SmokingNCT00570804
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico
A study testing Telephone Counseling and Telephone Assessments in people with Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
Objectives: 1. Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation. 2. Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy, decreased temptations/craving, decreased stress and negative affect) and the role of those mechanisms in mediating MAPS and MAPS+ effects… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking
- What is being tested?
- Telephone Counseling and Telephone Assessments
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2007to 22 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Current (daily) smoker requesting help for smoking cessation
- Exhibit at least one of the following criteria for at-risk drinking: a) an average of =/> 2 alcoholic beverages/day during the past 30 days for men or =/>1 drink/day for women, OR b) two or more occasions of consuming /=> 5 alcoholic beverages during the past 30 days for men or =/>4 drinks for women, OR c) in the past 30 days, driving after consuming =/>3 drinks.
- Age 18 or above
- Motivated to quit smoking in the next 30 days
- Viable (working) telephone number and home address
- No other household member enrolled in this protocol
- Residing in Puerto Rico
- Must score less than or equal to 15 on the AUDIT (Alcohol Use Disorders Identification Test)
Who cannot join
- Currently incarcerated or in jail
- Currently pregnant
- Score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT) measure.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
Objectives:
- Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
- Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy, decreased temptations/craving, decreased stress and negative affect) and the role of those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
- Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
Read the detailed description
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.
- Conditions
- Smoking
- Being tested
- Telephone Counseling, Telephone Assessments
- Keywords
- Smoking Cessation, Puerto Rico Quitline, Motivational Relapse Prevention, Oral Cancer, Risk Reduction, Tobacco Use, Alcohol Use, MAPS, Motivation and Problem-Solving, Telephone Interview, Counseling
- Medical subject headings
- Smoking, Smoking Cessation, Mouth Neoplasms, Risk Reduction Behavior, Tobacco Use, Alcohol Drinking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone CounselingBehavioural
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.
Telephone AssessmentsBehavioural
Also called Survey, Questionnaire
4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.
| Study group | Role | What they receive |
|---|---|---|
| MAPS+ | Other | 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. Receives: Behavioral: Telephone Counseling; Behavioral: Telephone Assessments |
| MAPS | Other | MAPS (Motivation and Problem-Solving):
Counseling treatment approach with a focus on smoking cessation. Receives: Behavioral: Telephone Counseling; Behavioral: Telephone Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
Continuous outcome variables (including number of drinks per day, self-efficacy, etc.)
Measured: 2 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2007 (estimated)
- Study startDec 2007
- Primary completion22 Jul 2021
- Study completion22 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 370 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Lorna McNeill, MPH,PHD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00570804
- Sponsor's protocol ID
- 2005-0791
- Other IDs
- U54CA096300, U54CA096297, NCI-2012-02110
- Status last verified
- Jul 2021
- First submitted
- 7 Dec 2007
- Last updated
- 28 Jul 2021
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
- ClinicalTrials.gov ID
- NCT00570804
- Acronym / sponsor ID
- 2005-0791
- Conditions
- Smoking
- Keywords
- Smoking Cessation, Puerto Rico Quitline, Motivational Relapse Prevention, Oral Cancer, Risk Reduction, Tobacco Use, Alcohol Use, MAPS
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Dec 2007 (actual)
- Primary completion
- 22 Jul 2021 (actual)
- Study completion
- 22 Jul 2021 (actual)
- First posted
- 11 Dec 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Objectives:
- Assess MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
- Assess MAPS and MAPS+ effects on treatment mechanisms (increased self-efficacy, decreased temptations/craving, decreased stress and negative affect) and the role of those mechanisms in mediating MAPS and MAPS+ effects on alcohol at-risk behaviors and smoking cessation.
- Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAPS+ | Other | Behavioral: Telephone Counseling, Behavioral: Telephone AssessmentsMAPS+ (Motivation and Problem-Solving Plus): Counseling using specific treatment approach that focuses on combined smoking cessation and the reduction of at-risk alcohol use. |
| MAPS | Other | Behavioral: Telephone Counseling, Behavioral: Telephone AssessmentsMAPS (Motivation and Problem-Solving): Counseling treatment approach with a focus on smoking cessation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Current (daily) smoker requesting help for smoking cessation
- Exhibit at least one of the following criteria for at-risk drinking: a) an average of =/> 2 alcoholic beverages/day during the past 30 days for men or =/>1 drink/day for women, OR b) two or more occasions of consuming /=> 5 alcoholic beverages during the past 30 days for men or =/>4 drinks for women, OR c) in the past 30 days, driving after consuming =/>3 drinks.
- Age 18 or above
- Motivated to quit smoking in the next 30 days
- Viable (working) telephone number and home address
Key exclusion criteria (3 listed)
- Currently incarcerated or in jail
- Currently pregnant
- Score equal to or more than 16 on the Alcohol Use Disorders Identification Test (AUDIT) measure.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Counseling7 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. | Behavioural | MAPS, MAPS+ |
| Telephone AssessmentsAlso: Survey, Questionnaire4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete. | Behavioural | MAPS, MAPS+ |
Primary outcome
Continuous outcome variables (including number of drinks per day, self-efficacy, etc.)
Time frame: 2 Years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jul 2021.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lorna McNeill, MPH,PHD principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Telephone Counseling and Telephone Assessments in people with Smoking, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Continuous outcome variables (including number of drinks per day, self-efficacy, etc.) (time frame: 2 Years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2021.