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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-08-10

Study Completion Date

2021-02-10

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.

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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.

Conditions

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Cigarette Smoker Current Every Day Smoker

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Group I (standard care)

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

Group Type ACTIVE_COMPARATOR

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Undergo standard of care smoking cessation intervention

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 Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Undergo standard of care smoking cessation intervention

Tobacco Cessation Counseling

Intervention Type OTHER

Undergo smoking cessation counseling

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.

Group Type EXPERIMENTAL

Laboratory Biomarker Analysis

Intervention Type OTHER

Correlative studies

Smoking Cessation Intervention

Intervention Type BEHAVIORAL

Undergo standard of care smoking cessation intervention

Telephone-Based Intervention

Intervention Type BEHAVIORAL

Undergo telephone based smoking cessation intervention

Tobacco Cessation Counseling

Intervention Type OTHER

Undergo smoking cessation counseling

Interventions

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Laboratory Biomarker Analysis

Correlative studies

Intervention Type OTHER

Smoking Cessation Intervention

Undergo standard of care smoking cessation intervention

Intervention Type BEHAVIORAL

Telephone-Based Intervention

Undergo telephone based smoking cessation intervention

Intervention Type BEHAVIORAL

Tobacco Cessation Counseling

Undergo smoking cessation counseling

Intervention Type OTHER

Other Intervention Names

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Smoking and Tobacco Use Cessation Interventions

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes