Anti-Infective Agents

Central Nervous System Depressants

All Drugs and Chemicals

Central Nervous System Stimulants

Ethanol

Nicotine

Carbon Monoxide

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Antimetabolites

Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participant and counselor discuss how smoking and their culture may relate to each other. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Participants receive additional talks related to smoking cessation tailored to their culture. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Participants receive 4 weeks of 21 mg, 4 weeks of 14 mg, and 4 weeks of 7 mg patches.

Nicotine Patch

Questionnaires regarding tobacco and alcohol use, culture, religion, and sense of control completed at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.

Questionnaires

Carbon monoxide (CO) test given at baseline, at weeks 2 and 6, and at 3 and 6 months after baseline.

Carbon Monoxide (CO) Test

Participants receive general health education and handouts.

Health Education and Handouts

Participants given reading materials that highlight how aspects of their culture relate to health, smoking and quitting.

Culturally Tailored Reading Materials

Participants attend 3 counseling sessions during the study.

Counseling Sessions

Marcel A. de Dios, PHD

The goal of this research study is to learn how 3 different kinds of counseling treatments may help individuals to quit smoking.

Baseline Visit:

If you agree to take part in this study, the following tests and procedures will be performed at the beginning of the study:

* You will complete 10 questionnaires about your demographics (age, race, sex, and so on), medical history, smoking status, alcohol use, religion, how "in control" you feel of your own life, and cultural background. These should take about 1½ hours to complete.
* You will complete a carbon monoxide (CO) test to measure the level of carbon monoxide in your body. This test involves blowing your breath through a hand-held device.
* You will learn how to keep a diary about your progress in your attempts to quit smoking. °You must bring this diary with you to every visit.
* You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.
* If you can become pregnant, you will have a urine pregnancy test. To take part in this study, you must not be pregnant.3
* The total length of the baseline visit will be approximately 2.5 hours.

Study Groups:

You will be randomly assigned (as in the roll of dice) into 1 of 3 study groups. You will have an equal chance of being in each group. This is done because no one knows if one study group is better, the same, or worse than the other group.

Counseling Sessions:

The study group that you are in will determine the way that health information is presented to you in one-on-one counseling sessions.

* If you are in Group 1, you will receive general health education. The counselor will discuss a health topic (such as sleep, nutrition, and exercise) and how it relates to you and your smoking. The counselor will also give you handouts about the health topic.
* If you are in Group 2, you and the counselor will discuss how your smoking and your culture may relate to each other. The counselor will also provide you with reading materials that highlight how aspects of your culture relate to health, smoking and quitting.
* If you are in Group 3, you will receive the same cultural counseling and handouts that Group 2 received. Also, you will have additional talks about the use of drugs to help you stop smoking and some common feelings that Latinos may experience with being unsuccessful when trying to quit. The counselor will also offer you a plan for using medication successfully.

All participants will attend 3 counseling sessions during the study. Each of these counseling sessions will be audio recorded. Your first counseling session will be at baseline. The other two counseling sessions will be at your Week 2 and Week 6 visits (described below).

All participants will be given a 12 week supply of nicotine patches and information about how to use the nicotine patch. At each study visit, you will be given the amount of patches that you need to last you to your next visit, plus a few extra in the event that a patch falls off or is damaged.

During your first counseling session, you will be asked to choose a quit date. This is simply a date that you would like to begin using the patch and make an attempt to not smoke.

Week 2 and Week 6 Study Visits:

At each of these study visits, all participants will have the following procedures:

* You will complete a brief interview about your progress and any side effects you may be having. This should take about 10 minutes to complete.
* You will complete 2 questionnaires about your tobacco use and satisfaction with the study. These should take about 10 minutes to complete.
* You will complete a CO test.
* You will be asked if you have smoked any other substances, such as marijuana, in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

Follow-Up Visits:

About 3 months and 6 months after baseline, you will have a follow-up visit. At each of these visits, the following tests and procedures will be performed:

* You will complete the same set of questionnaires about your tobacco and alcohol use, culture, religion, and sense of control that you did at your baseline visit.
* You will complete a CO test.
* You will be asked if you have smoked any non-tobacco substances in the last 2 days. If you have, you will provide an additional CO sample 2 days after the last time you smoked the substance.

Length of Study:

Your study participation will be over after you complete the 6-month follow-up visit.

This is an investigational study. Up to 36 people will be enrolled in this study. All will take part at MD Anderson.

Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers

The central aim of this pilot study was to evaluate the feasibility and acceptability of our treatment interventions. As such, we examined between-group differences on session satisfaction. After completing each session, participants anonymously rated their level of satisfaction with the counseling session. This investigator created scale (Session Satisfaction Scale) used a 5-point Likert scale (from 1 = "Extremely Unsatisfied" to 5 = "Extremely Satisfied"). Mean satisfaction scores were computed for each participant as the average of all session satisfaction scores. Higher scores indicating greater levels of satisfaction. Treatment group session satisfaction group means were tabulated by group (calculated as the average for all participants in each treatment group) and used as a proxy measure of overall intervention acceptability and feasibility.

Adherence to NRT patch (days of NRT patch use) collected with the Timeline followback interview procedure.

Rates of biochemically verified 7-day point prevalence smoking abstinence. Collected with the Timeline Follow-back interview procedure and verified with a expired carbon monoxide testing with a Bedfont Smokelyzer monitor.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

MD Anderson requires that all Protocol PIs and their designees report all Serious Adverse Events and Adverse Events (n=4) to the MD Anderson IRB on an ongoing bases using a systematic approach with standardized forms. SAE's and AE's are reported as they occur and during each continuation reports submission.

