Enhanced Smoking Cessation for University Students

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.

Study Overview

• Status: Completed
• Conditions: Current Every Day Smoker; Cigarette Smoker
• Intervention / Treatment: Other: Survey Administration

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.

• Study Type: Interventional
• Enrollment (Actual): 39
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Texas
    • College Station, Texas, United States, 77843
      • Texas A&M
    • Houston, Texas, United States, 77030
      • M D Anderson Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm I (smoker, survey); 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.	Other: Survey Administration; Complete surveys
Experimental: Arm II (non-smoker, survey); 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.	Other: Survey Administration; Complete surveys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The ease of use and appeal of various features of the program		Up to 5 months
The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention		Up to 5 months
Behavior modification determined by EVOLVE Follow up Survey-Smoker		Up to 5 months
Knowledge of modules in the program		Up to 5 months
Feasibility defined as 90% of the student participants indicating that the intervention program is easy to use and can fit into their schedule	Associations between the dependent variables and smoking status will be evaluated with linear and logistic regression models with campus of origin and smoking status as independent predictors of these outcomes.	Up to 5 months

Collaborators and Investigators

• Sponsor: M.D. Anderson Cancer Center
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Alexander Prokhorov, M.D. Anderson Cancer Center

Publications and helpful links

Helpful Links

• MD Anderson Cancer Center Website

Study record dates

Study Major Dates

• Study Start (Actual): June 30, 2009
• Primary Completion (Actual): June 8, 2017
• Study Completion (Actual): June 8, 2017

Study Registration Dates

• First Submitted: July 15, 2009
• First Submitted That Met QC Criteria: July 15, 2009
• First Posted (Estimate): July 17, 2009

Study Record Updates

• Last Update Posted (Actual): November 21, 2018
• Last Update Submitted That Met QC Criteria: November 20, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 2009-0351 (Other Identifier: M D Anderson Cancer Center); P30CA016672 (U.S. NIH Grant/Contract); NCI-2018-02552 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); R01CA069425 (U.S. NIH Grant/Contract)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No