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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1: Usual Care | Active Comparator | 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). |
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| Group 2: Usual Care + Motivation and Problem Solving + Relapse Prevention | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nicotine patch and lozenges | Drug | 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Vani N Simmons, PhD | Moffitt Cancer Center | Principal Investigator |
| Jennifer I Vidrine, PhD | Moffitt Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moffitt Cancer Center | Tampa | Florida | 33617 | United States |
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| ID | Term |
|---|---|
| D012907 | Smoking |
| D064424 | Tobacco Use |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D001519 | Behavior |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
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| ID | Term |
|---|---|
| D061485 | Tobacco Use Cessation Devices |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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| Telephone counseling sessions | Behavioral | Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period. |
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| Access to a web-based video | Behavioral | Participants will be given web-based access to the relapse prevention video "Surviving Smokefree". |
|
| Florida Tobacco Quitline | Behavioral | 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. |
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| 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 |
| D009369 |
| Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |