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

M.D. Anderson Cancer Center

Status: Completed

Conditions: Cigarette Smoker; Current Every Day Smoker

Treatments: Behavioral: Smoking Cessation Intervention; Other: Tobacco Cessation Counseling; Other: Laboratory Biomarker Analysis; Behavioral: Telephone-Based Intervention

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00948129

R01CA141628 (U.S. NIH Grant/Contract)

NCI-2018-00260 (Registry Identifier)

2009-0336 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 626 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

626 participants in 3 patient groups

Group I (standard care)

Active Comparator group

Description:

Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.

Treatment:

Other: Laboratory Biomarker Analysis

Behavioral: Smoking Cessation Intervention

Group II (enhanced care)

Experimental group

Description:

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.

Treatment:

Other: Laboratory Biomarker Analysis

Other: Tobacco Cessation Counseling

Behavioral: Smoking Cessation Intervention

Group III (intensive care)

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Based Intervention

Other: Laboratory Biomarker Analysis

Other: Tobacco Cessation Counseling

Behavioral: Smoking Cessation Intervention