Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Substance Related Disorders

Behaviors and Mental Disorders

Breast Neoplasms

Tobacco Use Disorder

Breast Diseases

Skin Diseases

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

All Drugs and Chemicals

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

This is a randomized, double-blind, placebo-controlled trial comparing the effectiveness and tolerability of varenicline with placebo for smoking cessation in 30 tobacco dependent breast cancer patients.

Pts will receive the standard 12-week dosing regimen consisting of 1 mg po of study drug twice daily for 11 weeks,along with smoking cessation counseling, for 11 weeks with an initial dose titration to full strength during the 1st week as follows: 0.5 mg po once daily for 3 days titrated to 0.5mg po twice daily for 4 days. 154 pills will be supplied for the 12 week tx. In order to compensate for any accidentally dropped or lost pills during the study duration, a total of 175 pills will be given to the patient. Along with smoking cessation counseling, for 11 weeks. Pts will receive their medication from the MSK Pharmacy \& equivalent dosing \& side effect education from our Tobacco Cessation Nurse Practitioner. Tx with the study drug will begin after the initial counseling session. Physicians \& tobacco cessation nurses will be blinded regarding pts' assignment to medication or placebo tx arm. Likewise, pts will not be informed as to which medication condition they have been assigned.

placebo

varenicline

Jamie Ostroff, PhD

Breast cancer patients who smoke, are at greater risk for treatment complications. The purpose of this study is to see if the researchers can find ways to help patients who have breast cancer quit smoking. They will compare two ways to help people quit smoking. Some patients will receive varenicline, a prescription medicine also known as Chantix,®. Other patients will receive a placebo drug. A placebo is an inactive substance that contains no medicine. All patients will receive smoking cessation counseling provided by our tobacco treatment specialists. They hope that what the researchers learn from this study will help us improve our smoking cessation treatment program for breast cancer patients.

Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)

Treatment of Tobacco Dependence in Breast Cancer Patients: A Randomized Trial of Varenicline (Chantix)

To conduct a double-blind, randomized clinical trial to obtain pilot data on the the effectiveness of Intervention (varenicline and behavioral smoking cessation counseling) and Control (placebo and behavioral smoking cessation counseling) with regard to tobacco (smoking) cessation outcomes (point abstinence, continuous abstinence) in tobaccodependent breast cancer patients.

To describe the association between baseline factors (i.e., demographic, smoking history and psychosocial) and poor cessation treatment response (i.e., persistent smoking, post-surgical smoking relapse

Adherence to study medication will be assessed by summarizing the medication logs. Tolerability will be assessed by percent of patients who discontinue study medication due to side effects. Using CTCAE 4.0

among tobacco dependent breast cancer patients. We will primarily use descriptive statistics to summarize the rates of surgical complications among tobacco dependent breast cancer patients, as indicated by the prevalence of surgical complications (i.e., occurrence of infection, skin flap necrosis, reconstructive flap failure, seroma, and hematoma) documented in the patient's medical record.

Pfizer

Memorial Sloan Kettering Cancer Center

Participants will receive up to a total of 3 iMD sessions prior to their completion of radiation therapy; each session will take about 10-15 minutes and includes: 1) computerized assessments that will be delivered on the screen via text with accompanying audio and participants will respond directly on the tablet 2) tailored videos that deliver messages specific to patient's responses to selected assessment questions and 3) a summary printout

Participants will complete questionnaires and receive a handout containing tobacco cessation resources.

Interactive Mobile Doctor (iMD)

Janice Tsoh

Edgar Yu

Janice Tsoh, PhD

The proposed pilot study aims to develop and test a patient video educational tool, an interactive Mobile Doctor (iMD), that can be integrated in radiation oncology setting to effectively engage cancer patients receiving treatment at University of California, San Francisco (UCSF) to facilitate smoking cessation and maintaining smoking abstinence in the context of their radiation treatment.

This study is the first to address tobacco use among can patients receiving radiation therapy that targets both tobacco cessation (current users) and maintaining abstinence (former users who have recently quit).

The interactive Mobile Doctor (iMD) is an interactive video educational program that delivers tailored messages in response to participants' input, generates a summary report providing tobacco use status and cessation resources and solicits participants' interest in receiving referral or information to tobacco cessation resources.

