Participants will complete a baseline survey, 11 weekly surveys, and a follow-up survey at 12 weeks

There is no intervention or exposure for this study

There is no intervention for this study

The objectives of this study are to pilot test a protocol of weekly assessments of motivation to quit and other relevant constructs combined with information about how to enroll in cessation programs, which will allow initial quantification of motivation to quit during cancer treatment and develop hypotheses about the impact of motivation on the decision to enroll in services.

mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients

Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients Pilot Study

Assessed using self-report on the weekly and 12-week survey

Assessed using self-report (PHQ-4) on the weekly and 12-week survey

University of Virginia

Research Assistant Professor of Public Health Sciences

Behaviors and Mental Disorders

All Conditions

Behavior, Addictive

Compulsive Behavior

Impulsive Behavior

The program consists of five 50-minutes sessions conducted in person as scheduled during weekly class meetings. Educators will conduct workshops with PowerPoint presentations and worksheets dedicated to in-class activities.

educational intervention

Łukasz Moskal, MD

Konrad Reszka, MD

Urszula Staszek-Szewczyk, MD, PhD

Jagoda Łaba, MD

Krzysztof Szewczyk, MD, PhD

Smoking Prevention Program is a pilot exploratory study with a standardized curriculum based on the Tobacco Prevention Toolkit from Stanford University and translated into Polish by the members of Students Scientific Association of Oncology at Wroclaw Medical University. The program will assess the effectiveness of a school-based smoking prevention curricula keeping children as never smokers and test the feasibility of engaging medical students and teachers in implementing and evaluating a validated program on smoking prevention within the Polish School System. The research protocols, methods and data collection instruments of a standardized classroom based valid tobacco prevention program from Stanford University will be used for the study. The smoking prevention program is centred on drug resistance, personal self-management and increasing social skills. The program increases knowledge and uses coaching and practice to provide students with the skills to resist social pressures around cigarette use. The secondary outcome of this study is to determine the change in attitudes by Polish Medical Student regarding Cancer Prevention Research. During Smoking Prevention Program workshops, the 5-Session Curriculum for primary schools will be translated, applied and evaluated for polish students.

This community-based pilot will engage medical students, the local school district and the local health authority. The Educational program meets the requirements set by Centers for Disease Control and Prevention (CDC) in Guidelines for School Health Programs to Prevent Tobacco Use and Addiction. Following parental consent, the program will be implemented with all 7th and 8th grade students (children age 12-15 years) from the Elementary School in Tyniec Mały. This project is supported by the Head of Lower Silesian Oncology Center, the Head of Department of Oncology of Wroclaw Medical University, the Health and Social Affairs Department of City of Wroclaw and under the patronage of the Lower Silesia Governor's Office, the Polish Society of Oncology, the Polish Society of Public Health, the Lower Silesian Department of Polish Society of Cardiology and the European Association for Cancer Education (EACE).

Smoking Prevention Program is funded by the READS Grant Program from the American Association for Cancer Education (AACE).

Smoking Prevention Program in Poland

Youth Smoking Prevention Program in Poland

Change in smoking intention among elementary school students after program completion (score based on survey results).

Change in knowledge about adverse effects of smoking after program completion (score based on survey results).

Stanford Reach Lab - Tobacco Prevention Toolkit

American Association for Cancer Education

Wroclaw Medical University

Principal Investigator

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants who list "Patient Gateway" as the preferred mode of contact in the electronic health record (EHR) system. Patient Gateway is an online patient portal that gives patients access to securely message their Mass General Brigham provider, request routine appointments, prescriptions and referral authorizations as well as view test results that were processed at a Mass General Brigham facility. Participants will receive the digital educational lung cancer screening video via their patient gateway account.

Participants who list "Text" as the preferred mode of contact in the electronic health record (EHR) system. Participants will receive the digital educational lung cancer screening video via a text message sent directly to their cell phone.

Participants who list "Email" as the preferred mode of contact in the electronic health record (EHR) system. Participants will receive the digital educational lung cancer screening video directly to the email they have listed.

An educational video on lung cancer screening tailored to Hispanic current and former smokers.

Educational Lung Cancer Screening (LCS) Video

Efren Flores, MD

The goal of this clinical trial is to promote lung cancer screening (LCS) uptake among Hispanic current and former smokers. The main questions it aims to answer are:

* What barriers do current and former Hispanic smokers face in the identification and documentation of their smoking status?
* How can digital delivery of an educational video promote LCS uptake among current and former Hispanic smokers?

Participants will receive an educational video about lung cancer screening and complete brief, self-reported surveys afterwards.

Lung cancer remains the leading cause of cancer-specific mortality in the US, and Hispanics experience worse lung cancer outcomes and die at higher rates due to advanced stage at presentation. Lung cancer screening (LCS) can save many lives through early lung cancer detection among Hispanic current and former smokers.

Still, without increasing efforts to improve smoking status disclosure and documentation and tailored interventions to promote LCS uptake among Hispanic current and former smokers, this underserved population will continue to demonstrate disparities in lung cancer survival. Based on prior research experience, Dr. Flores has adapted the NIMHD research framework by incorporating elements from Ford's evidence-based theoretical model to guide the following proposed study aims:

1) To elucidate barriers and facilitators to consistent identification and documentation of smoking status to promote LCS uptake among Hispanic current and former smokers; 2) To assess feasibility, acceptability, and reach of the digital delivery of an educational video to promote LCS uptake among Hispanic current and former smokers; 3) To explore the effect of the digital delivery of the educational video to increase interest, intent, and scheduling of LCS uptake among Hispanic current and former smokers.

Impact: The successful completion of this research will serve as a foundation for developing novel interventions to overcome disparities and advance equity in lung cancer outcomes among Hispanics and other vulnerable populations.

Health Opportunities and Promoters of Equitable Screening for Lung Cancer

Health Opportunities and Promoters of Equitable Screening for Lung Cancer (HOPES for Lung Cancer)

Identify salient participant characteristics obtained from the EHR (e.g., smoking status) among those that interacted with the digital delivery modality.

Investigate attributes of the intervention to guide future research and development to create such an intervention (for future trials)

Reach is defined as \>20% of enrolled participants interacting with the digital delivery of the LCS educational video (i.e., partial or complete review of the LCS educational video).

Overall proportion of participants that click on the embedded link to the successfully digitally delivered LCS educational videos

Duration of viewing the LCS video (i.e., partial or complete)

Overall proportion of survey completion by participants.

National Cancer Institute (NCI)

Massachusetts General Hospital

All Drugs and Chemicals

Nicotine

The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening

The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks and an educational brochure about lung cancer screening

The ESCAPE intervention consists of five components:1) behavioral counseling, 2) the use of NRT, 3) digital SNC 4) decision aid about LDCT screening, and 5) a letter and educational materials sent to the primary care provider.

Escape

Participants in the standard care arm (brief advice and referral to quit line), will be referred to the MA Quitline which provides free NRT by the study team and will receive an educational brochure related to lung cancer screening.

Standard Care

Mary E. Cooley, PhD

This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening.

In this research study involves Studying the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program compared to usual care.

The ESCAPE program was developed help women with HIV quit smoking. Women in the ESCAPE program quit smoking and stayed quit for longer (up to 3 months). For this study, investigators have added a lung screening to the ESCAPE program and want to test if this will improve lung health through increasing quit rates and lung screening.

.

* This is a research study, is testing a program to improve lung health through smoking cessation and providing education around lung screening. The research study procedures include: screening for eligibility and study interventions including participation in counseling and completion of questionnaires by e-mail, phone or in-person.
* This research study involves participating in either the Enhanced Smoking Cessation Approaches to Promote Empowerment (ESCAPE) program or the usual care. Participants will be randomized into one of two groups:

  * ESCAPE: The ESCAPE program provides 8 counseling sessions over the phone, provides nicotine replacement therapy at no cost, and education about lung screening
  * Usual Care: The usual care program will include 1 counseling session, nicotine replacement therapy at no cost referral and enrollment in quitworks
* Participants will be in this research study for up to 6-months.
* It is expected that about 250 people will take part in this research study.

Digitally Enhanced Smoking Cessation for High Risk Smokers

A Digitally-enhanced Smoking Cessation Intervention for High-risk Smokers: Phase II

The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

biochemical verification of smoking status will be done and the %7-day point prevalence abstinence will be compared between two groups with exact binomial test,

self-report number of cigarettes will be compared with exact Poisson test.

