Lung Cancer
Conditions
Keywords
non-small cell lung cancer, small cell lung cancer
Brief summary
RATIONALE: Stop-smoking plans using a nicotine patch, in-person counseling, and computer-assisted counseling may help people stop smoking. PURPOSE: This randomized clinical trial is studying how well computer-assisted counseling helps African American smokers stop smoking.
Detailed description
OBJECTIVES: * Develop and evaluate the efficacy of an interactive, culturally sensitive, individualized, palmtop computer-delivered smoking cessation intervention for African American smokers. * Examine how hypothesized treatment mechanisms mediate the effects of computer-delivered treatment on abstinence. OUTLINE: This is a randomized study. A subset of 20 participants are assigned to arm II for pilot testing. All other participants are randomized to 1 of 2 intervention arms. * Arm I (standard care \[SC\]): Participants receive nicotine patch therapy on days -5 to 31. Participants also receive a Pathways to Freedom self-help guide and undergo 5 in-person counseling sessions based on the Treating Tobacco Use and Dependence Clinical Practice Guideline. The counseling sessions occur at 12 and 5 days prior to the quit smoking date and at 3, 10, and 31 days after the quit smoking date. * Arm II (computer-delivered treatment \[CDT\]): Participants receive the same intervention as in arm I. Participants also undergo CDT for 6 weeks comprising 5 modules (quitting strategies; motivation and support; general smoking information; calendars and fun stuff; and daily tips) beginning 12 days prior to the quit smoking date and continuing for 31 days after the quit smoking date. All participants complete questionnaires at baseline, during the counseling sessions, and then at approximately 6 months after the quit smoking date. After completion of study intervention, participants are followed at approximately 6 months. PROJECTED ACCRUAL: A total of 500 participants will be accrued for this study.
Interventions
BEHAVIORALSmoking cessation intervention
6 weeks of computer delivered treatment for quitting smoking
OTHERCounseling intervention
In-person counseling (5 sessions)
DRUGNicotine patch
6-week supply of the nicotine patch
Sponsors
National Cancer Institute (NCI)
M.D. Anderson Cancer Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. African American 2. Age 21 to 65 years 3. Current Smoker (history of at least 5 cigarettes/day for the last year) 4. Motivated to quit within the next 14 days 5. Participants must provide a viable home address and functioning home telephone number 6. Can speak, read, write in English at a sixth-grade literacy level 7. Provide viable collateral contact information 8. Register 8 or more on a carbon monoxide breath test
Exclusion criteria
1. Contraindication for nicotine patch use 2. Active substance dependence (exclusive of nicotine dependence) 3. Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless) 4. Use of bupropion or nicotine products other than nicotine patches supplied by the study 5. Pregnancy or lactation 6. Any active illness that precludes full participation in the study protocol 7. Another household member enrolled in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking status by SRNT Smoking Status Questionnaire 6 months after treatment | 6 months after treatment | Abstinence measures are collected at four post cessation follow-up visits. Point prevalence serving as the primary outcome measure. Primary outcome analyses will use data from all of the follow-up visits. SRNT Abstinence Status Questionnaire (Hughes et al., 2003) surveys the tobacco use by the participant and persons within the participant's household and social surroundings. The questionnaire also collects data on the use of other tobacco products and nicotine replacement medications. The pre- and post-quit versions of this questionnaire have been adapted to specific timepoints corresponding to participant visits. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Contemplating smoking by Contemplation Ladder 6 months after treatment | 6 months after treatment | The Contemplation Ladder (Biener & Abrams, 1991) assesses readiness to quit smoking and ranges from 0-10 with 0 being no thought of quitting and 10 being taking action to quit (e.g., cutting down, enrolling in a program). |
Countries
United States
Outcome results
None listed