Clinical trial NCT00941395: Enhanced Smoking Cessation for University Students
Official title: Enhanced Smoking Cessation for University Students
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cigarette Smoker
Current Every Day Smoker
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-07-17
Enrollment: 39
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This trial studies how well a new smoking cessation and prevention intervention works in enhancing smoking cessation for university students. The new intervention may be easier to use for students to quit smoke.

Detailed description: PRIMARY OBJECTIVES:

I. To establish the feasibility of a new smoking cessation and prevention intervention including two new modules addressing alcohol use and depression.

II. Demonstrate the feasibility of a smoking prevention website.

OUTLINE: Participants are assigned to 1 of 2 arms.

ARM I: Participants who currently smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2. Participants also complete 3 internet surveys over 20 minutes.

ARM II: Participants who currently do not smoke complete a survey over 30 minutes and discuss the survey results with the counselor over 30 minutes at week 2.

After completion of study, participants are followed up at 3 months.

Eligibility criteria: Inclusion Criteria:

* CESSATION ARM: Student at University of Houston Central Campus or Texas A\&M University
* CESSATION ARM: Smoke 1 or more cigarettes a day
* CESSATION ARM: Speak and read English
* CESSATION ARM: Signed informed consent and an acknowledgement of participation requirements
* CESSATION ARM: Be enrolled in at least one class at respective campus at baseline
* CESSATION ARM: Provide current contact information
* CESSATION ARM: Have access to the Internet
* PREVENTION ARM: Student at University of Houston Central Campus or Texas A\&M University
* PREVENTION ARM: Speak and read English
* PREVENTION ARM: Signed Informed Consent and an acknowledgement of participation requirements
* PREVENTION ARM: Be enrolled in at least one class at respective campus at baseline
* PREVENTION ARM: Provide current contact information
* PREVENTION ARM: Have access to the Internet
* PREVENTION ARM: Evidence of smoking susceptibility (as defined by the Smoking Susceptibility Scale)
* CESSATION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study
* PREVENTION ARM: Willing to answer all survey questions on all survey instruments throughout the duration of study

Exclusion Criteria:

* CESSATION ARM: Evidence of major depressive disorder (as defined by PHQ-9 \[Patient Health Questionnaire-9\])
* CESSATION ARM: Evidence of severe alcohol abuse (as defined by AUDIT \[Alcohol Use Disorders Identification Test\] measure)
* PREVENTION ARM: Current tobacco use
* PREVENTION ARM: Does not plan to continue as a student at their campus for at least one more year
* CESSATION ARM: Does not plan to continue as a student at their campus for at least one more year
* PREVENTION ARM: Evidence of major depressive disorder (as defined by PHQ-9 \[Patient Health Questionnaire-9\])
* PREVENTION ARM: Evidence of severe alcohol abuse (as defined by AUDIT measure)
* CESSATION ARM: Pregnancy

Primary outcomes:
measure: The ease of use and appeal of various features of the program
timeFrame: Up to 5 months
measure: The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention
timeFrame: Up to 5 months
measure: Behavior modification determined by EVOLVE Follow up Survey-Smoker
timeFrame: Up to 5 months
measure: Knowledge of modules in the program
timeFrame: Up to 5 months
measure: Feasibility defined as 90% of the student participants indicating that the intervention program is easy to use and can fit into their schedule
timeFrame: Up to 5 months
Secondary outcomes:
Other outcomes:
Locations:
city: College Station
country: United States
facility: Texas A&amp;M
state: Texas
city: Houston
country: United States
facility: M D Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Alexander Prokhorov
role: PRINCIPAL_INVESTIGATOR
References: