NCT00941395

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
39

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2009

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 30, 2009

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

July 15, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 17, 2009

Completed
7.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 8, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 8, 2017

Completed
Last Updated

November 21, 2018

Status Verified

November 1, 2018

Enrollment Period

7.9 years

First QC Date

July 15, 2009

Last Update Submit

November 20, 2018

Conditions

Cigarette SmokerCurrent Every Day Smoker

Outcome Measures

Primary Outcomes (5)

  • The ease of use and appeal of various features of the program

    Up to 5 months

  • The quality of the interactive multi-media presentations and their ability to generate interest in smoking cessation and prevention

    Up to 5 months

  • Behavior modification determined by EVOLVE Follow up Survey-Smoker

    Up to 5 months

  • Knowledge of modules in the program

    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.

    Up to 5 months

Study Arms (2)

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.

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.

Other: Survey Administration

Interventions

Survey AdministrationOTHER

Complete surveys

Arm I (smoker, survey)Arm II (non-smoker, survey)

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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
  • 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
  • +1 more criteria

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Texas A&M

College Station, Texas, 77843, United States

Location

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

Study Officials

  • Alexander Prokhorov

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 15, 2009

First Posted

July 17, 2009

Study Start

June 30, 2009

Primary Completion

June 8, 2017

Study Completion

June 8, 2017

Last Updated

November 21, 2018

Record last verified: 2018-11

Locations

US(2)