Smoking, Tobacco Use, Lung Cancer
Conditions
Brief summary
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.
Interventions
DRUGNicotine patch and lozenges
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
BEHAVIORALTelephone counseling sessions
Participants will be offered 6 Motivation and Problem Solving (MAPS)-based counseling sessions by phone over a 6-month period.
BEHAVIORALAccess to a web-based video
Participants will be given web-based access to the relapse prevention video Surviving Smokefree.
BEHAVIORALFlorida Tobacco Quitline
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.
Sponsors
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of participants completing the 3 month follow-up assessments | at 3 months | Percentage of participants completing the 3 month follow-up assessments |
| Percentage of Participants who meet inclusion criteria | Baseline | Percentage of participants who meet inclusion criteria |
| Percentage of participants who agree to participate in the study | Baseline | Percentage of participants who agree to participate in the study |
| Percentage of participants completing baseline assessment | Baseline | Percentage of participants completing baseline assessment |
| Percentage of participants completing the 6 month follow-up assessments | at 6 months | Percentage of participants completing the 6 month follow-up assessments |
| Treatment satisfaction - Acceptability | at 6 months | 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. |
| Completion rate of MAPS calls for UC+MAPS+RP participants - Demand | at 6 months | Percentage of MAPS calls completed for UC+MAPS+RP participants |
| Percentage of UC+MAPS+RP participants who viewed the web-based video -Demand | at 3 months | Percentage of UC+MAPS+RP participants who viewed the web based video |
Countries
United States
Outcome results
None listed