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

Vaccines

Nicotine

Four separate Facebook groups, which provide information via posts within the private groups about cancer risk factors (e.g. reducing alcohol consumption, tobacco use cessation, increasing physical activity), behavioral skills to reduce them, benefits of, social support for, and ways to reduce social/financial costs of cancer prevention, and advice from health care providers to decrease barriers. Posts will seek to improve self- and response-efficacy and perceived risk, and link cancer prevention to personal goals.

Participants, aged 18-26, will join a private Facebook group to participate in the intervention. The group is not viewable to the public, including other Facebook users. Content that focuses on cancer prevention behaviors will be posted twice per day for up to 12 months. Each group will be hosted by a moderator who is responsible for managing the intervention goals and participants' engagement.

4 Corners Rural Health Cancer Prevention

David Buller, PhD

Young adults aged 18-26 engage in a number of behaviors that increase their risk of developing cancer later in life including sedentary lifestyles, unhealthy eating, nicotine produce us, heavy drinking of alcohol, increased UV exposure, and incomplete uptake of HPV vaccination. A multi-risk factor campaign will be developed to reduce these cancer risk behaviors and delivered to young adults over social media, a popular channel that can reach nearly all young adults. The campaign will be evaluated for effectiveness in a rigorous randomized trial with measures of moderate to vigorous physical activity, healthy eating patterns, nicotine product use, alcohol intake, sunburn prevalence, and HPV vaccination uptake.

Several risk factors are prevalent during early adulthood that can lead to cancer later in life. Emerging adults (EAs) aged 18-26 residing in rural areas of the United States engage in many cancer risk behaviors, especially sedentary lifestyles, poor eating patterns, nicotine product use, excess alcohol intake, infrequent sun protection, and inadequate uptake of the HPV vaccine. This application responds to RFA-CA-20-051, "Social and Behavioral Intervention Research to Address Modifiable Risk Factors for Cancer in Rural Populations." The goal is to improve cancer risk behavioral factors among diverse EAs aged 18-26 living in rural counties in the Four Corners states, a unique, underserved region, using a social media campaign designed with community advisors. EAs, including in rural communities, are heavy consumers of online content, especially over social media, and social media provide responsive, engaging, and low-cost platforms for distributing cancer prevention information with high dissemination potential. But, social media also circulate inaccurate, misleading, and harmful information. The specific aims of this research are to: 1) Develop a social media intervention for diverse EAs in rural communities via a community-engaged process that combines expert advice, user-generated content, and online instruction to communicate about behavioral cancer risks, cancer misinformation, counter marketing, digital and media literacy, and family communication; 2) evaluate the effect of a theory-based social media intervention on moderate to vigorous physical activity (MVPA), healthy eating patterns, nicotine product use, alcohol intake, sunburn prevalence, and HPV vaccination with the diverse population of EAs aged 18-26 in rural counties in AZ, CO, NM, and UT (Four Corners states) recruited from Qualtrics' survey panel and enrolled in a pragmatic randomized trial using a stepped-wedge design in which individual EAs will be randomized to 1 of 4 cohorts and receive the social media feed for varying durations in separate Facebook private groups; 3) test if improvements in EAs' cancer risk knowledge and beliefs, digital and media literacy skills, accurate cancer prevention information, and family communication mediate impact of the social media campaign; and 4) explore whether the impact of the social media campaign differs according to: a) level of EAs' engagement with campaign, b) cancer risk factors, and c) biological sex of the participants (as required by NIH). The research is innovative because it tests a theory-based, multi-risk factor approach to cancer prevention with diverse EAs in rural counties, an under-studied population, in a very popular new media. Social media may reach EAs more than interventions through other community channels (e.g., clinics, schools, and workplaces) and for lower cost in the geographically-dispersed, underserved rural communities in the Mountain West. The overall impact is extremely high because it will aid rural EAs in making informed decisions that reduce cancer risk factors and prevent cancer later in life and help EAs critically evaluate and resist misinformation and marketing that promote cancer risk behaviors.

Randomized stepped-wedge with four cohorts

Cancer Prevention for Young Rural Adults

#4Corners4Health: A Social Media Cancer Prevention Program for Rural Emerging Adults

Participants will self-report minutes per week of moderate to vigorous physical activity.

Participants will self-report intake per day of fruits, vegetables, whole grains/fiber, added sugars (from sugar-sweetened beverages), and red/processed meats.

Participants will self-report tobacco/nicotine use in the past 30 days (every day, some days, not at all).

Participants self-report consumption of number of alcoholic drinks in the past 30 days.

Participants will self-report number of sunburns.

Participants will self-report whether or not they have received one or more doses of the HPV vaccine.

Participants will self-report number of minutes per week engaging in physical activity to determine if they meet the 150 minutes per week recommendation.

Participants will self-report frequency of eating meals away from home/fast food.

Participants will self-report tobacco/nicotine use in the past 7 days (every day, some days, not at all).

Participants will self-report readiness to quit using a 10 point rating scale (1=no thought of quitting; 10=taking action to quit).

Participants will self-report number of times binge drinking in the past 30 days.

Participants will self-report sun protection behaviors with percent of sun exposure hours using sun protection.

Participants will self-report if they have completed the series of HPV vaccination by receiving 3 doses of the vaccine.

University of Arizona

University of Utah

Colorado State University

University of Colorado, Denver

University of New Mexico

Klein Buendel, Inc.

Digestive System Diseases

Carcinoma, Squamous Cell

Gastroesophageal Reflux

Neoplasms, Squamous Cell

Carcinoma

Head and Neck Neoplasms

Mouth Diseases

Stomatognathic Diseases

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Complement System Proteins

From PLCO and ACS CPS II, identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),

From PLCO and ACS CPS II, we have identified 140 UADSCC cases. These cases are frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO),

The sequence-based approach is selected because it classifies samples by considering the entire difference (genetic distance) in 16S rRNA gene sequences among samples analyzed, unbiased by artificial details such as taxonomies, sequence length, or even quality scores.

Classification of Oral Microbiome Using 16S rRNA gene sequence-based approach

The taxonomic approach is a complement to the sequence-based approach in that it will further identify specific taxonomic groups or species that can explain the difference found by overall analyses.

Classification of Oral Microbiome Using taxonomic approach

Jiyoung Ahn, MD

The human oral cavity is a diverse habitat that contains approximately 700 prokaryotic species. The oral microbiome is comprised of 44% named species, 12% isolates representing unnamed species, and 44% phylotypes known only from 16S rRNA based cloning studies (http://www.homd.org/). Species from 11 phyla have been identified: Firmicutes, Bacteroidetes, Proteobacteria, Actinobacteria, Spirochaetes, Fusobacteria, TM7, Synergistetes, Chlamydiae, Chloroflexi and SR1 (http://www.homd.org/). Because these observations have been mainly based on data generated from traditional Sanger sequencing, the diversity of oral microbiome is highly likely underestimated. Application of high throughput sequencing to the oral microbiome similar to the scale of the microbiome studies of other body sites (GI tract, skin, and vagina) under the Human Microbiome Project is necessary to obtain data essential for understanding the diversity and community structure of the oral microbiome in health and disease.

The Prostate, Lung, Colorectal and Ovarian (PLCO) Cancer Screening Trial and The American Cancer Society Cancer Prevention Study II (CPS-II) investigators have identified 140 UADSCC cases that have been frequency matched 3:1 (420 controls) by incidence density sampling for study (ACS. PLCO), gender, ethnic background, and age, within 10 years.

140 UADSCC cases and 420 controls using Roche 454 16S rRNA gene sequencing.

The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer

Data alignment and clustering to determine microbiome species diversity

National Institutes of Health (NIH)

NYU Langone Health

The TRAC intervention focuses on increasing motivation and building skills to reduce alcohol use and involves 4, 30-minute sessions with an interventionist done via video chat or phone.

Participants will complete smartphone-based self-monitoring of alcohol use. Each morning, participants complete a mobile survey indicating if they drank the previous day and if so, how many drinks they had. Surveys will be programmed using REDcap and sent via a link in the reminder text message. Additionally, participants will be prompted each evening and asked to complete a breathalyzer reading using a mobile app to determine blood alcohol content (BAC). If safety concerns are identified (e.g., BAC ≥0.30; blackouts), the interventionist will refer the AYA to a licensed provider with expertise in substance use treatment.

Participants in the control group will receive educational materials regarding alcohol consumption and its link to cancer . They will also participate in smartphone monitoring of alcohol use on the same schedule as participants in the intervention group. This will allow us to compare daily alcohol use data between the two conditions and evaluate the added component of weekly counseling in TRAC.

The TRAC intervention focuses on increasing motivation and building skills for avoiding triggers and managing situations that encourage alcohol consumption. Participants set goals for reducing their drinking and learn strategies to help them achieve those goals. It requires four 30-minute sessions with a counselor using mobile phones.

TRAC: Tracking and Reducing Alcohol Consumption

The comparison group will be evaluated based on daily self-monitoring data.

No intervention

Carolyn Lauckner, PhD

The objective of this study is to adapt and test the feasibility of a 4-week motivational interviewing mHealth intervention, Tracking and Reducing Alcohol Consumption (TRAC), to reduce alcohol use among rural adolescent and young adult (AYA) cancer survivors during post-treatment survivorship.

At the end of this study, the feasibility data gathered will inform a definitive randomized controlled trial of TRAC-AYA to test the efficacy of the adapted intervention.

For this study, the investigators will adapt and pilot an existing mHealth intervention (TRAC) to reduce alcohol use among rural AYAs as part of a randomized controlled trial. TRAC includes weekly phone sessions with an interventionist and incorporates smartphones for daily self-monitoring of alcohol use. Upon enrollment, participants will be randomized into either the intervention (TRAC) arm or control (education and daily self-monitoring) arm.

