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Project COMBAT: Combating Tobacco Use in the United States Army

2016年7月20日 更新者:M.D. Anderson Cancer Center

Combating Tobacco Use in the United States Army

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.

研究概览

详细说明

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.

研究类型

观察性的

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Soldiers stationed at Fort Hood, Texas, who are not scheduled to be mobilized for a 13-month period.

描述

Inclusion Criteria:

  1. Active duty service members, age 18 or above, who have entered the Army stationed at Joint Base San Antonio
  2. Does not have to be a current smoker or user of alternative tobacco products
  3. Must provide contact information including: an address, telephone number, and an 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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
干预/治疗
Intervention
Educational 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.
Computer surveys taken at 4 points throughout the study.
其他名称:
  • 调查问卷
Standard Care
Pamphlets on stopping tobacco use
Computer surveys taken at 4 points throughout the study.
其他名称:
  • 调查问卷
Self-help pamphlet about stopping and avoiding tobacco use, provided by the National Institutes of Health.

研究衡量的是什么?

主要结果指标

结果测量
大体时间
Reductions in Smoking Initiation/Smokeless Tobacco Use and Smoking Cessation
大体时间:Baseline, immediately following completion of the program, and at 6- and 12-month follow-ups
Baseline, immediately following completion of the program, and at 6- and 12-month follow-ups

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 学习椅:Alex Prokhorov, MD, PHD、M.D. Anderson Cancer Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始

2009年6月1日

初级完成 (实际的)

2016年7月1日

研究完成 (实际的)

2016年7月1日

研究注册日期

首次提交

2009年7月16日

首先提交符合 QC 标准的

2009年7月28日

首次发布 (估计)

2009年7月29日

研究记录更新

最后更新发布 (估计)

2016年7月21日

上次提交的符合 QC 标准的更新

2016年7月20日

最后验证

2016年7月1日

更多信息

与本研究相关的术语

其他研究编号

  • 2009-0222
  • W81XWH-09-2-0033 (其他标识符:DOD)

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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