Head and Neck CancerNCT00799669
Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
An observational study of Head and Neck Cancer and Tobacco Use Disorder, run by M.D. Anderson Cancer Center.
Trial summary
RATIONALE: A counseling program that motivates patients to stop smoking and drinking may reduce the risk of oral cancer. It is not yet known whether motivational stop smoking counseling or motivational stop-smoking and stop drinking counseling is more effective in helping patients stop smoking and drinking. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer, Tobacco Use Disorder
- What is being tested?
- smoking cessation intervention, counseling intervention and preventive intervention
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 370 participants
- Where
- No sites listed yet
- Study dates
- 5 Dec 2007to Feb 2020
- Phase
- Observational
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult Smokers Residing in Puerto Rico
DISEASE CHARACTERISTICS:
- Current daily smoker
- Called the Puerto Rico Quitline
- Motivated to quit smoking in the next 30 days
- Exhibits at least one of the following criteria for at-risk drinking:
- An average of ≥ 2 alcoholic beverages/day for men or ≥ 1 drink/day for women in the past 30 days
- Two or more occasions of consuming ≥ 5 alcoholic beverages/day for men or ≥ 4 drinks/day for women in the past 30 days
- Driving after consuming ≥ 3 drinks in the past 30 days
- Score of ≤ 15 on the Alcohol Use Disorders Identification Test
PATIENT CHARACTERISTICS:
- Not pregnant
- Residing in Puerto Rico
- Not currently incarcerated or in jail
- No other household member enrolled in this study
- Viable telephone number and home address
- Willing to provide the names, addresses, and phone numbers of up to 3 collaterals
PRIOR CONCURRENT THERAPY:
- Not specified
About this study
RATIONALE: A counseling program that motivates patients to stop smoking and drinking may reduce the risk of oral cancer. It is not yet known whether motivational stop smoking counseling or motivational stop-smoking and stop drinking counseling is more effective in helping patients stop smoking and drinking.
PURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and drinking works in preventing oral cancer in smokers in Puerto Rico.
Read the detailed description
OBJECTIVES:
- To evaluate the effects of a motivational and problem-solving smoking cessation (MAPS) and a motivational and problem solving approach on at-risk alcohol use and smoking cessation (MAPS+) among Puerto Rican at-risk drinkers/smokers who call the Puerto Rico Quitline (PRQ).
- To assess effects of MAPS and MAPS+ on treatment mechanisms and the role of those mechanisms in mediating these effects on at-risk drinking and smoking cessation.
- To evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
OUTLINE: Minimization randomization is applied using the following variables: age, gender, cigarettes/day, number of drinks/day, and depression (score on the Center of Epidemiologic Studies Depression Scale). Patients are randomized to 1 of 2 intervention arms.
- Arm I (MAPS): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS approach includes motivational interviewing and cognitive behavioral/problem-solving that focus on smoking cessation.
- Arm II (MAPS+): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS+ approach includes motivational interviewing and cognitive behavioral/problems solving that focus on smoking cessation and the reduction of at-risk alcohol use.
In both arms, patients receive counseling calls over 15-30 minutes the week before quit date (QD), on QD, 3-5 days after QD, 7-10 days after QD, 15-30 days after QD, 45-60 days after QD, and on day 90 after QD. Patients complete questionnaires for alcohol- and smoking-related measures, self efficacy, stress/negative affects/depression, social support, and physical activity at baseline and weeks 12, 26 and 52 after QD.
- Conditions
- Head and Neck Cancer, Tobacco Use Disorder
- Being tested
- smoking cessation intervention, counseling intervention, preventive intervention, questionnaire administration
- Keywords
- hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, tobacco use disorder
- Medical subject headings
- Head and Neck Neoplasms, Tobacco Use Disorder, Hypopharyngeal Neoplasms, Laryngeal Neoplasms, Mouth Neoplasms, Nasopharyngeal Neoplasms, Oropharyngeal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
smoking cessation interventionBehavioural
Standard quit-smoking counseling to help decrease their risk of cancer.
counseling interventionOther
Counseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use.
