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

Cigarette Smoker Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00948129
• Other study ID #: 2009-0336
• Secondary ID: NCI-2018-0026020
• Status: Completed
• Phase: N/A
• Start date: August 10, 2009
• Est. completion date: February 10, 2021

Study information

• Verified date: January 2023
• Source: M.D. Anderson Cancer Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 626
• Est. completion date: February 10, 2021
• Est. primary completion date: February 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cigarette Smoker
• Current Every Day Smoker

Intervention

Other:
• Laboratory Biomarker Analysis
Correlative studies

Behavioral:
• Smoking Cessation Intervention
Undergo standard of care smoking cessation intervention
• Telephone-Based Intervention
Undergo telephone based smoking cessation intervention

Other:
• Tobacco Cessation Counseling
Undergo smoking cessation counseling

Locations

Country	Name	City	State
United States	M D Anderson Cancer Center	Houston	Texas

Sponsors (2)

Lead Sponsor	Collaborator
M.D. Anderson Cancer Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking abstinence rate	The primary method of analysis will be mixed-model logistic regression.	At 12 months
Primary	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	Salivary cotinine levels	Salivary cotinine will be measured using the NicAlert test system.	At 12 months