Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Skin and Connective Tissue Diseases

Lung Neoplasms

Carcinoma

Prostatic Neoplasms

Breast Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Breast Diseases

Skin Diseases

MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training.

PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions.

PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.

Undergo motivational interviewing training

Communication Skills Training

Medical Chart Review

Questionnaire Administration

Attend phone or in-person motivational interviewing coaching sessions

Tobacco Cessation Counseling

John Holland

This pilot clinical trial studies how well provider training works in increasing patient tobacco cessation counseling and referrals for patients with cancer undergoing radiation therapy. Health care provider training in motivational interviewing techniques and utilizing tobacco cessation resources may help doctors understand how health care providers can effectively increase their confidence in talking to patients about tobacco cessation counseling.

PRIMARY OBJECTIVES:

I. To determine if training providers on tobacco cessation resources increases the frequency of counseling and referrals at initial and follow-up consultations for cancer patients who use tobacco and are scheduled to receive radiation at Oregon Health and Science University (OHSU).

SECONDARY OBJECTIVES:

I. Increase provider frequency of tobacco use quantification and type. II. Increase frequency of provider assessment of tobacco cessation readiness in current users.

III. Increase frequency and types of tobacco cessation resources and medicines offered and utilized.

IV. Increase frequency and type of follow-up planned if referred to cessation resource.

OUTLINE:

MEDICAL CHART REVIEW: Medical charts from patients with diagnoses of head and neck cancer, lung cancer, prostate cancer, or breast cancer are reviewed at months 1-12 to determine the frequency of tobacco assessments and documentation of discussions with patients regarding tobacco use and utilization of cessation resources as before and after the proposed training.

PROVIDER TRAINING: Providers undergo training to use patient coaching such as the 5A's (Ask, Advise, Assess, Assist, and Arrange), to conduct regular tobacco intake assessment using motivational interviewing techniques. Providers also undergo training to use public/community tobacco cessation resources for patients ready to quit within six weeks, and have access to pharmacy residents for ad-hoc prescribing questions.

PATIENT COACHING: Patients attend 4 phone or in-person motivational interviewing coaching sessions over 30-45 minutes for 6-8 weeks or longer as needed.

Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy

Integrating Tobacco Cessation Coaching Sessions Into Radiation Medicine Treatment: A Pilot Study

Will be compared between the cohort of pre and post intervention. Will be summarized using descriptive statistics and compared using chi-square test by tumor type.

Will be summarized using descriptive statistics and compared using chi-square test by tumor type.

Will be tested using a chi-squared test. If any expected cell count in the contingency table is lower than 5, we will instead use Fisher's exact test.

Will be summarized using descriptive statistics and compared using chi-square test by tumor type. Will be tested using Z tests of proportion.

Oregon Health and Science University

OHSU Knight Cancer Institute

Associate Professor

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

Best Practice

Nicotine Patch

Quality-of-Life Assessment

Robert J. Volk

Robert J Volk

This trial studies how well a centralized care strategy works in improving the quality of smoking cessation and shared decision making among patients who smoke and are considering lung cancer screening. The centralized care strategy is a model where smokers eligible for lung cancer screening are referred to a dedicated tobacco treatment program where they receive both the shared decision-making and initiate smoking cessation counseling prior to their visit with a primary care provider. Utilizing the centralized care model may work better in helping people quit smoking and make informed decisions about lung cancer screening compared to usual care.

PRIMARY OBJECTIVE:

I. Test the effectiveness of usual care (primary care providers with training in guideline-based smoking cessation and shared decision making) versus (vs.) centralized care (smoking cessation and shared decision making delivered remotely by trained counselors) on smoking abstinence and the quality of patients' decisions about lung cancer screening.

SECONDARY OBJECTIVES:

I. Evaluate the reach, acceptability, feasibility, and fidelity of the two smoking cessation and shared decision-making implementation models in meeting the requirements from Centers for Medicare \& Medicaid Services (CMS) for the lung cancer screening patient counseling and shared decision making visit.

II. Conduct budget impact and cost-effectiveness analyses of the two implementation models for the smoking cessation and shared decision making to inform adoption of the intervention beyond the current study.

OUTLINE: Participants are randomized to 1 of 2 groups.

GROUP I (CENTRALIZED CARE): Participants receive counseling over the phone to help them quit smoking and learn about lung cancer screening over 15-20 minutes for 6-8 sessions over 8 weeks. Participants may also receive nicotine patches.

GROUP II (USUAL CARE): Participants receive counseling on lung cancer screening and smoking cessation from primary care providers at health care visit.

