tobacco Treatment<br>Patients who consent to study participation will meet with a tobacco treatment specialist in-person initially, then biweekly via telephone or telehealth or face-to-face (or more frequently as needed). They will receive tobacco treatment counseling and support from certified tobacco treatment specialist, which may include pharmacotherapy as indicated. At enrollment, participants will undergo carbon monoxide testing using a carbon monoxide monitor. At baseline, participants will complete the Fagerström Test for Nicotine Dependence, and the Cancer Patient Tobacco Use Questionnaire (C-TUQ). These tobacco related survey measures will be completed at 3 additional time points: 30 days, 3 months and 6 months. | Behavioral: Intensive Tobacco Treatment<br>* Bi-weekly tobacco treatment counseling and regular carbon monoxide monitoring<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is smoking status | Change in smoking status (from smoking to not smoking) of those in an intensive tobacco treatment program at 30 days, 3 months and 6 months | 30 days, 3 Months, 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Motivational Impact of real-time carbon monoxide monitoring | Motivational impact of real-time carbon monoxide monitoring in patients receiving intensive tobacco treatment as determined by a Motivation to Quit Assessment Questionnaire | 6 Months | 
| Engagement Level with Tobacco Treatment via Telehealth | Level of engagement with tobacco treatment via telehealth compared to historical control face-to-face visits as determined by a Technology Access and Experiences Questionnaire | 6 Months |