An interventional study of Telephone Counseling and Telephone Assessments in Smoking, sponsored by M.D. Anderson Cancer Center. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by M.D. Anderson Cancer Center · Not applicable, Interventional, and Prevention
Objectives:
Participants for this study will be recruited mainly through media advertisements (such as TV, radio, newspapers, magazines, etc.).
If you are interested in participating in this study, you will be asked to provide demographic information, such as your name, telephone number, and address. You will then be mailed a packet, which will include a copy of this informed consent document, self-help reading materials, and a guide to answering the questionnaires.
Within about 2 weeks after you have received your packet, you will be interviewed by a research staff member by phone. You will be given detailed information about this study as part of the consent process. This is a telephone counseling study. Please read this copy of the consent very carefully. When the research staff member calls you in about 2 weeks, he or she will review this consent form with you. You should ask any questions you have about the consent or the study, and discuss any concerns you have with the research staff member. After discussing the consent and the study with the research staff member, you will be asked if you have read and understood the consent, and asked if you agree to participate in this study. Your consent to participate in this study will be tape recorded. This is so researchers can verify (know) that you have freely consented to participating in this study. You should keep this copy of the consent, and you may ask questions about it and/or the study at any time.
If you agree to participate, you will then go over several questionnaires with the interviewer. You may be asked questions about your living situation, mood, depression, anxiety, sleeping habits, appetite, smoking and alcohol use habits, social status, finances, job, physical activity, and support base (family and/or friends). Then a quit date will be set as well as the first telephone counseling call. This interview may take a total of about 1 hour to complete.
After this interview, participants will be randomly picked (as in the toss of a coin) to be in one of 2 groups. One group will receive standard quit-smoking counseling to help decrease their risk of cancer. The other group will also receive counseling, which will focus on decreasing the risk of getting cancer by decreasing smoking and alcohol use.
Your counselor will be contacting you to set up your first counseling call. You will receive a total of 7 counseling calls. You will discuss the timing of the counseling calls with your counselor based upon when it is felt to be most beneficial for you. 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 15 to 30 minutes each to complete.
At Weeks 12, 26 and 52, you will be interviewed by telephone by a research staff member, who will cover the same information as before. These evaluation (assessment) calls will take about 30 minutes each to complete. You will receive a total of 4 assessment phone calls. You will receive a total of 11 calls (including the counseling and assessment calls) over about a 12-month period of time.
Your counseling calls (not the assessment calls) will be tape recorded. You will be reminded before each counseling call that it will be taped recorded. This is 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.
Your participation in this study will be over after the assessment call at Week 52.
This is an investigational study. Up to 370 participant will take part in this multicenter study. None will be enrolled at M. D. Anderson.
925 studies on the registry are indexed under Alcohol Drinking; 172 are open to participants now.
This study's planned enrollment of 370 is above the median of 108 across 802 interventional studies indexed under Alcohol Drinking.
Browse Alcohol Drinking studies →M.D. Anderson Cancer Center is the lead sponsor of 2,999 studies on the registry; 581 are open to participants now.
Of its 599 completed or terminated interventional studies of FDA-regulated products, 402 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
MAPS+ (Motivation and Problem-Solving Plus): Counseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use.
Behavioral: Telephone Counseling · Behavioral: Telephone Assessments
MAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation.
Behavioral: Telephone Counseling · Behavioral: Telephone Assessments
7 counseling calls where quit date set on first counseling call; then counseling calls on quit date, 3-5 days after quit date, 7-10 days after quit date, 15-30 days after quit date, 45-60 days after quit date, and 90 days after quit date, each taking about 15 to 30 minutes to complete.
4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.
Also known as: Survey, Questionnaire
Continuous outcome variables (including number of drinks per day, self-efficacy, etc.)
Time frame: 2 Years
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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M.D. Anderson Cancer Center