After completion of study, participants are followed up at 1, 8, and 12 weeks.

Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)

Improving the Quality of Smoking Cessation and Shared Decision Making for Lung Cancer Screening: A Cluster Randomized Trial

Participants achieving the primary abstinence endpoint at 12 weeks (higher 7-day point prevalence abstinence rates)

Knowledge of lung cancer screening and benefits of smoking cessation

Assessment of the reach of the intervention

Assessment of the feasibility of implementing the intervention

Standardized measure of health-related quality of life used to generate patient utilities (will report lower decisional conflict, greater decision preparation, greater intention to stop smoking, and be more likely to make an attempt to stop smoking.)

Costs of personnel, hardware, and delivering materials to participants

National Cancer Institute (NCI)

Cancer Prevention Research Institute of Texas

M.D. Anderson Cancer Center

Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, NRT, and self-help written materials.

Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.

Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.

Laboratory Biomarker Analysis

Undergo standard of care smoking cessation intervention

Smoking Cessation Intervention

Undergo telephone based smoking cessation intervention

Telephone-Based Intervention

Alexander V Prokhorov

This trial studies how well a mobile smoking cessation intervention works in enhancing cancer outreach in low-income adult smokers. Mobile smoking cessation intervention may help smokers quit or cut back on smoking, and help increase the range of cancer prevention services provided to low-income adult smokers.

PRIMARY OBJECTIVES:

I. Compare the efficacy of three smoking cessation interventions targeting community based low-income uninsured and underinsured individuals in a group-randomized trial.

II. Evaluate the role of quit motivation, nicotine withdrawal, risk perception, self-efficacy, social support, and negative affect as potential mediators of smoking abstinence.

III. Compare the cost-effectiveness of the three treatment conditions.

OUTLINE: Participants are randomized to 1 of 3 groups.

GROUP I (STANDARD CARE): Participants undergo standard of care smoking cessation intervention consisting of brief advice to quit smoking, nicotine replacement therapy (NRT), and self-help written materials.

GROUP II (ENHANCED CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number and supportive text messages daily for 12 weeks.

GROUP III (INTENSIVE CARE): Participants undergo standard of care smoking cessation intervention as in Group I and attend a health feedback counseling session at baseline. Participants also receive access to a smoking cessation hotline telephone number, supportive text messages daily for 12 weeks, and a smoking cessation telephone call over 15 minutes weekly for 12 weeks.

After completion of study, participants are followed up at 3, 6, and 12 months.

Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers

Project ACTION: Adult Smoking Cessation Treatment Through Innovative Outreach to Neighborhoods

The primary method of analysis will be mixed-model logistic regression.

Will perform an incremental cost-effectiveness analysis by comparing the expected economic costs and clinical benefits of the three strategies. Will create a decision-analytic model using TreeAge Pro 2007 software to conduct the incremental cost-effectiveness analysis.

Salivary cotinine will be measured using the NicAlert test system.

Carcinoma, Non-Small-Cell Lung

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Neoplasms, Squamous Cell

Head and Neck Neoplasms

Carcinoma, Bronchogenic

Bronchial Neoplasms

Psychotropic Drugs

Cardiotonic Agents

Bupropion

Varenicline

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients receive nicotine replacement therapy via trans-dermal patch, gum, nasal spray, inhaler or lozenges for 12 weeks in the absence of unacceptable toxicity. Patients also receive bupropion PO QD BID or varenicline PO QD and BID for 24 weeks in the absence of unacceptable toxicity. Patients undergo 3 cessation counseling sessions in person, via telehealth or phone within 7 days of enrollment into study, 1 week after established quit date and 3 weeks after establishing quit date.

Participants randomly assigned to the standard treatment (ST) group will receive an in-office smoking cessation recommendation by the physician and referral to a quit line.

Given NRT via trans-dermal patch, gum, nasal spray, inhaler or lozenges

Nicotine Replacement

Bupropion Hydrochloride Controlled-release

Quality of Life Assessment

This trial studies how well an enhanced tobacco intervention protocol (ETIP) works compared to standard treatment in helping head and neck and lung cancer patients starting treatment to reduce cigarette use. ETIP is an evidence-based tobacco cessation program including specialized one-to-one and telehealth counseling, drug therapy, nicotine replacement therapy, and frequent patient follow up. ETIP may help reduce smoking and improve cessation in patients with head and neck squamous cell cancer or non-small cell lung cancer.

PRIMARY OBJECTIVE:

I. To determine the feasibility of implementing a transdisciplinary ETIP using enrollment data and adherence to the intervention.

