Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting for Actively Smoking Family Members

Study Overview
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Brief Summary
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The purpose of this pilot study is to examine, in an innovative setting, the potential for a lung cancer diagnosis in a loved one to represent a teachable moment for smoking cessation in family members or caregivers who are current smokers. The researchers will identify the willingness and preferred modality for smoking cessation among family members/caregivers in this setting. The researchers will estimate abstinence rates at 4, 8, 12, and 24 weeks..

Official Title
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Beyond the Lung Cancer Diagnosis: Leveraging the Oncology Clinic Setting as a Potential Teachable Moment for Actively Smoking Family Members

Conditions
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Lung Cancer

Intervention / Treatment
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* Behavioral: Digital-based support
* Behavioral: Traditional-based support + Nicotine replacement therapy (NRT)


Participation Criteria
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Eligibility Criteria
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Patient Inclusion Criteria: patient with newly diagnosed lung cancer within the last 6 months of initial diagnosis/confirmation of diagnosis at the study sites Able to provide informed consent Able to speak and read English Family Member/Caregiver Participant Criteria: Family member or caregiver (defined as first degree relative [parent, sibling, child] or person living in the same household) Family member or caregiver must be a current, active smoker (defined as 10 cigarettes per day for 6 consecutive months). At least 18 years of age at time of study consent Able to provide informed consent Able to speak and read English Exclusion Criteria: Currently receiving formal tobacco dependence treatment- Nicotine replacement of any kind, varenicycline or Bupropion. Medical condition that precludes proposed pharmacotherapy for smoking cessation : Recent (≤ 2 weeks) myocardial infarction , history of underlying arrhythmias , history of serious or worsening angina pectoris, pregnancy and breastfeeding

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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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Digital-based support<br>Digital support will consist of referral for the participant to visit https://smokefree.gov, a website which offers a menu of internet- and text-based support options. | Behavioral: Digital-based support<br>* Digital support will consist of referral for the participant to visit https://smokefree.gov, a website which offers a menu of internet- and text-based support options.<br>|
| traditional-based support +nicotine replacement therapy(NRT)<br>Traditional support will consist of participant referral to the Indiana Tobacco Quitline (1-800-QUIT-NOW) which is a telephone hotline that connects participants to Indiana smoking cessation resources. | Behavioral: Traditional-based support + Nicotine replacement therapy (NRT)<br>* Traditional support will consist of participant referral to the Indiana Tobacco Quitline (1-800-QUIT-NOW) which is a telephone hotline that connects participants to Indiana smoking cessation resources.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 7-day point prevalence of self -reported smoking cessation |  | 4 weeks | 
| 7-day point prevalence of self -reported smoking cessation |  | 8 weeks | 
| 7-day point prevalence of self -reported smoking cessation |  | 12 weeks | 
| 7-day point prevalence of self -reported smoking cessation |  | 24 weeks | 
| Willingness to quit |  | 4 weeks | 
| Willingness to quit |  | 8 weeks | 
| Willingness to quit |  | 12 weeks | 
| Willingness to quit |  | 24 weeks | 
| Preference for type of cessation intervention modality | digital versus traditional support with nicotine replacement therapy [NRT] | 4 weeks | 
| Preference for type of cessation intervention modality | digital versus traditional support with nicotine replacement therapy [NRT] | 8 weeks | 
| Preference for type of cessation intervention modality | digital versus traditional support with nicotine replacement therapy [NRT] | 12 weeks | 
| Preference for type of cessation intervention modality | digital versus traditional support with nicotine replacement therapy [NRT] | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean change in readiness to quit | Measured via the Readiness to Quit Ladder | Baseline | 
| Mean change in readiness to quit | Measured via the Readiness to Quit Ladder | 4 weeks | 
| Mean change in readiness to quit | Measured via the Readiness to Quit Ladder | 8 weeks | 
| Mean change in readiness to quit | Measured via the Readiness to Quit Ladder | 12 weeks | 
| Mean change in readiness to quit | Measured via the Readiness to Quit Ladder | 24 weeks | 
| Mean change in nicotine dependence | Measured via the Heaviness of Smoking Index | Baseline | 
| Mean change in nicotine dependence | Measured via the Heaviness of Smoking Index | 4 weeks | 
| Mean change in nicotine dependence | Measured via the Heaviness of Smoking Index | 8 weeks | 
| Mean change in nicotine dependence | Measured via the Heaviness of Smoking Index | 12 weeks | 
| Mean change in nicotine dependence | Measured via the Heaviness of Smoking Index | 24 weeks | 
| Mean change in cigarette use | Measured by by the self-reported number of cigarettes smoked per day | Baseline | 
| Mean change in cigarette use | Measured by by the self-reported number of cigarettes smoked per day | 4 weeks | 
| Mean change in cigarette use | Measured by by the self-reported number of cigarettes smoked per day | 8 weeks | 
| Mean change in cigarette use | Measured by by the self-reported number of cigarettes smoked per day | 12 weeks | 
| Mean change in cigarette use | Measured by by the self-reported number of cigarettes smoked per day | 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung cancer, caregiver