MDACC Study Summary 2006-0468

Study Summary
No. 2006-0468:.......Cancer Prevention; Psychosocial......Carlos A. Mazas......Health Disparities Research

Study Summary Title



Study Summary Number:	2006-0468

Study Title:	Ecological Momentary Assessment of Smoking Cessation in Spanish-speaking Smokers

Physician

New Patient Referral



Name:	Carlos A. Mazas	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Health Disparities Research	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-5715 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention Psychosocial	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Participants must come to M. D. Anderson for a total of six visits: a screening and orientation visit, a visit one week prior to the quit date, a visit on the day they quit, and follow-up visits at 1, 2, and 4 weeks after the quit date.

Treatment Agents:	FTS Nicotine	Home Care:	All participants will receive Nicoderm Patch therapy for 4 weeks, self-help material, and counseling sessions.

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this behavioral research study is to look at psychosocial and behavioral factors that influence the process of quitting smoking among Spanish-speaking, Hispanic adult smokers.

Study Objectives / Outcomes

The specific aim of this project is to examine the mechanisms underlying the process of smoking cessation and relapse among Spanish-speaking Hispanic smokers, and to delineate how these mechanisms are influenced by education and acculturation
The primary aims of the study are to:

Specific Aim 1

Examine the intrapersonal and contextual determinants/antecedents (e.g., urges, affect, self-efficacy, sense of control, expectancies, stress, coping behavior, and social support) of daily experience, temptations to smoke, and smoking lapses among Spanish-speaking Hispanic smokers during a quit attempt.

Specific Aim 2

Examine the influence of education and acculturation on the antecedent events of smoking relapse.

NOTE A: This proposal is an extension of the parent grant, "Race/Ethnicity and the Process of Smoking Cessation" (PDOL# 2004-0786, Dr. David W. Wetter, PI). The parent grant is recruiting 150 African Americans, 150 Hispanic, and 150 Whites. The Hispanic smokers in the parent grant are English-speaking smokers. This proposal is recruiting Spanish-speaking Hispanic smokers.

NOTE B: To clarify for readers who are not familiar with the smoking cessation and relapse research a lapse or "slip" is typically defined as a single substance use episode that occurs after a person has successfully achieved a period of abstinence from the use of a particular substance. Lapses can easily transition to relapse, which is defined as a return to full-blown substance use.

Study Status Information



Study Activation / Registration Date:	08/21/2007

IRB Review and Approval Date:	08/21/2007

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	N/A

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) Age 21 to 65 years

2) Current smoker with a history of at least 5 cigarettes/day and/or a biochemical value of carbon monoxide (CO) of 10ppm

3) Motivated to quit within the next 15 days (preparation stage)

4) Home address and functioning home telephone number

5) Hispanics who can speak, read, write in Spanish at a marginal level according to The Test of Functional Health Literacy in Adults (STOFHLA)

Exclusion Criteria:

1) Contraindication for nicotine patch use

2) Current substance use and dependence according to the PHQ diagnostic criteria

3) Regular use of tobacco products other than cigarettes (cigars, pipes, smokeless)

4) Use of buproprion or nicotine replacement products other than the nicotine patches supplied by the study

5) Another household member enrolled in the study

6) Participation in a smoking cessation program or study during the past 90 days

Links

Registration Number: