Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Cigarette Smoker
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 626
- Locations
- 1
- Primary Endpoint
- Smoking abstinence rate
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Smoking abstinence rate
Time Frame: At 12 months
The primary method of analysis will be mixed-model logistic regression.
Cost-effectiveness
Time Frame: 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 Outcomes
- Salivary cotinine levels(At 12 months)