Overview

This trial is active, not recruiting.

Conditions smoking cessation, habits, smoking
Treatments survey, counseling
Sponsor M.D. Anderson Cancer Center
Collaborator National Cancer Institute (NCI)
Start date June 2009
End date June 2017
Trial size 200 participants
Trial identifier NCT00941395, 2009-0351, 2R01CA069425-08A2

Summary

Objectives:

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification efficacy study
Intervention model single group assignment
Masking open label
Primary purpose treatment
Arm
(Experimental)
Smoking Cessation Intervention
survey Questionnaire
Completion of 3 surveys on the internet over the 3 months between the 1-week visit and the 3-month visit. The surveys should take about 20 minutes to complete.
counseling
Individual in-person study visits at 1 week, 3 months, and 6 months.
(Experimental)
Smoking Prevention Intervention
counseling
In-person end of study visit at 6 months.
survey Questionnaire
3 Internet-based surveys over 3 months, each taking approximately 20 minutes.

Primary Outcomes

Measure
Feasibility of smoking cessation program, using comparison of pre and post knowledge scores.
time frame: Baseline and 6 month post intervention

Eligibility Criteria

Male or female participants from 18 years up to 35 years old.

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

Additional Information

Official title Enhanced Smoking Cessation for University Students
Description Nonsmokers: Orientation: You will also attend a 1-hour orientation meeting about the study. The study staff will give a PowerPoint presentation that describes all study procedures and study participant responsibilities in detail. You will have a chance to ask the research staff questions at the meeting. Full Survey and Counselor Visit: Within about 2 weeks of the orientation meeting, you will be scheduled for a visit with a research study counselor. During the visit, you will complete a 30-minute survey on-line and then discuss the results with the counselor. The survey asks about health-related attitudes and behaviors such as your mood, sleep habits, alcohol and drug use, smoking and exercise habits. You will also have a saliva sample collected to check your smoking status. To collect a saliva sample, you will spit into a small plastic container. The entire visit should last about 1 hour. Email Messages: After the counselor visit, you will be emailed messages with information and links about the health risks of smoking, the environmental and financial impact of smoking, and the importance of healthy behaviors, such as stress and weight management. You will receive these messages every week for up to 3 months (up to 12 messages total). You will also receive up to 3 email reminders before your final follow up telephone call with the date and time of the call. Telephone Calls: At the end of the study (2 to 3 months after your first visit), you will receive a telephone call from research staff during which you will answer some of the survey questions from the first survey. You will also be asked questions about how you liked the website, how easy it was to use and how helpful it was to you. This call should last about 1 hour. You will receive an phone call reminder before your final follow-up telephone call with the date and time of the call. Length of Study: You may be on the study for up to 5 months. This is an investigational study. The use of this program to help prevent smoking is investigational. Up to 200 people will take part in this multicenter study. Up to 100 participants will take part in the "nonsmokers" part of this multicenter study. Up to 50 will be enrolled at the University of Houston Central Campus and up to 50 will be enrolled at Texas A&M University. Up to 50 smokers will also be enrolled at each campus. Smokers: Orientation: You will also attend a 1-hour orientation meeting about the study. The study staff will give a PowerPoint presentation that describes all study procedures and study participant responsibilities in detail. You will have a chance to ask the research staff questions at the meeting. Study Visit: You will have one in person study visit with a research study counselor. Within about 2 weeks of the orientation meeting, you will be scheduled for a visit with a research study counselor. During the visit, you will complete a 30-minute survey on-line and then discuss the results with the counselor. The survey asks about health-related attitudes and behaviors such as your mood, sleep habits, alcohol and drug use, smoking and exercise habits. This visit should take about 1 hour. You will also be asked to perform the following tests: - You will have a lung function test to learn how well your lungs work. To perform a lung function test, you will take a deep breath and blow into a mouthpiece that is connected to a device that records how much air your lungs can hold and shows how much force you use when breathing out. - Your carbon monoxide levels will be checked. You will breathe gently into a different machine that records how much carbon monoxide is in your lungs. - The study staff will discuss the results of the lung function test and the carbon monoxide test with you. - You will have a saliva sample collected to check your smoking status. To collect a saliva sample, you will spit into a small plastic container. - You will also have an interview about your tobacco use. You will be asked how much tobacco you use, about any time(s) you have tried to quit, how ready you are to quit, and how dependent you are on nicotine. You will also be asked about your overall mood and how often you use alcohol. - You will speak with a member of the study about how to quit smoking and your personal goals for quitting. - The study staff will give you instructions on how to get Nicorette Mini-Lozenges from the on-campus pharmacy. The on-campus pharmacy will provide detailed instruction on how to use the lozenges. - The study staff will also tell you about a website designed for this study. The website will have helpful tips and information on quitting smoking. A blog will also be available where you can post comments and start discussions. The study staff will teach you how to access and use the study website, blog and forum. Internet Surveys: In between the in-person study visit and the final follow up telephone call, you will be asked to complete up to 3 surveys on the Internet. The surveys will have questions based on your goals for quitting smoking, your responses from the tobacco use interview, and your answers from previous surveys. The surveys should take about 20 minutes to complete. After you complete the first Internet survey, you will receive a personalized newsletter on the study website based on the answers from your surveys, your lung tests, and the tobacco use interviews. You will be able to access and print the newsletter from the website. Email messages: You will receive an email to remind you to take your next on-line survey. You will also receive up to 3 email reminders before your final follow-up telephone call with the date and time of the call. Telephone Calls: At the end of the study (2 to 3 months after your first visit), you will receive a telephone call from research staff during which you will answer some of the survey questions from the first survey. You will also be asked questions about how you liked the website, how easy it was to use and how helpful it was to you. This call should last about 1 hour. You will receive an phone call reminder before your final follow up telephone call with the date and time of the call. Length of Study: You may be on study for up to 5 months. This is an investigational study. The use of this program to help quit smoking is investigational. Up to 200 people will take part in this multicenter study. Up to 100 participants will take part in the "smokers" part of this multicenter study. Up to 50 will be enrolled at the University of Houston Central Campus and up to 50 will be enrolled at Texas A&M University. Up to 50 nonsmokers will also be enrolled at each campus.
Trial information was received from ClinicalTrials.gov and was last updated in October 2015.
Information provided to ClinicalTrials.gov by M.D. Anderson Cancer Center.