Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Study Overview
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Brief Summary
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This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

Detailed Description
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PRIMARY OBJECTIVE: I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening. SECONDARY OBJECTIVES: I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare & Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit. II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study. OUTLINE: Participants are randomized to 1 of 2 groups. GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches. GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. After completion of study, participants are followed up at 1, 8, and 12 weeks.

Official Title
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Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial

Conditions
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Smoking, Lung Cancer

Intervention / Treatment
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* Other: Best Practice
* Drug: Nicotine Patch
* Other: Quality-of-Life Assessment
* Other: Questionnaire Administration
* Other: Tobacco Cessation Counseling


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: PATIENTS: Primary care patients PATIENTS: Upcoming primary care office visit PATIENTS: Current smoker PATIENTS: 30 plus (+) pack-year smoking history PATIENTS: English-speaking PROVIDERS: Primary health care providers PROVIDERS: Provide care to adults Exclusion Criteria: PATIENTS: History of lung cancer by self-report

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 77 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (centralized care strategy)<br>Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches. | Drug: Nicotine Patch<br>* Given nicotine patches<br>* Other names: Nicotine Transdermal Patch;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>Other: Tobacco Cessation Counseling<br>* Receive counseling over the phone<br>|
| Active Comparator: Group II (usual care)<br>Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit. | Other: Best Practice<br>* Receive usual care counseling<br>* Other names: standard therapy;Other: Quality-of-Life Assessment<br>* Ancillary studies<br>* Other names: Quality of Life Assessment;Other: Questionnaire Administration<br>* Ancillary studies<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence Questionnairre | Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates) | Up to 12 weeks | 
| Lung Cancer Screening 12 items version | Knowledge of lung cancer screening and benefits of smoking cessation | Up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who received smoking cessation counseling and shared decision making over the number of patients consented to participate in the study | Assessment of the reach of the intervention | Up to 12 weeks | 
| Acceptability, appropriateness, and feasibility of the intervention measure (Weiner et al). | Assessment of the feasibility of implementing the intervention | Up to 12 weeks | 
| Fidelity checklist (11 items) | Assessment of the feasibility of implementing the intervention | Up to 12 weeks | 
| EuroQoL-5 dimensions | Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.) | Up to 12 weeks | 
| Costs of implementing any smoking cessation plus shared decision making intervention | Costs of personnel, hardware, and delivering materials to participants | Up to 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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current smoker, health care provider, primary care doctor