Researchers will conduct the study in Kentucky, which leads the nation in cancer incidence and mortality, has a higher incidence of AYA cancers compared to other states, is 40% rural, and encompasses over 100 medically underserved areas. Participants will be recruited from the University of Kentucky Markey Cancer Center and its affiliate institutions.

Preliminary data used for this study were collected from a study (PI: Lauckner, K01AA02530) testing the TRAC intervention with people living with HIV/AIDS, which has shown promising preliminary results, with high feasibility, acceptability, and encouraging preliminary outcomes.

Evaluating an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors

Pilot Test of an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors

This outcome will be measured using participants' self-reported alcohol use on a 4-item survey. This will assess whether any alcohol was consumed, the number of drinks, time since last drink, and plans to drink later in the day. Higher reports of daily drinking indicate greater consumption of alcohol.

This will be measured using the BACTrack Mobile Pro breathalyzer, with results being sent to the study team via mobile app. Higher blood alcohol content indicates greater consumption of alcohol.

This will be measured using the PROMIS SF Alcohol 7a, which is a 7-item questionnaire used to assess alcohol use over the past 30 days.

Raw scores can range from 7-35. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates more alcohol use in the past 30 days.

This will be measured using the PROMIS-29 plus 2 v2.1, a 31 item scale which provides an overall profile of health with sub-scales (i.e., physical function, depression, anxiety, ability to participate in social roles/activities, sleep disturbance, fatigue, pain interference, pain intensity).

All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates more of the concept being measured, which scores calculated separately for each of the subscales.

Self-efficacy will be measured using the PROMIS Self-efficacy SF 4a, a 4-item assessment of overall confidence in one's ability to solve problems and cope.

Scores can range from 4-16. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates higher self-efficacy.

This outcome will be measured using the Personal Control Scale, which consists of 15 items and assesses personal control over drinking in the past 90 days (at baseline; past 60 days for post-intervention), and perceived control over one's current drinking. Scores can range from 0-60. Higher scores on this scale indicate participants' perceiving to have a greater degree of personal control over their drinking.

This outcome will be measured using the PROMIS SF Alcohol Use-Negative Consequences 7a, which is a 7-item scale that assesses perceived negative consequences of using alcohol in the past 30 days (e.g. unreliable, social problems, judgement).

Raw scores can range from 7-45. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates a higher degree of perception of negative consequences surrounding alcohol use in the past 30 days.

The PROMIS adult Alcohol Use - Positive Consequences item bank assesses positive personal outcomes of alcohol use over the past 30 days. These items cover physical (e.g., improved sleep, increased sexual desire), mental (e.g., happiness, creativity, positive self-image), and social (e.g., comfort around others, ease in talking to others) consequences of drinking.

Raw scores can range from 7-45. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates a higher degree of perception of positive consequences surrounding alcohol use in the past 30 days.

This outcome will be measured using the Cancer Patient Tobacco Use Questionnaire (core items), which is a 4-item survey that assesses participants' lifetime and current tobacco use. This questionnaire is not scored.

Social support will be measured using the PROMIS Emotional Instrumental Support V2. This consists of 12 items, and assesses perceived emotional support and instrumental support (e.g. help with tasks).

Raw scores can range from 12-60. All PROMIS measures can be converted to T-scores, in which the raw score is rescaled into a standardized score with a mean of 50 of standard deviation of 10. A higher T-score indicates a higher degree of emotional support.

The primary feasibility outcome is enrollment, with a goal of 60% of eligible AYAs approached enrolling in the study. A higher percentage of individuals who enroll in the study indicate the intervention is accessible to the target population.

One of the secondary feasibility outcomes is retention, with a goal of 60% of study participants completing follow-up. A higher percentage of individuals completing follow-up indicates a greater degree of acceptability of the intervention.

One of the secondary feasibility outcomes is intervention adherence, with a goal of 70% of participants completing the program and attending 75% of intervention sessions; with 70% completing the alcohol monitoring. Higher percentages across each of these indicate a greater degree of acceptability of the intervention.

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
Cancer Prevention for Young Rural Adults	NCT05618158	Cancer	4 Corners Rural...	18 Years - 26 Years	Klein Buendel, Inc.
The Oral Microbiome and Upper Aerodigestive Squamous Cell Cancer	NCT03304132	Oral Cancer	Classification ... Classification ...	40 Years - 92 Years	NYU Langone Health
Evaluating an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors	NCT05087875	Cancer Alcohol Use	TRAC: Tracking ... No intervention	18 Years - 39 Years	University of Kentucky
Evaluating an mHealth Intervention for Reducing Alcohol Use Among Rural Adolescent and Young Adult Cancer Survivors	NCT05087875	Cancer Alcohol Use	TRAC: Tracking ... No intervention	18 Years - 39 Years	University of Kentucky
Cancer Prevention for Young Rural Adults	NCT05618158	Cancer	4 Corners Rural...	18 Years - 26 Years	Klein Buendel, Inc.

Spots Global Cancer Trial Database for alcohol use

Every month we try and update this database with for alcohol use 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 alcohol use

Every month we try and update this database with for alcohol use 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 alcohol use 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.