(stage of low-dose computed tomography \[LDCT\] screening adoption) Lung Cancer Screening Behaviors\[20\] will be measured with a questionnaire based on the Precaution Adoption Process Model. This model has seven stages of adoption which includes; stage 1=no awareness of lung cancer screening, stage 2=not engaged with lung cancer screening, stage 3=deciding about action, stage 4= decide not to screen, stage 5=decided to act, stage 6-=acting, and stage 7=maintenance. stage of change will be compared between two groups with exact binomial test,

The evaluation of the storytelling narrative communication at 1 and 3 months will be defined as follows:1) \> 80% receipt and completion rate of watching the SNC digitalized videos.

Descriptive statistics (estimate and 95% CI) will be used to report completion rate.

defined as \> 80% of the group perceive the film as just right in length in addition to favorable comments, the Narrative Engagement Scale scores are ≥ to the established means ). Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.

\> 80% of the group comments indicate that the film would have value to others and the Narrative Engagement Scale scores are ≥ to the established means. Descriptive statistics (estimate and 95% CI) will be used to report percentage and one-sample t-test will be used to compare Narrative Engagement Scale scores to the established means.

The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months \[37\] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with 7 indicating greater engagement.

The ratings of SNC videos will be evaluated using the Narrative Engagement Scale that will be administered at 1 and 3 months \[37\] The scale is a paper and pencil questionnaire developed to measure the extent to which the viewer of narratives in a variety of forms (film, TV etc.) becomes engaged, transported, or immersed in the narrative and the potential of the narrative to affect change in story-related attitudes and beliefs. The scale scores range from 1-7 with higher scores indicating greater engagement.

We will construct three PRS. The first will be based on the lead single nucleotide polymorphisms (SNPs) from 183 independent genetic loci associated at genome-wide significance (p\<5x10-8) with ever smoking status in adults from the UK Biobank and the Tobacco and Alcohol Genetic Consortium. The risk will be calculated as the weighted sum of each genetic variant, under an additive genetic model, counting the number of copies of the risk increasing allele. The weights will be proportional to the estimated effect size of each SNP. The second risk score will be constructed from a larger set of SNPs (\~1 million) from the same GWAS using LDPred that allows for the construction of more powerful PRSs for specific racial groups using linkage disequilibrium information from large genetic reference panels. Finally, we will also construct a PRS based on the GWAS results for the largest available study specifically for nicotine dependence using the LDPred approach.

A semi-structured interview will be conducted with participants. Topics for the interview guide include; 1) perceptions of genomic evaluation, 2) experiences for providing risk information, 3) preferences for receiving risk information, 4) experiences with the study interventions, 5) suggestions for program improvements.

American Association for Cancer Research

Dana-Farber Cancer Institute

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Recurrence

Urinary Bladder Neoplasms

Disease Progression

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Disease Attributes

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Motivational Interviewing with WhatsApp video call The individuals in the intervention group will be given a smoking cessation education and motivational interview with a WhatsApp video call for 3 months. The motivational interview will be applied every two weeks, 6 times in total. Self-efficacy scale and smoking behavior scale will be administered again at 3, 6 and 12 months after the intervention. tumor recurrence and progression will be checked by cystoscopy at 3rd and 12th months

the control group received the routine care/education provided in the hospital. Self-efficacy scale and smoking behavior scale will be administered again at 3, 6 and 12 months after the routin hospital care. Both intervention and control groups' tumor recurrence and progression will be checked by cystoscopy at the 3rd and 12th months

The intervention group will be given a motivational interview with a WhatsApp video call for 3 months. Motivational interviews will be applied every two weeks, 6 times in total.

Behavioral: Motivational Interviewing with WhatsApp video call

İREM NUR ÖZDEMİR, PhD, RN.

İrem Nur Özdemir, PhD, RN

This study will be carried out to examine the effect of telephone-assisted smoking cessation program on self-efficacy, smoking behavior, tumor recurrence and progression in patients with non-muscle invasive bladder cancer.

This study will be conducted to examine the effect of a telephone-assisted smoking cessation program (3 months) on self-efficacy, smoking behavior, tumor recurrence and progression for chronic disease management in patients diagnosed with non-muscle invasive bladder cancer. After 3 months of motivational interviewing was applied to the experimental group, the scales will be applied in the 3rd, 6th and 12th months. The cystoscopy will be performed at 3 and 12 months for tumor recurrence and progression

This study is a parallel group randomized controlled study.

