College Students and Smoking Cessation
This study is ongoing, but not recruiting participants.
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00941395
First received: July 15, 2009
Last updated: October 13, 2015
Last verified: October 2015
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Smoking Cessation Habits Smoking |
Behavioral: Survey Behavioral: Counseling |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Enhanced Smoking Cessation for University Students |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Feasibility of smoking cessation program, using comparison of pre and post knowledge scores. [ Time Frame: Baseline and 6 month post intervention ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2009 |
| Estimated Primary Completion Date: | June 2017 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Smokers
Smoking Cessation Intervention
|
Behavioral: Survey
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.
Other Name: Questionnaire
Behavioral: Counseling
Individual in-person study visits at 1 week, 3 months, and 6 months.
|
|
Experimental: Non-Smokers
Smoking Prevention Intervention
|
Behavioral: Counseling
In-person end of study visit at 6 months.
Behavioral: Survey
3 Internet-based surveys over 3 months, each taking approximately 20 minutes.
Other Name: Questionnaire
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 35 Years (Adult) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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: 18-35 years of age
- CESSATION ARM: Be enrolled in at least one class at respective campus at baseline
- CESSATION ARM: Provide current contact information
- 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: 18-35 years of age
- 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
Exclusion Criteria:
- 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
Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941395
Please refer to this study by its ClinicalTrials.gov identifier: NCT00941395
Locations
| United States, Texas | |
| Texas A&M University | |
| College Station, Texas, United States, 77843 | |
| University of Houston Central Campus | |
| Houston, Texas, United States, 77004 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Study Chair: | Alex Prokhorov, MD, PHD | M.D. Anderson Cancer Center |
More Information
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00941395 History of Changes |
| Other Study ID Numbers: | 2009-0351 2R01CA069425-08A2 |
| Study First Received: | July 15, 2009 |
| Last Updated: | October 13, 2015 |
| Health Authority: | United States: Institutional Review Board United States: Federal Government |
Keywords provided by M.D. Anderson Cancer Center:
|
Cancer Prevention College students Prevention intervention Smoking |
Tobacco Internet-based Cognitive Behavioral Therapy Nicotine lozenges |
ClinicalTrials.gov processed this record on September 26, 2016