Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening (LCS)

Study Overview
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Brief Summary
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This randomized controlled trial seeks to evaluate the effectiveness of alternative strategies to integrate smoking cessation interventions into the delivery of low-dose CT (LDCT) lung cancer screening. Using a factorial design, current smokers who enroll will be randomly assigned to receive these interventions: (1) smoking cessation counseling support by telephone or videoconferencing (short duration vs. long duration); (2) nicotine patch treatment (NRT) (short vs.long duration); (3) counselor-facilitated referral (vs. no referral) to an online resource to connect smokers to a community-based social service resources.

Detailed Description
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Evidence-based tobacco dependence treatment consists of behavioral counseling and pharmacotherapy. Nicotine patch is an FDA-approved cessation aid. The optimal duration of counseling and pharmacotherapy for patients undergoing low-dose CT (LDCT) lung screening is not clear. In addition, helping smokers to address other social and psychological barriers might help them succeed in quitting smoking. This randomized controlled trial will test, in a factorial design, two options for delivering each of 3 interventions to help current smokers stop smoking in the context of having routine CT lung cancer screening. Patients will receive 4 or 8 weeks of behavioral counseling (with their choice of video conferencing or regular telephone calls), 2 or 8 weeks of nicotine patch, and will receive referral (vs. no referral) to an online resource to connect smokers to community-based social service resources. Outcome measures for smoking cessation will be assessed by a survey administered by phone at 3,and 6 months.

Official Title
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Assessing the Integration of Tobacco Cessation Treatment Into Lung Cancer Screening

Conditions
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Smoking, Tobacco

Intervention / Treatment
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* Behavioral: Counseling
* Drug: Nicotine patch
* Behavioral: Community Resource


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Scheduled to undergo LDCT-LCS at a participating Mass General Brigham Health Care System LCS site Speak English or Spanish. Current smokers: smoked a cigarette, even a puff, in the last 30 days. Medicare coverage requirement (age 50-80 years, 20+ pack/years). Residing within the USA. Exclusion Criteria: Undergoing lung CT as part of a diagnostic or abnormal follow-up evaluation. Unable to give informed consent due to psychiatric or cognitive impairment as determined in consultation with study PI or treating clinician. No access to a telephone or cannot communicate by telephone.

Ages Eligible for Study
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Minimum Age: 50 Years
Maximum Age: 80 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: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Short, Short, Present<br>4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;Behavioral: Community Resource<br>* Counselor-facilitated referral to a community-based program to address social needs.<br>|
| Experimental: Short, Long, Present<br>4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;Behavioral: Community Resource<br>* Counselor-facilitated referral to a community-based program to address social needs.<br>|
| Experimental: Long, Short, Present<br>8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;Behavioral: Community Resource<br>* Counselor-facilitated referral to a community-based program to address social needs.<br>|
| Experimental: Long, Long, Present<br>8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;Behavioral: Community Resource<br>* Counselor-facilitated referral to a community-based program to address social needs.<br>|
| Experimental: Short, Short, Absent<br>4 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;|
| Experimental: Short, Long, Absent<br>4 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;|
| Experimental: Long, Short, Absent<br>8 weeks of counseling (by phone or videoconferencing) + 2 weeks of nicotine patch + no referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;|
| Experimental: Long, Long, Absent<br>8 weeks of counseling (by phone or videoconferencing) + 8 weeks of nicotine patch + no referral to community resource. | Behavioral: Counseling<br>* 4 or 8 weeks of behavioral counseling support to promote smoking cessation.<br>Drug: Nicotine patch<br>* 2 or 8 weeks of nicotine patch given in a tapering dose of 21 mg, 14 mg, 7 mg.<br>* Other names: NRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported past 7-day smoking abstinence | Patient self-report of no cigarette smoking in the past 7 days | 6 Months after enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self-reported past 7-day smoking abstinence | Patient self-report of no cigarettes smoked in the past 7 days | 3 months after enrollment | 
| Proportion of patients with >50% reduction in cigarettes smoked per day | >50% decrease in cigarettes smoked per day between baseline and follow-up | 3 Months | 
| Proportion of patients with >50% reduction in cigarettes smoked per day | >50% decrease in cigarettes smoked per day between baseline and follow-up | 6 months | 
| Proportion of patients who make an intentional attempt to quit smoking | Intentional attempt to quit smoking cigarettes that lasts for >=24 hours | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung screening