The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

The Effect of Telephone-Assisted Smoking Cessation Program on Self-Efficacy, Smoking Behavior, Tumor Recurrence and Progression in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer

The scale is rated on a 10-point scale ranging from "not at all sure" to "very sure". The score obtained from the scale is the average of 6 items, and high scores indicate high self-efficacy. If more than one answer is given to an item and the items follow each other, the lower score is included in the calculation. In order to calculate the scale, at least 4 items must be answered. The Croncbach's alpha coefficient was 0.91 and the mean of the original scale was 5.17 ± 2.22. Turkish validity and reliability was done by İncirkuş and Nahcivan (2020). The Cronbach's alpha coefficient of the scale was found to be 0.90.

The Turkish validity and reliability of the scale was done by Sancar. The scale was created as a scale with 11 questions as a result of the Turkish adaptation study, and each question is scored from 0 to 4 with a 5-option scoring system. Behavioral addiction score below 12 is mild, 12 and 22 moderate, 23-33 strong, 33 above very strong behavioral addiction score has been suggested. The scale is a valid and reliable scale that can be used to determine the behavioral aspect of smoking addiction of smokers, both in its one-dimensional and 2-dimensional form. The Croncbach alpha coefficient was found to be 0.82. This value indicates that the scale is quite reliable in terms of internal consistency. The "Conditioning and Significance" sub-dimension of the scale consists of 5 items and the Cronbach's alpha coefficient is 0.762. The "Handling and Emotions" sub-dimension consists of 6 items and the Cronbach's alpha coefficient is 0.735.

Tumor recurrence will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Progression will be examined by cystoscopy at the 3rd and 12th months after the intervention.

Bakirkoy Dr. Sadi Konuk Research and Training Hospital

Wounds and Injuries

Fractures, Stress

Fractures, Bone

Kendra Rowe

Massey CPC Team

Chanita Hughes Halbert, PhD

Trista Beard, EdD

Robert Winn, MD

The purpose of this study is to examine racial differences in smoking behaviors and stress responses between African American and white male smokers.

Cigarette smoking is a leading cause of morbidity and mortality from lung cancer among adults in the US. Stress relief and smoking cessation is the best preventive strategy for reducing lung cancer risk and addressing racial disparities in outcomes. Despite this, racial differences are found among those that make quit attempts. Stress has been found to be related to smoking initiation, maintenance, and relapse. Yet, differences in stress responses have not been examined between African American and white smokers. Therefore, this study will examine racial differences in stress responses and smoking behaviors between African American and white male smokers

Saliva will be conducted for analyzing biomarkers of stress (i.e. cortisol, alpha-amylase), and biomarkers related to smoking (i.e. cotinine)

Urine will be collected to determine the presence of illicit substances as an indicator of exclusion/inclusion into the study.

Patients that provide consent will have additional saliva and urine collected and stored in a centralized biorepository for future research

Translational Research Center in Lung Cancer Disparities (TRACER) Project 2

Biological Pathways in Stress Reactivity and Nicotine Addiction Among African American and White Smokers

Examine racial differences in acute stress responses using a validated psychological stress challenge called the Trier Social Stress Test (TSST)

Examine racial differences in daily diurnal cortisol slopes to evaluate hypothalamic-pituitary-adrenal-axis dysregulation and acute stress

Patients will be administered a survey using validated measures to examine socioeconomic, structural, and psychosocial stressors that impact daily stress and smoking behaviors

City of Hope Medical Center

Medical University of South Carolina

Virginia Commonwealth University

Substance Related Disorders

Tobacco Use Disorder

Carcinogenesis

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

Neoplastic Processes

15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

This study aims to assess the feasibility, acceptability, and the potential harm reduction of switching to potentially lower risk, oral nicotine pouches in adult smokers. Part One of this study aims to assess the interest of current smokers in switching to an e-cigarette device (i.e. JUUL) compared to alternative non-combustible tobacco products (i.e. smokeless tobacco/snus) and/or medicinal nicotine via survey. Part Two will consist of a pilot study of 30 non-treatment seeking adult smokers to investigate within-person changes in smoking behavior as a result of switching to different concentrations of oral nicotine pouch products (i.e. ZYN, 3mg and 6mg nicotine concentration). Additionally, by measuring bio-markers of tobacco exposure from baseline, this will allow the study to assess the potential for harm reduction in switching from cigarettes to oral nicotine pouches.

