Project HEALS (Helping and Empowering pAtients for Living a Life Smoke-free

Study Overview
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Brief Summary
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The purpose of the study is to pilot test a multi-modal smoking cessation and relapse prevention intervention with the lung cancer patient population and to obtain preliminary data on its feasibility.

Official Title
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Motivating Smoking Cessation and Relapse Prevention Among Lung Cancer Patients: Helping and Empowering pAtients for Living a Life Smoke-free (Project HEALS)

Conditions
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Smoking, Tobacco Use, Lung Cancer

Intervention / Treatment
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* Drug: Nicotine patch and lozenges
* Behavioral: Telephone counseling sessions
* Behavioral: Access to a web-based video
* Behavioral: Florida Tobacco Quitline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years of age or older Smoked at least 100 cigarettes in lifetime Current smoking (defined as self-report of any smoking, even a puff, in the past 30 days) Diagnosis of lung cancer Able to read and write English Not currently enrolled in a smoking cessation program Has a working telephone Has a valid home address Exclusion Criteria: Current use of tobacco cessation medications Another household member enrolled in this study Contraindication of nicotine patch, unless under the supervision of a physician as advised by project staff Moffitt clinical trial participant at time of enrollment

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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group 1: Usual Care<br>Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges). | Drug: Nicotine patch and lozenges<br>* Participants will receive nicotine patch and lozenges. The regimen will be based on the participant's self-reported smoking rate. At the time of enrollment, a research staff member will determine the proper dose. Participants who smoke >10 cigarettes/day will receive 8 weeks of 21 mg. patches, 2 weeks of 14 mg. patches, 2 weeks of 7 mg. patches, and 12 weeks of 2 mg. lozenges. Those who smoke <10 cigarettes/day will receive 8 weeks of 14 mg. patches, 4 weeks of 7 mg patches, and 12 weeks of 2 mg. lozenges<br>Behavioral: Florida Tobacco Quitline<br>* Participants will receive an offer of enrollment to the Florida Tobacco Quitline which enables participant to speak with a Quit Coach who will assess nicotine addiction and help create a quit plan.<br>|
| Experimental: Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention<br>Participants will receive brief advice to quit, an offer of enrollment to the Florida Tobacco Quitline, and a 12 week supply of nicotine replacement therapy (nicotine patches and lozenges), 6 telephone counseling sessions over 6 months, and access to a web based video. | Drug: Nicotine patch and lozenges<br>* Participants will receive nicotine patch and lozenges. The regimen will be based on the participant's self-reported smoking rate. At the time of enrollment, a research staff member will determine the proper dose. Participants who smoke >10 cigarettes/day will receive 8 weeks of 21 mg. patches, 2 weeks of 14 mg. patches, 2 weeks of 7 mg. patches, and 12 weeks of 2 mg. lozenges. Those who smoke <10 cigarettes/day will receive 8 weeks of 14 mg. patches, 4 weeks of 7 mg patches, and 12 weeks of 2 mg. lozenges<br>Behavioral: Telephone counseling sessions<br>* Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.<br>Behavioral: Access to a web-based video<br>* Participants will be given web-based access to the relapse prevention video Surviving Smokefree.<br>Behavioral: Florida Tobacco Quitline<br>* Participants will receive an offer of enrollment to the Florida Tobacco Quitline which enables participant to speak with a Quit Coach who will assess nicotine addiction and help create a quit plan.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants who meet inclusion criteria | Percentage of participants who meet inclusion criteria | Baseline | 
| Percentage of participants who agree to participate in the study | Percentage of participants who agree to participate in the study | Baseline | 
| Percentage of participants completing baseline assessment | Percentage of participants completing baseline assessment | Baseline | 
| Percentage of participants completing the 3 month follow-up assessments | Percentage of participants completing the 3 month follow-up assessments | at 3 months | 
| Percentage of participants completing the 6 month follow-up assessments | Percentage of participants completing the 6 month follow-up assessments | at 6 months | 
| Treatment satisfaction - Acceptability | Mean scores of the Client Satisfaction Questionnaire (SCQ-8) will be used for this measure. The CSQ-8 comprises 8 items for the assessment of treatment satisfaction using a scale from 8 to 32, with higher scores indicating greater satisfaction. | at 6 months | 
| Completion rate of MAPS calls for UC+MAPS+RP participants - Demand | Percentage of MAPS calls completed for UC+MAPS+RP participants | at 6 months | 
| Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand | Percentage of UC+MAPS+RP participants who viewed the web based video | at 3 months | 
| Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand | Percentage of UC+MAPS+RP participants who viewed the web based video | at 6 months |