preventive interventionOther
questionnaire administrationOther
Also called survey
| Study group | Role | What they receive |
|---|---|---|
| MAPS+ | 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: smoking cessation intervention; Other: counseling intervention; Other: preventive intervention; Other: questionnaire administration | |
| MAPS | MAPS (Motivation and Problem-Solving):
Counseling treatment approach with a focus on smoking cessation. Receives: Behavioral: smoking cessation intervention; Other: questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant At-risk drinking status
Measured: 52 weeks
Smoking cessation
Measured: 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study start5 Dec 2007
- Primary completionFeb 2020 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck CancerStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- 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
- David Wetter, PhD, MS, BA, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799669
- Sponsor's protocol ID
- CDR0000626365
- Other IDs
- MDA-2005-0791, CDR0000626365, U54CA096300, U54CA096297, NCI-2012-02110
- Status last verified
- Nov 2018
- First submitted
- 27 Nov 2008
- Last updated
- 8 Nov 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use
- ClinicalTrials.gov ID
- NCT00799669
- Acronym / sponsor ID
- CDR0000626365
- Conditions
- Head and Neck Cancer, Tobacco Use Disorder
- Keywords
- hypopharyngeal cancer, laryngeal cancer, lip and oral cavity cancer, nasopharyngeal cancer, oropharyngeal cancer, paranasal sinus and nasal cavity cancer, tobacco use disorder
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 370 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 5 Dec 2007 (actual)
- Primary completion
- Feb 2020 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 1 Dec 2008 (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.
RATIONALE: A counseling program that motivates patients to stop smoking and drinking may reduce the risk of oral cancer. It is not yet known whether motivational stop smoking counseling or motivational stop-smoking and stop drinking counseling is more effective in helping patients stop smoking and drinking.
PURPOSE: This randomized clinical trial is studying how well treatment to stop smoking and drinking works in preventing oral cancer in smokers in Puerto Rico.
Detailed description
OBJECTIVES:
- To evaluate the effects of a motivational and problem-solving smoking cessation (MAPS) and a motivational and problem solving approach on at-risk alcohol use and smoking cessation (MAPS+) among Puerto Rican at-risk drinkers/smokers who call the Puerto Rico Quitline (PRQ).
- To assess effects of MAPS and MAPS+ on treatment mechanisms and the role of those mechanisms in mediating these effects on at-risk drinking and smoking cessation.
- To evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.
OUTLINE: Minimization randomization is applied using the following variables: age, gender, cigarettes/day, number of drinks/day, and depression (score on the Center of Epidemiologic Studies Depression Scale). Patients are randomized to 1 of 2 intervention arms.
- Arm I (MAPS): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS approach includes motivational interviewing and cognitive behavioral/problem-solving that focus on smoking cessation.
- Arm II (MAPS+): Patients receive culturally sensitive self-help materials tailored for alcohol and tobacco users and 7 telephone counseling calls. The MAPS+ approach includes motivational interviewing and cognitive behavioral/problems solving that focus on smoking cessation and the reduction of at-risk alcohol use.
In both arms, patients receive counseling calls over 15-30 minutes the week before quit date (QD), on QD, 3-5 days after QD, 7-10 days after QD, 15-30 days after QD, 45-60 days after QD, and on day 90 after QD. Patients complete questionnaires for alcohol- and smoking-related measures, self efficacy, stress/negative affects/depression, social support, and physical activity at baseline and weeks 12, 26 and 52 after QD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MAPS+ | – | Behavioral: smoking cessation intervention, Other: counseling intervention, Other: preventive intervention, Other: questionnaire administrationMAPS+ (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 | – | Behavioral: smoking cessation intervention, Other: questionnaire administrationMAPS (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
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult Smokers Residing in Puerto Rico
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 |
|---|---|---|
| smoking cessation interventionStandard quit-smoking counseling to help decrease their risk of cancer. | Behavioural | MAPS, MAPS+ |
| counseling interventionCounseling focusing on decreasing risk of getting cancer by decreasing smoking and alcohol use. | Other | MAPS+ |
| preventive intervention | Other | MAPS+ |
| questionnaire administrationAlso: survey | Other | MAPS, MAPS+ |
Primary outcome
Participant At-risk drinking status
Time frame: 52 weeks
Smoking cessation
Time frame: 52 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2018.
- University of Texas MD Anderson Cancer Center Official WebsiteLink provided by the sponsor.
- National Cancer Institute (NCI) Central Website for Cancer ResearchLink 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.
David Wetter, PhD, MS, BA study chair
M.D. Anderson Cancer Center
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer and Tobacco Use Disorder, run by M.D. Anderson Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: status not confirmed, as of the sponsor's last update on 8 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Participant At-risk drinking status (time frame: 52 weeks). The study lists 2 primary outcomes in all. 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 8 Nov 2018.