Implementation of a System-level Tobacco Treatment Intervention

Study Overview
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Brief Summary
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The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.

Detailed Description
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In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients. Adaption of CEASE will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process. Effectiveness of CEASE will be measured through questionnaires & biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (CEASE)

Official Title
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Implementation of a System-level Tobacco Treatment Intervention in Thoracic Oncology

Conditions
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Smoking Cessation, Lung Cancer

Intervention / Treatment
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* Other: CEASE
* Other: Usual Care Tobacco Treatment Services


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 Have an actual or potential diagnosis of thoracic malignancy Able to read and write in English. Current or recent former smoker (defined as having smoked within past 6 months) Must have an active telephone number. Exclusion Criteria: Former smoker greater than 6 months. Have any of the below conditions needing immediate medical intervention Hypercalcemia causing lethargy and confusion, Acute respiratory distress Dehydration Hypotension

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: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Cease-Aim 1<br>Cease Implementation 100 Patients after CEASE Implementation Exit Interview and Tobacco Use Survey | Other: CEASE<br>* Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE) CEASE is a system-level intervention that integrates tobacco-use screening, cessation assistance, and referral to outside services into routine visits<br>|
| Active Comparator: Pre Cease Implementation Aim 2<br>50 Current or former smokers (3 months +/-2 month) patients in usual care (before CEASE implementation) Tobacco Use Survey (Baseline,1- 6 Months) Biochemical verification | Other: Usual Care Tobacco Treatment Services<br> <br> |
| Experimental: After Cease Implementation Aim 2<br>50 Current or former smokers (3 months +/-2 month) Tobacco Use Survey (Baseline,1- 6 Months) Biochemical verification | Other: CEASE<br>* Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE) CEASE is a system-level intervention that integrates tobacco-use screening, cessation assistance, and referral to outside services into routine visits<br>|
| Active Comparator: Usual Care-Aim 1<br>Usual Care Tobacco Treatment Services 100 patients in usual care Exit Interview and Tobacco Use Survey | Other: Usual Care Tobacco Treatment Services<br> <br> |
| No Intervention: Clinician and Staff Survey<br>- Interview clinicians and support staff (40) | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking cessation Rate | Biochemical verification of smoking cessation | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Documentation of tobacco treatment | Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling) | 2 months after CEASE | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking Habits