Curbing Tobacco Use in Suburban and Rural Schools - Full Text View

Sponsors and Collaborators:	M.D. Anderson Cancer Center National Cancer Institute (NCI)
Information provided by:	M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:	NCT00513097

Purpose

Our primary, secondary, and tertiary specific aims are to answer the following questions about our interactive, Internet-based tobacco control intervention directed towards 10th-graders:

Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care?
Smoking Cessation (primary): Does the intervention result in higher rates of smoking cessation compared to standard care?
Reduction of Spit Tobacco Use (secondary): Does the intervention have an impact on spit tobacco use compared to standard care?
Stages of Change (tertiary): Does the intervention have an impact on progression through the stages of smoking and spit tobacco acquisition and cessation compared to standard care?
Mediating Variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation?
Testing Predictors:: Investigate established and recently elucidated predictors of susceptibility to smoking at baseline and 12-month follow-up.

Hypothesis 6.1. Higher self-efficacy, higher levels of exposure to smoking, pro-smoking attitudes, higher depressive symptoms, greater perception of peer use, greater risk-taking behavior, greater availability of tobacco, will be associated with higher levels of smoking susceptibility.
Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up Objective 7a. In an exploratory manner, a measure of smoking susceptibility of spit tobacco will be developed and tested
Testing Measures Across Race/Ethnicity: Explore predictors of susceptibility to smoking at baseline and 12-month follow-up to determine whether predictors differ among White, African-American, and Hispanic students.

Condition	Intervention	Phase
Epidemiology	Behavioral: Smoking Prevention Program Behavioral: Focus Group	Phase I

MedlinePlus related topics: Cancer Quitting Smoking Smokeless Tobacco Smoking Smoking and Youth

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Curbing Tobacco Use in Suburban and Rural Schools

Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:

To study the effectiveness of the Internet-based cigarette smoking and spit tobacco (ST) prevention and cessation in-class curriculum for rural teens. [ Time Frame: 3 Years ] [ Designated as safety issue: No ]

Estimated Enrollment:	2384
Study Start Date:	July 2006
Estimated Primary Completion Date:	July 2009 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Smoking Prevention Program	Behavioral: Smoking Prevention Program Interactive computer-based activities (like games) where asked questions about thoughts on smoking and tobacco. Behavioral: Focus Group A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.

Detailed Description:

Tenth-grade students will be asked to participate in tobacco prevention and cessation focus groups. Twenty focus groups will be conducted to test the following program fundamentals:

Group: Spit tobacco (ST) prevention
Groups: Smoking prevention
Groups: ST cessation
Groups: Smoking cessation
Groups: ST+smoking cessation x motivation & behavioral skills x 2 rural & suburban communities

In addition, 4 focus groups will be conducted to discuss and select the metaphor, animation styles, music, etc. Each group will include an equal mix of 5-8 male and 5-8 female participants and will be conducted immediately after school. A total of 24 focus groups will be held.

A trained facilitator and assistant moderator (recorder) will be used for each focus group. The facilitator will direct the discussion and keep the conversation flowing, and the recorder will take notes, operate the recording equipment, and maintain environmental conditions conducive to a coherent discussion. The facilitator and the moderator will debrief the participants and summarize the discussion at the conclusion of each focus group session. All focus groups and debriefing sessions will be tape-recorded for transcription. Each focus group will take about 40 minutes to complete.

Your child may refuse to participate (without any penalty) in any, or all, parts of this focus group if he or she chooses.

No identifying information (such as your child's name or contact information) will be collected. This is to make sure that your child's identity and his or her responses are kept confidential. Your child's data will not be shared with the school in any way that would allow your child to be identified. M. D. Anderson study staff will be present to monitor the entire intervention study and the completion of the follow-up surveys. At the end of this study, you may request a copy of the "Outcomes" paper that will be written and published about this study.

THIS IS AN INVESTIGATIONAL STUDY.

If you would like further information before deciding if you will allow your child to participate, you may contact Dr. Alexander Prokhorov, the Principal Investigator of this study, at (713) 745-2382 or (800) 472-4376.

Eligibility

Ages Eligible for Study:	14 Years to 16 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Subjects aged 14-16 years of age (10th-graders) who speak, read and write English
Subjects are students from schools located in suburban and rural communities approximately 200 miles from Houston.
Subjects with approved parental consent

Exclusion Criteria:

1) Disruptive individuals who are not able to work with the program

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513097

Contacts

Contact: Alex Prokhorov, MD, PhD

713-563-9529

Locations

United States, Texas
U.T.M.D. Anderson Cancer Center	Recruiting
Houston, Texas, United States, 77030
Principal Investigator: Alex Prokhorov, MD, PhD

Sponsors and Collaborators

M.D. Anderson Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Alex Prokhorov, MD, PhD

U.T.M.D. Anderson Cancer Center

More Information

The University of Texas M.D.Anderson Cancer Center This link exits the ClinicalTrials.gov site

Responsible Party:	U.T.M.D. Anderson Cancer Center ( Alex Prokhorov, MD, PhD/Professor )
Study ID Numbers:	2005-0914
Study First Received:	August 6, 2007
Last Updated:	December 22, 2008
ClinicalTrials.gov Identifier:	NCT00513097
Health Authority:	United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:

Epidemiology
Cancer Prevention
Smoking Cessation
Smoking Prevention
Focus Groups

Study placed in the following topic categories:

Smoking

ClinicalTrials.gov processed this record on January 15, 2009