Cigarette SmokerNCT00941395
Enhanced Smoking Cessation for University Students
A study testing Survey Administration in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center at 2 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Cigarette Smoker, Current Every Day Smoker
- What is being tested?
- Survey Administration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 Jun 2009to 8 Jun 2017
- Phase
- Interventional
- 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 18 to 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Show all 16Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Texas A&M
College Station, Texas, 77843
M D Anderson Cancer Center
Houston, Texas, 77030
About this study
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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.
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Being tested
- Survey Administration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete surveys
| Study group | Role | What they receive |
|---|---|---|
| Arm I (smoker, survey) | Experimental | 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. Receives: Other: Survey Administration |
| Arm II (non-smoker, survey) | Experimental | 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. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The ease of use and appeal of various features of the program
Measured: Up to 5 months
The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention
Measured: Up to 5 months
Behavior modification determined by EVOLVE Follow up Survey-Smoker
Measured: Up to 5 months
Knowledge of modules in the program
Measured: 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.
Measured: Up to 5 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2009 (estimated)
- Study start30 Jun 2009
- Primary completion8 Jun 2017
- Study completion8 Jun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cigarette SmokerStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 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
- Alexander Prokhorov, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00941395
- Sponsor's protocol ID
- 2009-0351
- Other IDs
- NCI-2018-02552, 2009-0351, P30CA016672, R01CA069425
- Status last verified
- Nov 2018
- First submitted
- 15 Jul 2009
- Last updated
- 21 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhanced Smoking Cessation for University Students
- ClinicalTrials.gov ID
- NCT00941395
- Acronym / sponsor ID
- 2009-0351
- Conditions
- Cigarette Smoker, Current Every Day Smoker
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 39 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 30 Jun 2009 (actual)
- Primary completion
- 8 Jun 2017 (actual)
- Study completion
- 8 Jun 2017 (actual)
- First posted
- 17 Jul 2009 (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.
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.
Detailed description
PRIMARY OBJECTIVES:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm I (smoker, survey) | Experimental | Other: Survey AdministrationParticipants 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 (non-smoker, survey) | Experimental | Other: Survey AdministrationParticipants 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. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- 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
Key exclusion criteria (8 listed)
- 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
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 |
|---|---|---|
| Survey AdministrationComplete surveys | Other | Arm I (smoker, survey), Arm II (non-smoker, survey) |
Primary outcome
The ease of use and appeal of various features of the program
Time frame: Up to 5 months
The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention
Time frame: Up to 5 months
Behavior modification determined by EVOLVE Follow up Survey-Smoker
Time frame: Up to 5 months
Knowledge of modules in the program
Time frame: 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
Time frame: Up to 5 months
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.
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 21 Nov 2018.
- 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.
Alexander Prokhorov principal investigator
M.D. Anderson Cancer Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Survey Administration in people with Cigarette Smoker and Current Every Day Smoker, run by M.D. Anderson Cancer Center at 2 sites 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 16 inclusion and 8 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 21 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
The ease of use and appeal of various features of the program (time frame: Up to 5 months). The study lists 5 primary outcomes in all. 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 21 Nov 2018.