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Study Summary
No. 2009-0336:.......Cancer Prevention......Alex Prokhorov......Behavioral Science
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Study Summary Title
Study Summary
Number:		2009-0336
Study Title:Project ACTION: Adult Smoking Cessation Treatment through Innovative Outreach to Neighborhoods
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Physician New Patient Referral
Name:Alex ProkhorovPatients Call:800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Dept:Behavioral ScienceReferring MD
Call:		800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)
Phone:713-745-2382
Contact us about clinical trials
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General Information
Disease Group:Cancer PreventionSupported By:NCI
Phase of Study:N/AReturn
Visit:		Never
Treatment
Agents:		NicotineHome Care:N/A
Treatment Loc:Only outside MDACC at one or more Collaborating Sites or Institutions
Estimated
Length of Stay
in Houston:		N/A
Description/
Intervention:		The goal of this study is to learn which of 3 methods is best for helping
people quit smoking.
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Study Objectives / Outcomes
Specific Aim 1: Specific Aim 1: Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial. The interventions will include a Standard Care (SC) approach, consisting of brief advice to quit smoking, nicotine replace therapy (NRT), and self-help written materials; an Enhanced Care (EC) approach, consisting of the standard care components and a cell phone-delivered text/graphical messaging component; and an Intensive Care (IC) approach, consisting of all SC and EC components plus a series of 11 cell phone-delivered proactive counseling sessions and a cell phone-delivered text/graphical messaging component.

    Hypothesis 1.1. Participants randomized to the EC condition will have higher smoking abstinence rates at 12-month follow-up compared to participants randomized to the SC condition.

    Hypothesis 1.2. Participants randomized to the IC condition will have higher smoking abstinence rates at 12-month follow-up compared to participants randomized to the EC condition.

Specific Aim 2: Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence

    Hypothesis 2.1: The EC's and IC's effects on abstinence will be mediated by quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect.
Specific Aim 3: Compare the cost-effectiveness of the three treatment conditions.
Hypothesis 3.1: Compared to SC and EC, the IC is a cost-effective use of health care resources.
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Study Status Information
Study Activation / Registration Date:08/10/2009
IRB Review and Approval Date:08/10/2009
Study Type:Behavioral
Recruitment Status:Open
Projected Accrual:756
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Enrollment Eligibility
If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.
Inclusion Criteria:1) Male or female, 18 years of age or older

2) Smoked at least 100 cigarettes in lifetime

3) English or Spanish speaking

4) Currently smoking at least 5 cigarettes a day, on average

5) Willing to set a quit smoking date within a week of the enrollment
Exclusion Criteria:1) Positive history of a medical condition that precludes use of the nicotine patch

2) Current use of nicotine replacement therapy (NRT)

3) Current use of other smoking cessation medications (e.g., Chantix or Zyban)

4) Pregnant or nursing

5) Enrolled in another smoking cessation study
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Links
Registration Number: NCT00948129
Study Information on Clinical Trials Registry (clinicaltrials.gov)
Other Links:
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Results

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