Used as the control condition. Participants receive general health education and handouts. Participants attend 3 counseling sessions during the study. Each of these counseling sessions are audio recorded. Counselor discusses a health topic (such as sleep, nutrition, and exercise) and how it relates to participant and their smoking. Participants receive 12 weeks of Nicotine Replacement Therapy (NRT).

Health Education (HE)

Culturally-Tailored (CT)

Culturally-Tailored With Adherence Enhancement (CT+AE)

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Due to the limited scope, the study was not fully powered for conclusive hypothesis testing of group differences on variables of interest. The analytic strategy focused on descriptive statistics and estimation rather than formal hypothesis testing.

Dr. Marcel A. de Dios / Health Disparities Research

Intervention Feasibility & Acceptability

Patch Adherence: Percentage of Days With Patch

3-month follow-up

6-month follow-up

Number of Abstinent Participants

Overall Study

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All 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

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.

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.

Motivation + Problem Solving (MAPS)

Jennifer Vidrine, PhD, MS

Percentage of Participants With Smoking Abstinence

Skin and Connective Tissue Diseases

Skin Neoplasms

Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter.

Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education. Participants given handouts that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.

Participants complete 1 questionnaire at beginning of study, 1 after receiving education about how to protect skin from sun and how to avoid tanning beds, and 1 at about 3 months after receiving skin protection education.

At beginning of study, 2 photos taken of the face. One photo is a standard photo, the other photo is taken with an ultraviolet (UV) filter.

Photos

At beginning of study, handouts given that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.

Pamphlets

Susan Peterson, MPH,PHD

The goal of this research study is to learn how students react to seeing a photograph of any skin damage they may have on their face. This skin damage may be caused by sun exposure or use of tanning beds. Researchers also want to learn about students' sun protection, tanning behaviors, and attitudes towards sun exposure, sun protection, tanning behaviors and skin cancer.

Researchers will use the results of this study to design programs for students about sun protection and tanning avoidance.

If participant agrees to take part in this study, they will complete 3 questionnaires about sun protection, tanning behaviors, sunburns, and attitudes and opinions about sun exposure, sun protection, tanning behaviors and skin cancer.

Participant's school will be assigned to 1 of 2 possible groups:

* If participant's school is assigned to Group 1, they will have 2 photos taken of their face. One (1) photo is a standard photo (like the kind one may take with a regular camera). The other photo is taken with an ultraviolet (UV) filter and shows skin damage that cannot be seen in a standard photo.
* If participant's school is assigned to Group 2, they will not have any photos taken.

If participant is in Group 1, they and a member of the study staff will compare the standard and UV photographs together. The study staff will discuss any skin damage seen with participant. A member of the study staff will record on a paper form any visible reactions participant may have to viewing their UV photograph. Participant will also be given a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds. Participant will see their photos on a computer screen. Participant will not be given their photos. At the end of this study, the photos will be deleted.

If participant is in Group 2, they will only receive a handout that discusses skin cancer prevention, sun protection, and how to avoid tanning beds.

All participants will complete 1 questionnaire at the beginning of the study (before receiving any kind of education about skin cancer prevention), 1 questionnaire after receiving education about how to protect participant's skin from the sun and how to avoid tanning beds, and 1 questionnaire at about 3 months after receiving the education about how to protect skin from the sun and how to avoid tanning beds.

Participant will complete these study procedures at school and they may answer some of the questionnaires outside of school. Participant will complete the first questionnaire on paper at their school. Participant will have an option to complete this questionnaire online if they are not able to complete it on paper the day the study team visits their school. Participant will complete the second questionnaire on paper at their school. Participant will complete the third questionnaire online. Links to the online questionnaires will be sent to the email address that participant will provide on the Participant Contact Information Form. Participant will also have an option to receive a link to the questionnaire via text message if they provide us with a cell phone number that can receive text messages on the Participant Contact Information Form. Participant may incur charges for receiving text messages.

Length of Study:

Student's participation in this study will be over after they have completed the last questionnaire. It will take about 1 hour to complete all study questionnaires and procedures.

This is an investigational study.

Up to 420 participants will be enrolled in this study. All will take part through MD Anderson at different schools in the greater Houston area.

Only about 35 participants will be able to take part at each school. This means that even if participant agrees, they may not be selected to take part in this study. The student participants will be randomly selected from the pool of students who agree to participate.

Ultraviolet (UV) Photography in Adolescents

Sun Protection, Tanning Behaviors and Attitudes in Adolescents

Baseline sun protection behaviors are assessed using self-reported measures of sun protection behaviors. Both the baseline and 3-month behavior composite scores range from 1 to 5 and are calculated as the mean of the four sun protection behavior items.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Project Impact 2: A Culturally Tailored Smoking Cessation Intervention for Latino Smokers	NCT02596711	Tobacco Use Ces... Cancer Preventi...	Nicotine Patch Questionnaires Carbon Monoxide... Health Educatio... Culturally Tail... Counseling Sess...	18 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
Ultraviolet (UV) Photography in Adolescents	NCT02426853	Cancer Preventi...	Questionnaires Photos Pamphlets	12 Years - 14 Years	M.D. Anderson Cancer Center

Spots Global Cancer Trial Database for pamphlets

Every month we try and update this database with for pamphlets 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 pamphlets

Every month we try and update this database with for pamphlets 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 pamphlets 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.