SECONDARY OBJECTIVE:

I. To compare smoking reduction, physiologic parameters and patient reported measures among patients in two tobacco treatment groups (ETIP and standard treatment \[ST\]).

TERTIARY OBJECTIVE:

I. To determine patient interest in wellness practices as a means to alter behavior and facilitate tobacco cessation.

EXPLORATORY OBJECTIVES:

I. To analyze the genetic profile, serum and tissue exosomal signatures, and immune cell profiles of both human papilloma virus (HPV) positive and negative tumor samples in patients who are never smokers, former smokers, and current smokers.

II. Compare these parameters in patients who underwent ETIP versus standard therapy.

III. To gather correlative data regarding the effects of tobacco smoke on the expression of biomarkers and the tumor microenvironment.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (ETIP): Patients receive nicotine replacement therapy via trans-dermal patch, gum, nasal spray, inhaler or lozenges for 12 weeks in the absence of unacceptable toxicity. Patients also receive bupropion orally (PO) once daily (QD) and twice daily (BID) or varenicline PO QD and BID for 24 weeks in the absence of unacceptable toxicity. Patients undergo 3 cessation counseling sessions in person, via telehealth or phone within 7 days of enrollment into study, 1 week after established quit date and 3 weeks after establishing quit date.

ARM II (ST): Patients receive standard treatment consisting of an in-office smoking cessation recommendation by the physician and referral to a quit line.

Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use

Feasibility of the Enhanced Tobacco Intervention Protocol (ETIP) to Reduce Smoking and Potentially Alter the Tumor Microenvironment of Head and Neck Squamous Cell Carcinoma and Non-Small Cell Lung Cancer

Descriptive statistics (means and standard deviations for continuous variable and frequencies for categorical variables) will be used to summarize interest in wellness programs.

Descriptive statistics (means and standard deviations for continuous variable and frequencies for categorical variables) will be used to summarize referred time and method of program delivery.

Immunohistochemistry (IHC) analysis will be done on all patient tissue samples at the initial visit. Additionally, serum blood samples will be collected from all patients. Serum c-reactive protein (CRP) and lipid levels will be tested at various time points in the study to account for changes in inflammatory marker expression. Peripheral blood assays, including Luminex, will be used to quantify immune mediators including expression of interferon (IFN)-gamma, IL-2, and IL-10 among other analytes.

This will be biochemically verified by any reductions in minor tobacco alkaloid (anabasine/anatabine) concentrations in the urine compared to baseline

Subjects with missing data will be counted as smokers

Participants will be asked to provide a urine sample for biochemical verification of smoking status with urine anatabine/anabasine testing at baseline, 1 and 6 months. We consider urine anabasine/anatabine less than or equal to 2 ng/ml to be evidence of abstinence. Participant failure to provide a sample will be interpreted as biochemical evidence of smoking.

Thomas Jefferson University

Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.

Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.

Placebo

Ivana Croghan, PhD

This randomized phase III trial studies how well management of a tobacco treatment intervention works in reducing surgical complications in patients with newly diagnosed lung cancer who smoke cigarettes. Management of a tobacco treatment intervention compares varenicline (a drug that reduces the craving and withdrawal symptoms that occur with abstinence from nicotine) and behavioral interventions (consisting of a brief clinician-delivered intervention and tobacco quitline \[tobacco cessation service available through a toll-free telephone number\] follow-up) with placebo (a pill with no active medication) along with similar behavioral interventions. It is not yet known whether management of a tobacco treatment intervention is more effective in reducing surgical complications than placebo.

PRIMARY OBJECTIVES:

I. To determine if varenicline plus a behavioral intervention consisting of a brief clinician-delivered intervention and tobacco quitline follow-up, decreases postsurgical complications through 24 weeks after surgery when compared to placebo plus the behavioral intervention in lung cancer patients who undergo surgery and are motivated to stop smoking.

SECONDARY OBJECTIVES:

I. To compare changes from baseline to 12 and 24 weeks after surgery in the patient quality of life (Linear Analogue Self-Assessment \[LASA\]-12) domains between the intervention (varenicline) and control group (placebo).

II. To compare changes from baseline to 6, 12 and 24 weeks after surgery in the patient quality of life related domains (LASA) for the Patient Health Questionnaire (PHQ)-9 and Smoking Self Efficacy Questionnaire (SEQ)12 between the intervention and control groups.

III. To compare the proportion of patients 12 weeks and 24 weeks after surgery who endorse ("Was It Worth It") each treatment (intervention versus \[vs\] control groups).