30 current non-treatment seeking adult smokers will be randomized to either the 3mg or 6mg nicotine concentration ZYN condition.

Switching to Potential Reduced Exposure Products in Adult Smokers

Switching to a Non-tobacco-based Oral Nicotine Product Among Adult Cigarette Smokers: Exploring the Roles of Product Characteristics and User History

The investigators will compare whether smoking behavior varies by the 3mg and 6mg nicotine concentrations as measure by the standardized Timeline Followback Interview.

To investigate whether switching behavior varies by the 3mg and 6mg nicotine concentrations

The investigators will compare whether the smoke free days vary by the 3mg and 6mg nicotine concentrations

Participants will provide repeated lab samples for biomarker assessments. Urine samples obtained will be compared at baseline and week 4 for differences by group and by time.

To evaluate the acceptability of switching, participants will also be asked how likely it is that they will continue to use ZYN oral nicotine patches for cigarette substitution compared to cigarettes on a question designed for this trial.

Yale University

15 participants will be randomly assigned to receive ZYN Pouches with 3mg nicotine concentration.

ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

3mg Nicotine Concentration

15 participants will be randomly assigned to receive ZYN Pouches with 6mg nicotine concentration.

ZYN: 30 current non-treatment seeking adult smokers will be switched from smoking cigarettes to ZYN oral nicotine pouches containing either 3mg or 6mg concentration nicotine salts.

6mg Nicotine Concentration

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race Customized

Race/Ethnicity, Customized

United States

Region of Enrollment

This is binary count of yes/no responses to whether or not participants smoke their first cigarette within 30 minutes of waking in the morning.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
mMe: Motivational Monitoring to Enhance Smoking Cessation Among Cancer Patients	NCT05370859	Smoking Behavio... Cancer Motivation	There is no int...	18 Years -	University of Virginia
Smoking Prevention Program in Poland	NCT05488743	Smoking Smoking Behavio... Smoking (Tobacc... E-cigarette Use Vaping	educational int...	12 Years - 15 Years	Wroclaw Medical University
Health Opportunities and Promoters of Equitable Screening for Lung Cancer	NCT05784922	Lung Cancer Smoking Behavio... Diagnosis	Educational Lun...	50 Years - 80 Years	Massachusetts General Hospital
Digitally Enhanced Smoking Cessation for High Risk Smokers	NCT04691297	Smoking Smoking Cessati... Lung Cancer Scr... Smoking, Tobacc... Smoking Behavio...	Escape Standard Care	55 Years - 77 Years	Dana-Farber Cancer Institute
The Effect of Telephone-Assisted Smoking Cessation Program in Patients Diagnosed With Non-Muscle Invasive Bladder Cancer	NCT05704231	Non-Muscle Inva... Self Efficacy Smoking Behavio... Tumor Recurrenc... Progression, Di...	Behavioral: Mot...	21 Years -	Bakirkoy Dr. Sadi Konuk Research and Training Hospital
Smoking Prevention Program in Poland	NCT05488743	Smoking Smoking Behavio... Smoking (Tobacc... E-cigarette Use Vaping	educational int...	12 Years - 15 Years	Wroclaw Medical University
Translational Research Center in Lung Cancer Disparities (TRACER) Project 2	NCT05490251	Smoking Smoking Behavio... Smoking Cessati... Stress Reaction		18 Years - 75 Years	Virginia Commonwealth University
Health Opportunities and Promoters of Equitable Screening for Lung Cancer	NCT05784922	Lung Cancer Smoking Behavio... Diagnosis	Educational Lun...	50 Years - 80 Years	Massachusetts General Hospital
Switching to Potential Reduced Exposure Products in Adult Smokers	NCT04250727	Tobacco Use Dis... Oral Nicotine P... Smoking Behavio... Harm Reduction Toxic Effect of... Carcinogenesis	ZYN	21 Years - 77 Years	Yale University

Spots Global Cancer Trial Database for smoking behaviors