MDACC Study Summary 2009-0351

Study Summary
No. 2009-0351:.......Cancer Prevention......Alex Prokhorov......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0351

Study Title:	Enhanced Smoking Cessation for University Students

Physician

New Patient Referral



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

Dept:	Behavioral Science	Referring 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

General Information



Disease Group:	Cancer Prevention	Supported By:	NCI

Phase of Study:	N/A	Return Visit:	Never

Treatment Agents:	Cognitive Behavioral Therapy Nicotine lozenges	Home 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 if nonsmokers between the ages of 18 and 35 are able to use a new website that is designed to prevent people from smoking. Researchers will also study how difficult or easy the program is to use.

Study Objectives / Outcomes

This study will help to establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression. In addition, we will demonstrate the feasibility of a smoking prevention website. Both cessation and prevention programs will be tailored to the needs of culturally diverse urban (University of Houston) and rural (Texas A&M) university campuses.

The specific aims are to investigate the following questions:

1. Feasibility: Is it feasible to implement a multi-faceted smoking cessation and prevention program comprising various intervention components in urban and rural college campuses?

Hypothesis 1.1:

At 6 months post-treatment,

students enrolled in the study will find the program appealing and report that it generates interest and effective use in urban and rural college campuses.

2. Smoking Cessation: Can an enhanced smoking cessation intervention that combines individual smoking cessation counseling, tailored Internet-based sessions, access to an Internet-based support site, and nicotine lozenges have an impact on smoking cessation in urban and rural college campuses?
Hypothesis 2.1: At 6 months post-treatment, student smokers enrolled in the study will benefit from our smoking cessation intervention (in terms of making quit attempts and quitting smoking).

3. Smoking Prevention: Can a smoking prevention intervention provided as a series of proactive e-mails with links to videos and interactive multimedia activities plus an interactive blog have an impact on smoking prevention in urban and rural college campuses?
Hypothesis 3.1: At 6 months after the end of treatment, nonsmokers exposed to our smoking prevention program will report an increase in resistance skills to pro-tobacco influences and maintaining tobacco-free lifestyle.

4. Mediating Variables: How are mediating variables associated with smoking cessation and initiation?
Hypothesis 4.1: Predictors of smoking cessation (e.g., level of depressive symptoms, alcohol use, nicotine dependence, perceived health status, self-efficacy, temptations to smoke, and pros and cons of smoking) will mediate the effect of the intervention on both prevention and cessation of smoking.

Hypothesis 4.2:

Predictors of smoking initiation (e.g., level of depressive symptoms, alcohol use, perceived health status, self-efficacy, temptations to smoke, and pros and cons of smoking) will mediate the effect of the intervention on smoking initiation.

5. Stages of Change: Does the proposed intervention have an impact on progression through the stages of smoking cessation and acquisition?

Hypothesis 5.1

Smokers' progression.

Students who are smokers at baseline will experience progression through the stages of change associated with smoking cessation.

Hypothesis 5.2. Nonsmokers' nonprogression. Students who are nonsmokers at baseline will progress through the stages of change associated with the acquisition of smoking.

Study Status Information



Study Activation / Registration Date:	06/30/2009

IRB Review and Approval Date:	06/30/2009

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	200

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) CESSATION ARM: Student at University of Houston Central Campus or Texas A&M University

2) CESSATION ARM: Smoke 1 or more cigarettes a day

3) CESSATION ARM: Speak and read English

4) CESSATION ARM: Signed Informed Consent and an acknowledgement of participation requirements

5) CESSATION ARM: 18-35 years of age

6) CESSATION ARM: Be enrolled in at least one class at respective campus at baseline

7) CESSATION ARM: Provide current contact information

8) CESSATION ARM: Have access to the Internet

9) PREVENTION ARM: Student at University of Houston Central Campus or Texas A&M University

10) PREVENTION ARM: Speak and read English

11) PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements

12) PREVENTION ARM: 18-35 years of age

13) PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline

14) PREVENTION ARM: Provide current contact information

15) PREVENTION ARM: Have access to the Internet

16) PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale)

17) CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

18) PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

Exclusion Criteria:

1) CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9])

2) CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT [Alcohol Use Disorders Identification Test] measure)

3) PREVENTION ARM: Current tobacco use

4) PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year

5) CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year

6) PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 [Patient Health Questionnaire-9])

7) PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)

8) CESSATION ARM: Pregnancy

Links

Registration Number: NCT00941395
Study Information on Clinical Trials Registry (clinicaltrials.gov)