IV. To compare post-operative care (as measured by length of hospital and high dependency unit stay) between the intervention and control groups.

V. To compare treatment adherence between the intervention and control groups. VI. To compare rates of smoking abstinence between the intervention and control groups as a covariate of the primary outcome only.

Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes

Reducing Surgical Complications in Newly Diagnosed Lung Cancer Patients Who Smoke Cigarettes

Number of patients that died within 30 days of surgery

Number of patients re-hospitalized within 30 days of surgery

Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, Fagerström Test for Nicotine Dependence (FTND), time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

Surgical complication incidence rates at 24 weeks after surgery will be compared between the intervention vs. control groups using a Fisher's exact test. Logistic regression models will supplement the univariate analysis, using complication incidence as the dependent variable and will include smoking status at the time of surgery as an independent variable and also adjust for age, gender, FTND, time between randomization and surgery, and presence of adjuvant chemotherapy and/or radiation therapy. A separate logistic model will be created including treatment arm instead of smoking status. We will also explore the collinear relationship between arm and smoking status to see whether they can be included together in the logistic models.

Analysis of covariance and linear mixed model repeated measures analysis will be used for each assessment domain (LASA-12, PHQ-9, SEQ12).

Logrank testing of Kaplan-Meier estimates will be used for length of hospital stay and supplemented by Cox models to control for concomitant covariates.

Logrank testing of Kaplan-Meier estimates will be used for length of high dependency unit stay and supplemented by Cox models to control for concomitant covariates.

Pfizer

Alliance for Clinical Trials in Oncology

Tobacco Cessation Counseling: Complete counseling session

Intervention Group (Varenicline and Behavioral Intervention)

Control Group (Placebo and Behavioral Intervention)

Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Varenicline: Given PO\>

\> Tobacco Cessation Counseling: Complete counseling session

Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.\> \> Placebo: Given PO\>

\> Tobacco Cessation Counseling: Complete counseling session

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Dr. Ivana T. Croghan

Mortality

Re-hospitalization

Patients receive varenicline PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.

\>

\> Varenicline: Given PO

\>

\> Tobacco Cessation Counseling: Complete counseling session

Patients receive placebo PO QD on days 1-3 and BID on days 4-84 for 12 weeks in the absence of disease progression or unacceptable toxicity. Patients also complete behavioral intervention consisting of no smoking message from surgical team member and how to use NCI quitline at surgical consult.

\>

\> Placebo: Given PO

\>

\> Tobacco Cessation Counseling: Complete counseling session

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Provider Training in Increasing Patient Tobacco Cessation Counseling and Referrals for Patients With Cancer Undergoing Radiation Therapy	NCT03135782	Breast Carcinom... Caregiver Head and Neck C... Lung Carcinoma Prostate Carcin... Tobacco Use	Communication S... Medical Chart R... Questionnaire A... Tobacco Cessati...	-	OHSU Knight Cancer Institute
Centralized Lung Cancer EARly Detection Among Smokers (CLEAR Study)	NCT04200534	Smoking Lung Cancer	Best Practice Nicotine Patch Quality-of-Life... Questionnaire A... Tobacco Cessati...	55 Years - 77 Years	M.D. Anderson Cancer Center
Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers	NCT00948129	Cigarette Smoke... Current Every D...	Laboratory Biom... Smoking Cessati... Telephone-Based... Tobacco Cessati...	18 Years -	M.D. Anderson Cancer Center
Effectiveness of an Enhanced Tobacco Intervention Protocol Compared to Standard Treatment in Helping Head and Neck and Lung Cancer Patients Starting Treatment to Reduce Cigarette Use	NCT04694846	Lung Non-Small ... Head and Neck S...	Nicotine Replac... Bupropion Hydro... Varenicline Tobacco Cessati... Questionnaire A... Quality of Life... Best Practice	18 Years -	Thomas Jefferson University
Mobile Smoking Cessation Intervention in Enhancing Cancer Outreach in Low-Income Adult Smokers	NCT00948129	Cigarette Smoke... Current Every D...	Laboratory Biom... Smoking Cessati... Telephone-Based... Tobacco Cessati...	18 Years -	M.D. Anderson Cancer Center
Management of Tobacco Treatment Intervention in Reducing Surgical Complications in Patients With Newly Diagnosed Lung Cancer Who Smoke Cigarettes	NCT02856581	Lung Carcinoma	Varenicline Placebo Tobacco Cessati...	18 Years -	Alliance for Clinical Trials in Oncology

Spots Global Cancer Trial Database for tobacco cessation counseling