PRIMARY OBJECTIVE:

I. To assess the feasibility and acceptability of the interactive Mobile Doctor (iMD), an interactive patient education tool, utilizing patient-centered and interactive technology approaches to target cancer patients who report using tobacco within the past 12 months and who are receiving or planning to receive radiation therapy for cancer.

SECONDARY OBJECTIVES:

I. To assess preliminary efficacy of iMD on tobacco abstinence when compared to the control (assessment + resource information only).

II. To estimate impacts of iMD on referral requests.

Participants will be randomized to either the iMD or Control Group in a 1:1 ratio, stratified by tobacco use status within past 30 days (current vs former tobacco users), to the iMD intervention or the control group

iMD Intervention Participants: Participants receive up to a total of 3 iMD sessions prior to their completion of radiation therapy (RT). The iMD session will take about 10-15 minutes and will include: 1) computerized assessments(tobacco use in past 12 months and in past 30 days; types of tobacco used, time to first cigarette or tobacco use, cigarettes used per day on a typical day of use, readiness for quitting, and concerns about quitting smoking) that will be delivered on the screen via text with accompanying audio and participants will respond directly on the tablet 2) tailored videos that deliver messages specific to patient's responses to selected assessment questions, including addressing misconceptions of being too late to quit smoking after cancer diagnosis, which could be a barrier for quitting smoking, or tobacco-free is not necessary after completion of RT; and 3) a summary printout, the iMD Summary Reported generated at the end of each iMD session will provide a summary of a participant's RT completion status or anticipated completion date, tobacco use status, plans for quitting or commitment to abstinence, key messages addressing participants' concerns and uniform resource locator (URL)s of the videos watched, California Smokers' Helpline website and telephone numbers, and interest to be contacted by a tobacco treatment specialist or in receiving for tobacco use, referred to tobacco treatment resources.

Control Group Participants: Participants will undergo the assessment questions. Instead of viewing and participating in the interactive video education about tobacco cessation or tobacco-free living, will participants receive a handout containing tobacco cessation resources.

Participants will be followed up for 3 month after their first visit.

Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients

The proportion of participants who consent to enroll from the total number who are approached for eligibility will be reported.

The proportion of participants assigned to iMD intervention who have a recorded response to the question on referral to a smoking cessation treatment service/ resource will be reported.

The proportion of participants enrolled in the iMD arm who complete at least 2 or more of the iMD sessions will be reported.

The perceived helpfulness of the iMD program will be measured using a 5-point likert scale a a response to the question provided to the participants who are assigned to the iMD arm which rates the helpfulness of the intervention as 1='Somewhat helpful" to 5="Very helpful

Proportions of participants with self-report + biochemically verified tobacco abstinence (salivary cotinine or exhaled CO)

The investigators will estimate impacts of iMD on yield referral requests (when participants respond "Yes" to be referred for smoking cessation related services) for participants assigned to the iMD program

Tobacco Related Disease Research Program

University of California, San Francisco

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Central Nervous System Stimulants

Nicotine

Participants will receive a virtual counselor intervention for smoking cessation, be offered the opportunity to utilize nicotine replacement therapies, participate in shared decision-making around lung cancer screening, and be supported by a community health worker. Participants will be followed for a total of 3 months. Assessments will be conducted at baseline, 1 month, and 3 months.

A two-module tobacco cessation intervention that involves interaction with a virtual counselor and includes instruction about addiction and the use of pharmacotherapy for cessation. Each module takes approximately 20 minutes to complete.

C-Raven Virtual Tobacco Cessation Counseling

Participants will be offered a 12-week supply of nicotine patches and either nicotine gum or lozenges.

Nicotine Replacement Product

A community health worker will meet with each participant throughout the study period to teach appropriate NRT usage, discuss barriers/facilitators to NRT use and cessation, conduct shared decision-making about lung cancer screening, and provide health system navigation when needed.

Community Health Worker

Eligible participants will be referred to their primary care physician or existing specialist to complete lung cancer screening.

Lung Cancer Screening

Jeanne Clark, MD

To inform a future randomized trial of a virtual counselor led computer delivered intervention for tobacco cessation augmented with community health worker (CHW) support and navigation to lung cancer screening in low-income housing units in Baltimore, the investigators propose to collect data on intervention acceptability and feasibility among individuals in public housing as well as feedback on use of shared decision making when referring for low-dose chest CT (LDCT).

