Cigarette Smoker, Current Every Day Smoker
Conditions
Brief summary
This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.
Detailed description
PRIMARY OBJECTIVES: I. Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial. II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence. III. Compare the cost-effectiveness of the three treatment conditions. OUTLINE: Participants are randomized to 1 of 3 groups. GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials. GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks. GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks. After completion of study, participants are followed up at 3, 6, and 12 months.
Interventions
OTHERLaboratory Biomarker Analysis
Correlative studies
BEHAVIORALSmoking Cessation Intervention
Undergo standard of care smoking cessation intervention
BEHAVIORALTelephone-Based Intervention
Undergo telephone based smoking cessation intervention
Undergo smoking cessation counseling
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
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Smoked at least 100 cigarettes in lifetime * English or Spanish speaking * Currently smoking at least 5 cigarettes a day, on average * Willing to set a quit smoking date within a week of the enrollment
Exclusion criteria
* Positive history of a medical condition that precludes use of the nicotine patch * Current use of nicotine replacement therapy (NRT) * Current use of other smoking cessation medications (e.g., Chantix or Zyban) * Pregnant or nursing * Enrolled in another smoking cessation study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Smoking abstinence rate | At 12 months | The primary method of analysis will be mixed-model logistic regression. |
| Cost-effectiveness | At 12 months | Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Salivary cotinine levels | At 12 months | Salivary cotinine will be measured using the NicAlert test system. |
Countries
United States
Outcome results
None listed