Behaviors and Mental Disorders

All Conditions

Neoplasms

Mouth and Tooth Diseases

Rare Diseases

Alcohol Drinking

Mouth Neoplasms

Drinking Behavior

Oral Cancer

Lip and Oral Cavity Cancer

Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Ethanol

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.

MAPS (Motivation and Problem-Solving):

Counseling treatment approach with a focus on smoking cessation.

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 Counseling

4 assessment telephone calls at Weeks 12, 26 and 52 (interview by a research staff member), taking about 30 minutes each to complete.

Telephone Assessments

Lorna McNeill, MPH,PHD

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 on alcohol at-risk behaviors and smoking cessation.
3. Evaluate the cost-effectiveness of MAPS and MAPS+ in the reduction of at-risk drinking and smoking cessation.

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.

Combined Treatment for Tobacco and Alcohol Use in Puerto Rico

Oral Cancer Risk Reduction Through Combined Treatment for Tobacco and Alcohol Use

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

Nutritional and Metabolic Diseases

Symptoms and General Pathology

Obesity

Overweight

Overnutrition

Nutrition Disorders

Body Weight

Health Education \[HE\] - Counseling, referrals to resources + self-help materials; 2 HE interventions at Baseline + 6 month visits.

Motivation And Problem Solving (MAPS) - HE + 12 telephone counseling sessions over 1-year period (average 1 call/month).

Counseling, referrals to available resources and self-help materials on Day 1, at 6 and 12 month visits, along with surveys at 6 and 12 months.

Health Education

12 counseling phone calls over 1 year, lasting about 20-30 minutes.

MAPS

Lorna H. McNeill, PHD,MPH

The goal of this research study is to learn if a motivation and problem solving (MAPS) program can help improve diet and levels of physical activity in African Americans who are overweight.

Day 1 Study Visit:

If you are found eligible to take part in this study, the following tests and procedures will be performed on Day 1 (the same day you complete the screening tests and sign this consent form):

* You will complete a computer-based survey about your mood, diet, and physical activity. The survey should take about 90 minutes total to complete.
* Your blood pressure will be measured.
* Your height, weight, and waistline will be measured. To measure your waistline accurately, you may be asked to lift your shirt to expose your stomach area and to lower your pants to expose your mid-hip area. Waistline measurements will only take about 10 minutes to complete and will be performed in a private area.
* Your non-fasting blood glucose and cholesterol levels will be measured (with 2 small finger pricks).
* You will be asked to provide a 7-day record of your physical activity using a small device called an accelerometer. The accelerometer will be worn on your hip and measures the amount of physical activity you do. You will be given a prepaid envelope to return the accelerometer to the study staff.

Study Groups and Study Procedures:

At the Day 1 study visit, you will be randomly assigned (as in the flip of a coin) into 1 of 2 study groups.

If you are in Group 1 or 2, you will receive health education on Day 1, 6 months, and 12 months later. Health education includes:

* A brief counseling session with a study staff member to talk about diet and your physical activity levels
* Referrals to available resources for help with your diet and physical activity
* Self-help materials that are designed to help you learn how to improve your diet and physical activity

At Months 6 and 12, you will also:

* Complete the computer-based survey about your mood, diet, and physical activity.
* Have your height, weight, waistline and blood pressure measured.
* Your non-fasting blood glucose and cholesterol levels will be measured.
* Be given an accelerometer to wear for 7 days.You will be given a prepaid envelope to return the accelerometer to the study staff.

If you are in Group 2, you will also take part in the MAPS program. For the MAPS program, you will have 12 counseling phone calls over 1 year. Each of these phone calls will be digitally recorded and should last about 20-30 minutes. You may decline to have your counseling phone call recorded if it makes you feel uncomfortable. The purpose of the phone calls are to provide support to you on changes in your diet or physical activity and to answer any questions you may have about your program.

Length of Study:

You will remain on the study for up to 1 year. Your participation on this study will be over once you complete the study visit at Month 12.

Other Important Information:

You may be contacted by phone, mail, and/or email at any time while you are taking part in this study to be reminded about the study visits. You will be asked to give the names and contact information for family members and/or friends for the study staff to contact in the event there is trouble reaching you first.

If the accelerometer is lost or stolen, you will not be responsible for the replacement cost, but you should tell the study staff right away.

