Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

Study Overview
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Brief Summary
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This pragmatic trial will evaluate the value of routinely providing proactive smoking cessation support to current smokers as a part of participating in lung cancer screening within Veterans Health Administration.

Detailed Description
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This trial is a pragmatic randomized trial targeting the care of current smokers who are participating in lung cancer screening at two VA sites. Primary care providers at these sites will be randomized, and half will be offered tools to help integrate proactive smoking cessation support into the lung cancer screening process. Key proactive elements include proactive telephone outreach to all current smokers by a VA Quitline counselor that follows mailed results letters, and providing providers guidance in offering proactive cessation medication support as part of the lung cancer screening process.

Official Title
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Promoting Smoking Cessation in Lung Cancer Screening Through Proactive Treatment

Conditions
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Smoking Reduction, Tobacco Use, Tobacco Smoking, Tomography, Lung Diseases, Lung Neoplasms

Intervention / Treatment
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* Behavioral: Unsigned note to provider about cessation medication prescription
* Behavioral: Proactive Telephone Counseling from VA Quitline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Providers who schedule patients for a lung cancer screening at either of the two VA sites. Patients who participate in lung cancer screening and are current smokers at the time of scheduling their screening exam. Exclusion Criteria: Providers who currently systematically prescribe cessation support medication to all current smokers will be excluded. Patients with urgent findings requiring biopsy/immediate attention on the screening CT will be excluded. Patients with a prior diagnosis of lung cancer or who are receiving active therapy for any cancer, except skin cancer, will be excluded. Patients previously diagnosed with cognitive impairment, dementia, or severe behavioral disorders, or have an indication in chart review of difficulty communicating or participating in telephone counseling sessions will be excluded.

Ages Eligible for Study
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Maximum Age: 80 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Unstructured care<br>Providers in this arm will continue to provide care as usual during lung cancer screening, with no intervention from the study team. | |
| Experimental: Proactive care<br>Providers in this arm will receive guidance from the study team about offering lung cancer screening patients proactive cessation care, including cessation medications and behavioral telephone counseling. | Behavioral: Unsigned note to provider about cessation medication prescription<br>* For patients of providers assigned to the proactive study group, a local coordinator will review the patient's cessation medication history. If the patient is not currently being provided cessation support medication, the coordinator will enter a note and unsigned order for the provider about the recommended medication indicated by VA formulary guidelines.<br>Behavioral: Proactive Telephone Counseling from VA Quitline<br>* Patients of providers assigned to the proactive study group will be contacted by specially trained counselors at the VA Quitline. Counselors will attempt to provide two sessions of proactive telephone support.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported smoking abstinence | The primary outcome measure is self-reported abstinence from smoking 12 months after lung cancer screening, using information obtained from study surveys and electronic medical records | 12 months after lung cancer screening visit | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Providers' acceptance of proactive cessation care | Provider surveys will assess acceptance of and satisfaction with the proactive care approach among primary care clinicians referring Veterans for lung cancer screening | 0-12 weeks after provider offers patient lung cancer screening | 
| Cost of proactive cessation care | Costs of implementing the proactive care approach will be monitored and analyzed, including intervention staff effort, provider time, costs of telephone counseling, and pharmacotherapy costs | Through study completion | 
| Patients' experience with telephone counseling | Patient surveys will assess satisfaction with VA Quitline telephone counseling | 3 months after lung cancer screening visit | 
| Patients' motivational assessment | Surveys will assess patient motivation to quit smoking | 3 months after lung cancer screening visit | 
| Patients' perception of susceptibility to harm | Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective | 3 months after lung cancer screening visit | 
| Patients' self-efficacy assessment | Surveys will assess patients' self-efficacy for quitting smoking | 3 months after lung cancer screening visit | 
| Patients' motivational assessment | Surveys will assess patient motivation to quit smoking | 12 months after lung cancer screening visit | 
| Patients' perception of susceptibility to harm | Surveys will assess patients' perceived susceptibility to the harmful effects of smoking and perception of screening as protective | 12 months after lung cancer screening visit | 
| Patients' self-efficacy assessment | Surveys will assess patients' self-efficacy for quitting smoking | 12 months after lung cancer screening visit | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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smoking cessation, lung cancer screening, telephone counseling, quitline