Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment

Study Overview
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Brief Summary
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This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.

Detailed Description
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The overarching goal of this study is to test the impact of a precision risk feedback tool aiming to address gaps in clinician and patient uptake of lung cancer screening and tobacco treatment. This study builds on evidence that (1) clinical and genetic factors may inform precision risk on lung cancer and smoking cessation and (2) increasingly high demand for personal genetic risk in particular may signal its potential to activate behavior change. The multi-level precision prevention intervention to be tested--RiskProfile-- provides the opportunity to present personalized clinical and genetic information to increase clinician ordering and patient uptake of screening and treatment recommendations. This study aims to understand the relative benefit of a clinically-informed RiskProfile (based on clinical factors) over usual care, and the additional benefit of a genetically-informed RiskProfile (based on clinical and genetic factors) over the other intervention arms. Therefore, the investigators propose a 3-arm cluster randomized controlled trial of 90 clinicians and 825 screen-eligible patients from a diverse primary care setting (62% African American). Clinicians and patients will be randomized with 1:1:1 allocation to usual care vs. clinically-informed RiskProfile vs. genetically-informed RiskProfile to evaluate the effect of precision prevention interventions on screening and treatment. In Aim 1, the investigators will test the effect of RiskProfile on clinician orders for lung cancer screening and tobacco treatment. In Aim 2, the investigators will test the effect of RiskProfile on patient uptake of lung cancer screening and tobacco treatment. The investigators hypothesize that, compared to usual care, the outcomes of clinician ordering and patient receipt of screening and treatment will be higher in both RiskProfile groups and will be highest in the genetically-informed RiskProfile group. In Aim 3, the investigators will examine the effects of RiskProfile on potential mechanisms that may lead to increased uptake of lung cancer screening and tobacco treatment. The investigators hypothesize that RiskProfile will impact clinician perceptions about lung cancer screening and tobacco treatment that will, in turn, increase ordering behaviors. The investigators further hypothesize that these increases in clinician ordering, combined with changes in patient-level social-cognitive and engagement mechanisms, will increase lung cancer screening and tobacco treatment use among patients. The investigators will assess outcomes at enrollment (at the initial intervention visit), and at 3-month, 6-month, 12-month, and 18-month post-intervention follow-ups. Primary outcomes include clinician ordering and patient completion of lung cancer screening. Secondary outcomes include clinician prescribing and patient use of tobacco treatment, patient progress toward smoking cessation, and patient ongoing adherence to lung cancer screening. Mechanistic outcomes include patient social-cognitive and engagement factors, clinician perceptions about lung cancer screening and tobacco treatment, and clinician-patient interactions at the primary care visit. To better understand potential mechanistic influences of RiskProfile, the investigators will conduct qualitative semi-structured interviews with a subset of clinicians and patients, focused on decision-making processes as well as implementation barriers and facilitators for ordering and receiving lung cancer screening and tobacco treatment. At the nexus of primary care and lung cancer screening, this study will demonstrate the impact of this multi-level intervention designed to stimulate use of evidence-based and guideline-concordant care among primary care clinicians and racially-diverse, medically underserved patients at risk for lung cancer.

Official Title
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Precision Approaches to Lung Cancer Screening and Smoking Cessation Treatment in Primary Care

Conditions
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Smoking, Smoking Cessation, Tobacco Use Cessation

Intervention / Treatment
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* Behavioral: Usual Care
* Behavioral: RiskProfile-Clin
* Behavioral: RiskProfile-Gen


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: CLINICIANS: - Primary care clinician with active caseload in participating clinics PATIENTS: Patient of participating primary care clinician Lung cancer screening naïve Between 50 to 80 years of age, inclusive Currently smoking or quit within past 15 years Cumulative pack years ≥ 20 English-speaking Exclusion Criteria: PATIENTS: Lung cancer diagnosis Current order placed for lung cancer screening Unsuccessful DNA sample analyses

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clinicians will be randomized on a 1:1:1 basis to usual care, RiskProfile-Clin, or RiskProfile-Gen. Patients will be assigned to the same arm as their clinician.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual Care<br>Annual lung cancer screening with low-dose computed tomography (LDCT) is currently recommended in the U.S. for at-risk patients. Tobacco treatment and cessation is recommended for patients who smoke. | Behavioral: Usual Care<br>* Usual care incorporates guideline awareness and brief advice.<br>|
| Experimental: RiskProfile-Clin<br>RiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors. | Behavioral: RiskProfile-Clin<br>* RiskProfile-Clin incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors.<br>|
| Experimental: RiskProfile-Gen<br>RiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors. | Behavioral: RiskProfile-Gen<br>* RiskProfile-Gen incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors and genetic factors.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician ordering of lung cancer screening | This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening. | From enrollment through 6 months post-intervention | 
| Patient completion of lung cancer screening | This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening. | From enrollment through 6 months post-intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinician ordering of lung cancer screening | This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening. | From enrollment through 18 months post-intervention | 
| Patient completion of lung cancer screening | This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening. | From enrollment through 18 months post-intervention | 
| Patient completion of lung cancer screening, of those with order for screening | This will be quantified by the proportion of screen-eligible patients with an order for lung cancer screening who complete lung cancer screening. | From enrollment through 18 months post-intervention | 
| Patient ongoing adherence to annual repeat lung cancer screening | This will be quantified by the proportion of screen-eligible patients who complete a repeat annual lung cancer screening | From enrollment through 18 months post-intervention | 
| Clinician prescribing of tobacco treatment | This will be quantified by the proportion of screen-eligible current smokers who receive a clinician order for tobacco treatment (medication and/or counseling). | From enrollment through 18 months post-intervention | 
| Patient use of tobacco treatment | This will be quantified by the proportion of screen-eligible current smokers who use tobacco treatment (medication and/or counseling). | From enrollment through 18 months post-intervention | 
| Readiness to quit smoking | This will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action. | From baseline through 18 months post-intervention | 
| Smoking heaviness | This will be quantified by the average number of cigarettes smoked per day in the past 30 days. | From baseline through 18 months post-intervention | 
| Smoking abstinence | This will be quantified by a self-reported 7-day point prevalence. | From baseline through 18 months post-intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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precision prevention, genetically-informed interventions, lung cancer screening, tobacco treatment, risk feedback