MDACC Study Summary 2009-0222

Study Summary
No. 2009-0222:.......Cancer Prevention......Alex Prokhorov......Behavioral Science

Study Summary Title



Study Summary Number:	2009-0222

Study Title:	Combating Tobacco Use in the United States Army

Physician

New Patient Referral



Name:	Alex Prokhorov	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-745-2382 Contact us about clinical trials

General Information



Disease Group:	Cancer Prevention	Supported By:	DoD

Phase of Study:	N/A	Return Visit:	Never

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only outside MDACC at one or more Collaborating Sites or Institutions

Estimated Length of Stay in Houston:	None


Description/ Intervention:	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.

Study Objectives / Outcomes

The primary, secondary, and tertiary specific aims of the proposed study are formulated to answer the following questions:

1. Smoking prevention (primary): Does the experimental intervention (an educational videogame with a series of printed materials) designed for active Army service members result in a lower incidence of smoking initiation compared to standard care?

2. Smoking cessation (primary): Does the experimental intervention result in higher rates of smoking cessation for active Army service members compared to standard care?

3. Reduction of smokeless tobacco (ST) use (secondary): Does the experimental intervention have an impact on ST use compared to standard care?

4. Stages of change (tertiary): Does the proposed experimental intervention have a positive impact on progression through the stages of smoking and ST acquisition and cessation?

5. Mediating variables (tertiary): How are mediating variables associated with tobacco-use onset and cessation?

6. Perception of experimental intervention vs. standard care (tertiary): How is the experimental intervention (educational videogame and accompanying printed materials) perceived by the users compared with the perception of the standard care pamphlet?

Study Status Information



Study Activation / Registration Date:	06/22/2009

IRB Review and Approval Date:	06/22/2009

Study Type:	Behavioral

Recruitment Status:	Open

Projected Accrual:	2050

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) Active duty service members 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 a viable e-mail address; have access to the internet; and speak, read, and write in English at a sixth-grade literacy level

4) Participants will be male and female, aged 18 to 35 years of age.

Exclusion Criteria:

1) Service members with close friends or family members enrolled in the current study. The justification for this exclusion is to prevent contamination of the intervention.

2) Service members participating in other studies and programs pertaining to tobacco use

3) Participation of individuals outside the targeted age range

Links

Registration Number: NCT00948233
Study Information on Clinical Trials Registry (clinicaltrials.gov)