All participant's paper files will be stored in locked file cabinets and all data files will be stored in a password-protected databases. The information discussed during the counseling phone calls will be kept confidential. Only members of the research team will have access to the recordings.

This is an investigational study.

Up to 300 participants will take part in this study. All will be enrolled at MD Anderson.

16 saliva samples to be collected for hormone testing.

Obesity: Cancer Risk Among African Americans

Obesity: Cancer Risk Among African Americans-Developing Interventions Through Community Collaboration

Effects of MAPS on each of modifiable risk factors, assessed at 6 and 12-month follow-up visits using, using Questionnaire Design System (QDS), a computer-administered self-interview format.

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Uterine Cervical Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline. Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months.

Participants receive free self-help materials mailed at baseline, 6, and 12 months. Participants receive a referral to the Oklahoma Quitline.Participants receive a 12-week supply of the nicotine patch and lozenge. Nicotine patch regime based on participant's self-reported smoking rate. REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months. Saliva test performed at 3, 6, 12, and 18 months. 6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.

Participants receive free self-help materials mailed at baseline, 6, and 12 months. and a referral to the Oklahoma Quitline.

Self-Help Materials

Participants receive a 12-week supply of nicotine patch. Nicotine patch regime based on participant's self-reported smoking rate. Participants who smoke \>10 cigarettes/day receive 8 weeks of 21 mg, 2 week of 14 mg, and 2 week of 7 mg patches. Those who smoke \<10 cigarettes/day receive 8 weeks of 14 mg and 4 weeks of 7 mg patches.

Nicotine Patch

REDCap will be used to collect all questionnaires data over the phone. Questionnaires done at baseline to randomize, then at 3, 6, 12, and 18 months.

REDCap

Saliva test performed at 3, 6, 12, and 18 months.

Saliva Test

6 telephone counseling sessions performed over 12 months. Sessions performed at baseline, 3, 6, 12, and 18 months. Sessions digitally recorded.

Telephone Counseling Sessions

Participants receive a 12-week supply of nicotine lozenges. All participants receive 12 weeks of 2mg lozenges.

Nicotine lozenge

Jennifer Vidrine, PHD

The goal of this research study is to compare a program called Motivation And Problem-Solving (MAPS) to the standard treatment to help participants with a history of cervical cancer or high-grade cervical dysplasia quit smoking.

Study Groups:

If you agree to take part in this study, you will be randomly assigned to 1 of 2 possible study groups. Randomization means that you are put in a group by chance, like the flip of a coin. A computer program will make this random assignment.

* If you are in Group 1, you will receive free self-help materials, and a referral to the Quitline.
* If you are in Group 2, you will receive free self-help materials, a referral to the Quitline, and 6 telephone counseling sessions over the next year. The Quitline provides free quit smoking services to eligible callers.

No matter which group you are in, you will also receive a 12-week supply of nicotine replacement therapy. The strength of the nicotine patches and lozenges you receive will depend on how much you smoke each day. You should use the nicotine patch as directed by the package instructions.

Unused and used patches have enough nicotine to poison children and pets. Be sure to fold the sticky ends together when you are done using the patch. In case of accidental overdose, call your doctor or a poison control center right away.

Even if you do not wish to use the nicotine patch, you will still be allowed to take part in the study.

Study Questionnaires:

You will be asked to complete questionnaires over the phone 5 times:

* Baseline
* Month 3
* Month 6
* Month 12
* Month 18

You will be asked about your feelings, moods, cervical cancer or dysplasia diagnosis, and smoking status. These calls should take about 45 minutes each time to complete.

Saliva Testing:

At Months 3, 6, 12 and 18, you may also be asked to provide a saliva sample to test for cotinine to confirm your smoking status. Cotinine is a chemical released in your body when it breaks down nicotine. You will receive a kit in the mail with supplies for testing. The research staff will call you to make sure that you received the kit and to discuss the instructions with you. If you have any questions about how to use the kit, you may contact the study staff during the study.

To collect the saliva, you will put a small piece of cotton in your mouth for a few minutes. You will be asked to mail the saliva sample back to the research staff, using a prepaid return envelope. You may be contacted by mail, telephone, and/or email during the study to be given reminders to send back the kit.

Telephone Counseling:

If you are in Group 2, you will have 6 telephone counseling sessions that may last up to 30 minutes each. These calls will occur over a 12-month period at times that are convenient for you. During the calls, you will be asked about how motivated you are to quit smoking, what barriers to quitting you may have, and factors that may be related to your smoking such as stress and family issues.

