Tobacco Use CessationPhase 1NCT00513097
Curbing Tobacco Use in Suburban and Rural Schools
A Phase 1 study testing Smoking Prevention Program, Focus Group and Survey in people with Tobacco Use Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Primary, secondary, and tertiary specific aims are to answer the following questions about interactive, Internet-based tobacco control intervention directed towards 10th-graders: 1. Smoking Prevention (primary): Does the intervention result in a lower incidence of smoking initiation compared to standard care? 2. Read more about this study
- Who is it for?
- Ages 14 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use Cessation
- What is being tested?
- Smoking Prevention Program, Focus Group and Survey
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,289 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jul 2006to 18 Oct 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Subjects aged 14-16 years of age (9th and 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
Who cannot join
- 1) Disruptive individuals who are not able to work with the program
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Primary, secondary, and tertiary specific aims are to answer the following questions about 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.
- Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up
- 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.
Read the detailed description
The proposed study will test the effectiveness of the Internet-based cigarette smoking and spit tobacco (ST) prevention and cessation in-class curriculum for rural teens. Supplemented by "cyber-support" (chat room and bulletin board), the intervention program also will make use of a human social support environment (via trained school personnel, chat rooms, bulletin boards). The study will use a nested cohort design in which high schools are the unit of design, allocation, and analysis. Tenth-grade students (ages 14-16) within each intervention school will receive a 7-week interactive, Internet-based tobacco prevention and cessation curriculum. Using computerized surveys, study participants will be evaluated at baseline, 6-month, 12-month, and 18-month follow-ups. The study has been designed to permit analyses sensitive enough to detect differences for the two primary hypotheses: reductions in smoking initiation and smoking cessation. Trends in ST use after exposure to the intervention program will also be assessed. The design will also permit analysis of stage-of-change dynamics and mediators for both acquisition and cessation of both forms of tobacco.
- Conditions
- Tobacco Use Cessation
- Being tested
- Smoking Prevention Program, Focus Group, Survey
- Keywords
- Epidemiology, Cancer Prevention, Smoking Cessation, Smoking Prevention, Focus Groups
- Medical subject headings
- Tobacco Use Cessation, Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Smoking Prevention ProgramBehavioural
Interactive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco.
Focus GroupBehavioural
A total of 24 focus groups will be held relating to the topics of smoking prevention and cessation.
SurveyBehavioural
On-line evaluations and questionnaires
| Study group | Role | What they receive |
|---|---|---|
| Smoking Prevention & Cessation Program | Experimental | Not described Receives: Behavioral: Smoking Prevention Program; Behavioral: Focus Group; Behavioral: Survey |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reductions in smoking initiation
Measured: Baseline, 6-month, 12-month, and 18-month
Secondary outcomes (1)
Smoking cessation
Measured: Baseline, 6-month, 12-month, and 18-month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Aug 2007 (estimated)
- Study start25 Jul 2006
- Primary completion18 Oct 2017
- Study completion18 Oct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco Use CessationStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 1,289 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alex Prokhorov, MD, PhD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00513097
- Sponsor's protocol ID
- 2005-0914
- Other IDs
- NCI-2011-02826, 2R01CA081934-05A1
- Status last verified
- Oct 2017
- First submitted
- 6 Aug 2007
- Last updated
- 6 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Curbing Tobacco Use in Suburban and Rural Schools
- ClinicalTrials.gov ID
- NCT00513097
- Acronym / sponsor ID
- 2005-0914
- Conditions
- Tobacco Use Cessation
- Keywords
- Epidemiology, Cancer Prevention, Smoking Cessation, Smoking Prevention, Focus Groups
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,289 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 25 Jul 2006 (actual)
- Primary completion
- 18 Oct 2017 (actual)
- Study completion
- 18 Oct 2017 (actual)
- First posted
- 8 Aug 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary, secondary, and tertiary specific aims are to answer the following questions about 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.
- Develop/Validate Spit Tobacco Measures: Investigate predictors of susceptibility of spit tobacco use at baseline and 12-month follow-up
- 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.
Detailed description
The proposed study will test the effectiveness of the Internet-based cigarette smoking and spit tobacco (ST) prevention and cessation in-class curriculum for rural teens. Supplemented by "cyber-support" (chat room and bulletin board), the intervention program also will make use of a human social support environment (via trained school personnel, chat rooms, bulletin boards). The study will use a nested cohort design in which high schools are the unit of design, allocation, and analysis. Tenth-grade students (ages 14-16) within each intervention school will receive a 7-week interactive, Internet-based tobacco prevention and cessation curriculum. Using computerized surveys, study participants will be evaluated at baseline, 6-month, 12-month, and 18-month follow-ups. The study has been designed to permit analyses sensitive enough to detect differences for the two primary hypotheses: reductions in smoking initiation and smoking cessation. Trends in ST use after exposure to the intervention program will also be assessed. The design will also permit analysis of stage-of-change dynamics and mediators for both acquisition and cessation of both forms of tobacco.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Smoking Prevention & Cessation Program | Experimental | Behavioral: Smoking Prevention Program, Behavioral: Focus Group, Behavioral: Survey |
Who may qualify
- Ages
- 14 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Subjects aged 14-16 years of age (9th and 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
Key exclusion criteria (1 listed)
- 1) Disruptive individuals who are not able to work with the program
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Smoking Prevention ProgramInteractive internet, computer-based activities (like games) with questions about thoughts on smoking and tobacco. | Behavioural | Smoking Prevention & Cessation Program |
| Focus GroupA total of 24 focus groups will be held relating to the topics of smoking prevention and cessation. | Behavioural | Smoking Prevention & Cessation Program |
| SurveyOn-line evaluations and questionnaires | Behavioural | Smoking Prevention & Cessation Program |
Primary outcome
Reductions in smoking initiation
Time frame: Baseline, 6-month, 12-month, and 18-month
1 secondary outcome
Smoking cessation
Time frame: Baseline, 6-month, 12-month, and 18-month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2017.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alex Prokhorov, MD, PhD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Smoking Prevention Program, Focus Group and Survey in people with Tobacco Use Cessation, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reductions in smoking initiation (time frame: Baseline, 6-month, 12-month, and 18-month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2017.