Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers

Study Overview
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Brief Summary
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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
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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.

Official Title
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Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods

Conditions
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Cigarette Smoker, Current Every Day Smoker

Intervention / Treatment
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* Other: Laboratory Biomarker Analysis
* Behavioral: Smoking Cessation Intervention
* Behavioral: Telephone-Based Intervention
* Other: Tobacco Cessation Counseling


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (standard care)<br>Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Behavioral: Smoking Cessation Intervention<br>* Undergo standard of care smoking cessation intervention<br>* Other names: Smoking and Tobacco Use Cessation Interventions;|
| Experimental: Group II (enhanced care)<br>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. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Behavioral: Smoking Cessation Intervention<br>* Undergo standard of care smoking cessation intervention<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Other: Tobacco Cessation Counseling<br>* Undergo smoking cessation counseling<br>|
| Experimental: Group III (intensive care)<br>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. | Other: Laboratory Biomarker Analysis<br>* Correlative studies<br>Behavioral: Smoking Cessation Intervention<br>* Undergo standard of care smoking cessation intervention<br>* Other names: Smoking and Tobacco Use Cessation Interventions;Behavioral: Telephone-Based Intervention<br>* Undergo telephone based smoking cessation intervention<br>Other: Tobacco Cessation Counseling<br>* Undergo smoking cessation counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Smoking abstinence rate | The primary method of analysis will be mixed-model logistic regression. | At 12 months | 
| Cost-effectiveness | 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. | At 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Salivary cotinine levels | Salivary cotinine will be measured using the NicAlert test system. | At 12 months |