These sessions will be digitally recorded. The recordings will be used to help the researchers make sure that the counselors are following the correct procedures and to help the investigators better understand or improve the counseling.

Length of the Study:

Your participation in the study will end when you complete the final questionnaire call at Month 18.

If you wish to leave the study early, you should tell the study staff that you want to stop taking part in this research study. Once you tell the study staff that you want to stop participating, you will not receive follow-up questionnaire phone calls.

This is an investigational study. The nicotine patch used in this study is FDA approved and commercially available.

Up to 455 participants overall will take part in this research study.

In-Depth Interviews:

If you agree to take part in this study, you be asked to complete a questionnaire and will participate in an in-depth interview.

Demographic and Smoking History Questionnaire:

At the time of your visit you will be asked to complete a questionnaire in efforts to collect demographic and smoking history information. You may refuse to answer any question that makes you feel uncomfortable. The questionnaire may take up to 10 minutes to complete.

In-depth Interview:

You will be asked to discuss various parts of a new program designed to help women with cervical cancer quit smoking. You will be asked your thoughts on how important you think the program is, your feelings about it, and if you like it. The interview is designed to be done in a non-threatening, non-judgemental, and supportive way.

The interview should last about 2 hours.

In-depth interviews will be audio recorded and transcribed (written down).

Your participation in this study will be over when you complete the interview.

This is an investigational study.

Up to 30 women will take part in the interviews.

Up to 350 participants overall will take part in this research study. All will be enrolled at the Stephenson Cancer Center.

Smoking Cessation for Cervical Cancer Survivors

Smoking Cessation for Cervical Cancer Survivors in a Safety Net Healthcare System

To test treatment effect at 18 months, logistic regression analysis conducted with abstinence as outcome variable, and treatment (a two-level categorical variable) as predictor, adjusting for covariates, specifically, factors used in the minimization procedures (race/ethnicity, language, age, education, income, cigarettes/day, cervical cancer stage, and time since diagnosis). A logit link and binomial variance function assumed for generalized linear mixed model (GLMM), regression and parameterize them with blocking on individual nested within treatment conditions. Treatment and time included, as well as their interaction, with adjustment for relevant covariates.

H. Lee Moffitt Cancer Center and Research Institute

Adverse events were not collected or assessed as part of this study.

Standard Treatment (ST) consists of a mailed packet of materials including a letter referring smokers to the Oklahoma Tobacco Helpline, Florida Quitline or to the national quitline number (1-800-QUIT-NOW) for participants residing in other states, free nicotine replacement therapy when ready to quit, and standard self-help materials. ST will be mailed a total of 3 times to participants with completed assessments (Baseline, 6 and 12 months).

Standard Treatment (ST)

Motivation + Problem Solving (MAPS) consists of ST plus up to 6 proactive telephone counseling sessions delivered over a 12-month period. Telephone assessments across all treatment conditions will be administered at baseline and 3, 6, 12 and 18 months after baseline. The primary outcome is abstinence from tobacco at 18 months and the secondary outcomes are abstinence at other assessments, as well as quit attempts, cigarettes per day, use of the quitline across all post-baseline assessments, and cost-effectiveness.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico	NCT00570804	Smoking	Telephone Couns... Telephone Asses...	18 Years -	M.D. Anderson Cancer Center
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico	NCT00570804	Smoking	Telephone Couns... Telephone Asses...	18 Years -	M.D. Anderson Cancer Center
Combined Treatment for Tobacco and Alcohol Use in Puerto Rico	NCT00570804	Smoking	Telephone Couns... Telephone Asses...	18 Years -	M.D. Anderson Cancer Center
Obesity: Cancer Risk Among African Americans	NCT01294657	Cancer Obesity	Health Educatio... MAPS	18 Years - 65 Years	M.D. Anderson Cancer Center
Smoking Cessation for Cervical Cancer Survivors	NCT02157610	Cervical Cancer Tobacco Use Smoking Cessati...	Self-Help Mater... Nicotine Patch REDCap Saliva Test Telephone Couns... Nicotine lozeng...	18 Years -	H. Lee Moffitt Cancer Center and Research Institute

Spots Global Cancer Trial Database for maps

Every month we try and update this database with for maps cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for maps

Every month we try and update this database with for maps cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for maps cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.