Project COMBAT: Combating Tobacco Use in the United States Army

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00948233
First received: July 16, 2009
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

The goal of this behavioral research study is to test a new multimedia anti-tobacco video game tailored to the U.S. Army. Researchers want to study how using the program affects tobacco use in soldiers, as compared to standard anti-tobacco programs.


Condition Intervention
Smoking
Smoking Cessation
Behavioral: Video Game
Behavioral: Pamphlet
Behavioral: Surveys

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Combating Tobacco Use in the United States Army

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Reductions in Smoking Initiation/Smokeless Tobacco Use and Smoking Cessation [ Time Frame: Baseline, immediately following completion of the program, and at 6- and 12-month follow-ups ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Saliva samples at the 12-month follow-up visit to measure level of cotinine, a chemical related to tobacco use.


Estimated Enrollment: 2050
Study Start Date: June 2009
Estimated Primary Completion Date: June 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Intervention
Educational video game
Behavioral: Video Game
Educational anti-tobacco video game played on arcade-type kiosk for three 30-minute sessions, plus CD-ROM disc of game to use as needed, and series of illustrated materials to go along with computer sessions.
Behavioral: Surveys
Computer surveys taken at 4 points throughout the study.
Other Name: Questionnaire
Standard Care
Pamphlets on stopping tobacco use
Behavioral: Pamphlet
Self-help pamphlet about stopping and avoiding tobacco use, provided by the National Institutes of Health.
Behavioral: Surveys
Computer surveys taken at 4 points throughout the study.
Other Name: Questionnaire

  Hide Detailed Description

Detailed Description:

Researchers in the M. D. Anderson Department of Behavioral Science are developing a new video game program for young U.S. Army service members. The game addresses stopping and preventing the use of cigarettes and smokeless tobacco. Soldiers (ages 18-35 years) stationed at Fort Hood, Texas, who are not scheduled to be mobilized for a 13-month period, will be invited to take part in the study.

The Study Groups:

If you choose to take part in this study, you will be assigned to a type of study intervention. The personnel companies on-base have been randomly assigned (as in the flip of a coin) to offer participating service members 1 of the following 2 programs: either the educational video game (called the "intervention"), or pamphlets on stopping tobacco use (called "standard care"). Each company will receive only 1 of the 2 programs, and all participating service members in the same company will receive the same program. Each company has an equal chance of being assigned to either program.

Intervention:

Participants in the intervention group will have a month to use the educational anti-tobacco video game located in areas that will provide convenient access. The game will be made available using an arcade-type kiosk which houses the computer game. After playing the video game on the kiosk for three 30-minute sessions, you will then be given a CD-ROM disc of the game to use as needed. After finishing these three 30-minute computer sessions, you will also receive a series of printed materials that go along with the computer sessions.

Standard Care:

The standard care participants will receive a self-help pamphlet about stopping and avoiding tobacco use, provided by the National Institutes of Health.

Both Intervention and Standard Care Groups:

No matter which group your company is assigned to, if you choose to take part, you will be asked to complete surveys by computer at 4 points throughout the study. The survey will include questions about tobacco use, such as how much tobacco you use, how many times you have tried to quit, how ready you are to quit, how dependent you are on nicotine, any withdrawal and breathing symptoms you experience, your level of alcohol use, and support from family and friends. Each survey should take about 30 minutes to complete.

The first surveys will take place at the start of study participation. The intervention group will complete the second survey right after finishing the program. The standard care group will complete this second survey at about the same time as the intervention group. Both groups will also complete the third and fourth surveys at 6- and 12-month follow-ups.

You will be asked to provide saliva samples at the 12-month follow-up visit. Researchers will use these saliva samples to measure the level of cotinine, a chemical in your saliva that is related to tobacco use. You will be asked to spit into a clean plastic container. A dipstick will be placed in the container for at least 30 minutes. After reading the dipstick and recording the result, the study staff will throw away the saliva sample right away.

You will also be told about the nicotine replacement therapy and other tobacco cessation services available at no cost through the Carl R. Darnall Army Medical Center (CRDAMC) Tobacco Cessation Program at Fort Hood. M. D. Anderson is collaborating with the CRDAMC Tobacco Cessation Program on this study.

This is an investigational study. Up to 2050 soldiers will be asked to take part in this study.

  Eligibility

Ages Eligible for Study:   18 Years to 35 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Soldiers (ages 18-35 years) stationed at Fort Hood, Texas, who are not scheduled to be mobilized for a 13-month period.

Criteria

Inclusion Criteria:

  1. Active duty service members, age 18 or above, who have entered the Army stationed at Fort Hood without orders for deployment or transfer within the next 13-month period
  2. Does not have to be a current smoker or user of alternative tobacco products
  3. Must provide contact information including: an address, two telephone numbers, and an AKO and alternate email address
  4. Willing to answer two questions regarding status of smoking and smokeless tobacco use on study survey
  5. Have access to the Internet
  6. Speak, read and write in English at a sixth-grade literacy level

Exclusion Criteria:

n/a

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00948233

Contacts
Contact: Alex Prokhorov, MD, PHD 713-745-2382

Locations
United States, Texas
Carl R. Darnall Army Medical Center (CRDMRC), Fort Hood Recruiting
Killeen, Texas, United States, 76544-4752
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Study Chair: Alex Prokhorov, MD, PHD UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT00948233     History of Changes
Other Study ID Numbers: 2009-0222, W81XWH-09-2-0033
Study First Received: July 16, 2009
Last Updated: March 31, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
Tobacco
Smoking Cessation
Prevention
Smokeless tobacco
Habit

Additional relevant MeSH terms:
Smoking
Tobacco Use Disorder
Habits
Substance-Related Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 16, 2014