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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00592085 |
The specific aims are to:
Condition | Intervention |
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Smoking Cessation |
Behavioral: Questionnaires Behavioral: Motivational Relapse Prevention Counseling Behavioral: Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Open Label, Parallel Assignment, Efficacy Study |
Official Title: | Combined Treatment for Tobacco and Alcohol Use |
Estimated Enrollment: | 50 |
Study Start Date: | December 2007 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Active Comparator
Motivational Relapse Prevention Counseling
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Behavioral: Questionnaires
Participants will use a computer to complete a series of questionnaires.
Behavioral: Motivational Relapse Prevention Counseling
A total of 6 counseling calls during this study. Your first counseling call will be to set up your quit date. You will then have 5 additional counseling calls within the 12 weeks after your enrollment in the study. These calls will take about 20 to 30 minutes each to complete.
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2: Active Comparator
Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling
|
Behavioral: Questionnaires
Participants will use a computer to complete a series of questionnaires.
Behavioral: Motivational Relapse Prevention Plus Alcohol Risk Reduction Counseling
A total of 6 counseling calls during this study. Your first counseling call will be to set up your quit date. You will then have 5 additional counseling calls within the 12 weeks after your enrollment in the study. These calls will take about 20 to 30 minutes each to complete.
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Study Participation If you agree to take part in this study, you will come to M. D. Anderson and use a computer to complete a series of questionnaires. You will be asked questions about your living situation, mood, depression, anxiety, appetite, smoking and alcohol use habits, social status, finances, job, physical activity, and support from family and/or friends. These questionnaires may take a total of about 1 hour to complete.
After completing the questionnaires, you will be randomly assigned (as in the toss of a coin) to one of two groups. One group will receive counseling (called motivational relapse prevention counseling), which will focus on smoking cessation. The other group will also receive counseling (called motivational relapse prevention plus alcohol risk reduction counseling), which will focus on smoking cessation as well but will also include discussion about at-risk alcohol use. Both groups will receive reading materials related to smoking cessation. The motivational relapse prevention plus alcohol risk reduction group will also receive reading materials related to alcohol use.
You will receive a total of 6 counseling calls during this study. Your first counseling call will be to set up your quit date. You will then have 5 additional counseling calls within the 12 weeks after your enrollment in the study. The timing of these calls will be determined between you and your counselor. Depending on which group you are in, you will be counseled on strategies for quitting smoking and/or decreasing alcohol use to help decrease your risk of cancer. These calls will take about 20 to 30 minutes each to complete. You will be asked to provide contact information for friends and/or relatives. The research staff will contact them only if you are unable to be contacted after multiple attempts.
Final Visit At Week 12, you will be requested to return to M. D. Anderson to complete the last computerized series of questionnaires.
Your counseling calls will be tape recorded so researchers can make sure that correct procedures are being followed. Only the study staff will be allowed to listen to these tapes. Your identity will be kept secure and confidential. These tapes will be erased when this study has ended.
Study Length Your participation in this study will be over after the evaluation visit at Week 12.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: David Wetter, PHD, MS, BA | 713-745-2682 |
United States, Texas | |
U.T. M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: David Wetter, PHD, MS, BA |
Principal Investigator: | David Wetter, PHD, MS, BA | U.T. M.D. Anderson Cancer Center |
Responsible Party: | U.T. M.D. Anderson Cancer Center ( David Wetter, PHD, MS, BA /Professor ) |
Study ID Numbers: | 2007-0111 |
Study First Received: | December 27, 2007 |
Last Updated: | October 1, 2008 |
ClinicalTrials.gov Identifier: | NCT00592085 History of Changes |
Health Authority: | United States: Institutional Review Board |
Tobacco Use Smoking Alcohol Use Smoking Cessation |
Smoking Drinking Behavior Alcohol Drinking Ethanol |
Habits Smoking Drinking Behavior Alcohol Drinking |