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Enhanced Smoking Cessation for University Students


N/A
18 Years
35 Years
Open (Enrolling)
Both
Smoking Cessation, Habits, Smoking

Thank you

Trial Information

Enhanced Smoking Cessation for University Students


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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of smoking cessation program, using comparison of pre and post knowledge scores.

Outcome Time Frame:

Baseline and 6 month post intervention

Safety Issue:

No

Principal Investigator

Alex Prokhorov, MD, PHD

Investigator Role:

Study Chair

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2009-0351

NCT ID:

NCT00941395

Start Date:

June 2009

Completion Date:

Related Keywords:

  • Smoking Cessation
  • Habits
  • Smoking
  • Cancer Prevention
  • College students
  • Prevention intervention
  • Smoking
  • Tobacco
  • Internet-based
  • Cognitive Behavioral Therapy
  • Nicotine lozenges
  • Smoking

Name

Location

Texas A&M UniversityCollege Station, Texas  77843
University of Houston Central CampusHouston, Texas  77004