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

Not Applicable

Completed

• Conditions: Cigarette Smoker; Current Every Day Smoker

• Registration Number: NCT00948129
• Lead Sponsor: M.D. Anderson Cancer Center

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.

Study Timeline

• Study First Submitted: 2009-07-14
• Study First Submitted QC: 2009-07-28
• Study First Posted: 2009-07-29
• Study Start: 2009-08-10
• Primary Completion: 2021-02-10
• Study Completion: 2021-02-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-18
• Last Update Posted: 2023-01-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 626

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Salivary cotinine levels	At 12 months	Salivary cotinine will be measured using the NicAlert test system.

Trial Locations

Locations (1)

M D Anderson Cancer Center; 🇺🇸 Houston, Texas, United States