The investigators will conduct a feasibility pilot study of a virtual counselor plus community health worker intervention. With a sample of participants from public housing units (N=15), the investigators will collect data on feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, 1 month and 3 months. At the end of three months, the investigators will conduct follow up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on this information, the investigators will make iterative improvements to the combined intervention.

In anticipation of a future two-arm type 1 hybrid effectiveness-implementation randomized controlled trial comparing a virtual counselor-led computer delivered intervention (VCTC) augmented with CHW support in low-income housing units in Baltimore City. This pilot study will generate preliminary data for a larger study. The investigators will conduct a feasibility pilot study of the entire VCTC and CHW intervention with a sample of participants (N=15) to collect data on the feasibility of recruitment, intervention engagement and completion, and short-term smoking cessation outcomes. Individuals will be assessed at baseline, one month, and three months. At the end of three months, the investigators will conduct follow-up interviews with a subset of pilot participants to collect qualitative data on intervention acceptability. Based on the information collected in these efforts, the investigators will make iterative improvements to the existing intervention, aligned with user-experience design procedures.

Participants will be recruited through flyers posted in and around the housing units and distributed to tenants by housing unit staff. Flyers will describe the study and contain a study phone number to call. Information may also be distributed by study staff during non-study-related health and wellness activities conducted at the sites. At initial contact, a study staff member will discuss the study purpose and determine eligibility. If eligible, the staff member will proceed to discuss requirements, review risks and benefits, and obtain informed consent from interested participants.

Consent process: After confirming eligibility with screening questions via phone, potential participants will be offered the option of reviewing the study information and consent form over a Zoom video conference. Regardless of whether the participants choose to review this information in advance, all potential participants will complete the consent process and sign the consent form at the beginning of the first in-person visit, which will be conducted on-site at the participants housing community.

Baseline Assessment: This will occur on the same day as the in-person portion of the consent process. Initial evaluation will comprise the research assessments detailed in Table 1, including demographics, a clinical history, a tobacco use history, and a number of tobacco-related measures. Assessments will be self-administered via tablet computer.

Intervention:

Computer-Delivered Intervention (CDI) Session 1: Following the baseline assessment, participants will receive computer-delivered counseling via a study-provided iPad delivered in a private room. VCTC consists of 1) a menu-driven, web-based intervention that is delivered by a virtual counselor. The intervention takes 20 minutes to complete. At the conclusion of session 1, the participant will be offered nicotine patches provided by the study (1 month supply, remainder given at follow-up visits). The initial dosing of the nicotine patches will be determined based on cigarettes consumed per day (\>10: 21mg patch, 5-10: 14mg patch, \<5: 7mg patch). If there is any question regarding eligibility or appropriate dosing, the CHW will consult with a study physician. With the CHW, the participant will learn correct application, and will monitor the participants nicotine replacement therapy (NRT) experience in discussion with the CHW.

Computer-Delivered Intervention (CDI) Session 2: Session 2, delivered approximately one week later, focuses on the cycle of addiction and use of pharmacotherapy (e.g., NRT, bupropion, varenicline). This intervention also takes about 20 minutes to complete. At the conclusion of session 2, the participant will be offered nicotine gum or lozenges provided by the study (1 month supply, remainder given at follow-up visits). This session also includes an in-session experience of using NRT gum or lozenge, with CHW guidance to ensure correct use.

Community Health Workers (CHWs): A CHW will meet with each participant for both Sessions 1 and 2 and will do the following: 1) Teach appropriate NRT use technique as above, 2) Follow up with patients remotely via phone or video conference whenever possible, up to twice weekly for 12 weeks, to discuss barriers/facilitators to maintenance of NRT use and tobacco cessation; 3) Review the modified lung cancer shared decision-making guide from Phase 1 and provide linkage to lung cancer screening if the participant is eligible and interested, including linkage to insurance enrollment assistance, if needed; 4) For individuals requiring follow up for positive findings on lung CT, work with participants to navigate the process; 5) Link interested participants to the QuitLine; 6) At the end of the study, link to medical providers for additional tobacco cessation therapy if participant interested (e.g., varenicline, bupropion).

Linkage to Lung Cancer Screening: Participants eligible for and interested in CT Lung cancer screening (age ≥50, ≥20 pack year smoking history) will be referred to the participants primary care physician (PCP) or existing specialist for further discussion and ordering. The CTs are optional and will not be provided as part of the research study. The CHW will assist with linking patients without a PCP or existing specialist with resources to establish care. For participants who choose to proceed with screening, the investigators will request the results of the CT scan to track completion and general result category (Normal/Normal with Minor Findings/Abnormal Needing Short-Term Follow-Up/Abnormal Needing Immediate Follow-Up).

Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community

Feasibility, Acceptability, and Piloting of a Virtual Counselor Tobacco Cessation Intervention With Community Health Worker Linkage to Lung Cancer Screening

Acceptability and Feasibility will be assessed through quantitative and qualitative data on factors including (e.g., number of participant engagement, number of barriers,completion of modules, number of sessions with CHW).

The Readiness Ruler is a brief measure of motivation, which prompts patients with a 10-point visual analog scale on which they rate readiness, with a score of 0 reflecting "not ready," and a score of 10 reflecting "ready."

Number of participants that start using NRTs during the study period

Number of participants that continue to use NRTs at 1 month and 3 months

Number of participants that attempt to quit, and how many quit attempts each makes during the study period

Number of participants that have maintained cessation for at least one week prior to the assessments at 1 month and 3 months

Number of participants that choose to utilize Quit Line services

Overall satisfaction with the intervention. This will be measured with a 19 item questionnaire which uses a 5 item Likert Scale for each question. Answers of "agree" and "strongly agree" will be evaluated across the intervention components,

Maryland Cigarette Restitution Fund

Johns Hopkins University

Herbal and Botanical

Kava

Participants on this arm will take one kava capsule (each capsule contains 75 mg of kavalactones) orally three times daily for 28 days.

Participants on this arm will take one placebo capsule orally three times daily for 28 days.

Placebo

Melissa Malham

Nicole Davila

Ramzi Salloum, PhD

Tobacco use is the leading cause of many preventable diseases, particularly lung cancer. Based on the national cancer data in 2020, Florida has the highest lung cancer incidence (18,150 cases) with the most deaths (10,580 deaths) among all the states in the United States. Unfortunately, around 16% of adults in Florida continue to smoke cigarettes due to its addictive nature and the limited success of current cessation strategies. Therefore, there is an unmet and urgent need for novel interventions to improve the success of tobacco cessation. If such an intervention can reduce tobacco-associated lung carcinogenesis, that will be more desirable. The ultimate goal of this study is to develop a safe and effective kava-based intervention to enable tobacco cessation and reduce lung cancer risk, which will improve the health of Floridians.

This study will evaluate the compliance with a daily kava regimen among active smokers who have no intention to quit smoking. This study will also investigate whether kava use can reduce tobacco use and dependence, as well as tobacco-associated lung carcinogenesis.

Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava

Evaluate subject compliance with the kava intervention, as measured by participant reported number of missed doses

Evaluate subject compliance with the kava intervention, as measured by detection of dihydromethysticin in participant urine

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by participant reported number of cigarettes smoked

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Fagerström Test for Nicotine Dependence (FTND)

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Modified Cigarette Evaluation Questionnaire (mCEQ)

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by the Brief Questionnaire on Smoking Urges (QSU-Brief)

Examine whether kava has the potential to help facilitate tobacco cessation, as measured by urinary total nicotine equivalents

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tobacco Dependence in Breast Cancer Patients Trial of Varenicline (Chantix)	NCT01532232	Breast Cancer Tobacco Depende...	placebo varenicline	18 Years -	Memorial Sloan Kettering Cancer Center
Interactive Mobile Doctor (iMD) to Promote Tobacco Cessation Among Cancer Patients	NCT05021185	Tobacco Depende... Tobacco Use Ces... Cancer	Interactive Mob...	18 Years -	University of California, San Francisco
Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community	NCT06289192	Tobacco Depende...	C-Raven Virtual... Nicotine Replac... Community Healt... Lung Cancer Scr...	50 Years -	Johns Hopkins University
Reducing Tobacco-associated Lung Cancer Risk: A Randomized Clinical Trial of AB-free Kava	NCT05081882	Smoking	Kava Placebo	21 Years - 99 Years	University of Florida
Testing C-Raven, a Virtual Tobacco Cessation Intervention, in the Community	NCT06289192	Tobacco Depende...	C-Raven Virtual... Nicotine Replac... Community Healt... Lung Cancer Scr...	50 Years -	Johns Hopkins University

Spots Global Cancer Trial Database for tobacco dependence