Behaviors and Mental Disorders

All Conditions

Neoplasms

Behavior, Addictive

Neoplasms, Second Primary

Psychotropic Drugs

All Drugs and Chemicals

Central Nervous System Stimulants

Cardiotonic Agents

Bupropion

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

Antidepressive Agents

Dopamine

Dopamine Uptake Inhibitors

Dopamine Agents

Enzyme Inhibitors

Cytochrome P-450 Enzyme Inhibitors

Patients diagnosed with tobacco-related treatment will receive varenicline, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive varenicline and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive Buproprion, counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive Buproprion and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch), counseling, and nicotine replacement therapy (PRN NRT). Dose and frequency will be based on patient preference, smoking history and other medical factors.

Patients diagnosed with tobacco-related treatment will receive long acting nicotine replacement therapy (e.g. nicotine patch) and counseling. Dose and frequency will be based on patient preference, smoking history and other medical factors.

Varenicline therapy will be 12-week course. On days 1-3 participants will receive 0.5mg once daily; days 4-7 receive 0.5mg twice daily and day 8 until the end of treatment receive 1mg twice daily.

Patients will begin with a dose of 150 mg every morning for 3 days. Then dosage will increase to 150 mg twice daily (morning and evening), for a total daily dose of 300 mg, for 7 to 12 weeks.

Nicotine replacement therapy (NRT) patches will be used daily from 1-10 weeks depending on participant's smoking history.

Long-acting nicotine replacement therapy

A study coordinator or a member of the treatment team will provide a minimum level of initial counseling, approximately 10-20 minutes in length.

Low-intensity counseling

A counselor will provide eight sessions in the first 8 weeks of the study. Up to three follow up sessions over the next 4 months of study will be encouraged, but not required.

High-intensity counseling

Participants in this group will not receive per required need nicotine replacement therapy.

No nicotine replacement therapy

Participants in this group will receive per required need nicotine replacement therapy.

Nicotine Replacement Products

Joseph Valentino, MD

David Goebel, MD

Tina Berger

Vanissa Sorrels

Smoking cessation has been shown to improve the effectiveness and reduce the morbidity of tobacco-related cancer treatments. We will identify effective smoking cessation strategies for patients who are receiving treatment for tobacco-related cancer. In this trial, patients' preferences in smoking cessation therapy will be the principal determinant by providers in developing a three component regimen of pharmaceutical therapy, counseling, and nicotine replacement therapy. This study will identify this cohort's preferences for smoking cessation strategies. We will then examine the impact of utilizing patient preferences upon cessation efficacy by directly comparing cessation success in this study with our recently completed study of the same population using the same tobacco treatments which were randomly assigned.

Background Cigarette smoking is associated with decreased survival and decreased efficacy of cancer therapy in those with smoking related malignancies. There is limited of study of smoking cessation for cancer patients being treated in regions with high tobacco use such as Kentucky. There is little study of cessation implementation in the community cancer treatment setting where the majority of cancer patients receive their cancer therapy. Most smokers have significant exposure to information and personal experience with tobacco treatments which, in some cases, leads to profound preferences. The effect of incorporating these patient preferences into tobacco treatment planning has not been studied or quantified.

Study Design Phase II therapeutic clinical trial.

Setting University of Kentucky Markey Cancer Center (MCC) and its affiliate research network of Community Cancer Centers (MCCRN)

Methods Ninety-three subjects will be selected. All subjects will be active smoking oncology patients with a diagnosis of smoking related malignancy who are beginning a new course of therapy. In conjunction with their treating clinician, all subjects will be counseled and then select one of 12 cessation strategies. This will include a choice of continuous pharmacologic agent (veranicline, bupropion or transdermal nicotine patch), counseling strategy (11 session high intensity motivational based counseling or single session low intensity counseling), and whether or not to use as needed nicotine (gum, lozenges or spray).

Data Analysis All subjects will be followed for six months. The primary endpoint will be a carbon monoxide monitoring confirmed negative seven-day point prevalence report of cessation at eight weeks. Data will then be analyzed and compared with a completed randomized clinical trial of the same treatment strategies in the same population of subjects where the cessation strategy was assigned (historical control). The proportion of subjects that have quit at week eight will be compared to the historical control proportion (namely, whether Ho:p=po vs Ha: p\>po). This will be assessed using a z-score for a binomial proportion which will test whether the underlying proportion quitting at eight weeks (p) differs from the control proportion (po ranging from 0.215 to 0.26) estimated from our recently completed randomized trial of these same 12 cessation strategies.

This trial is a parallel design. However, it is part of a broader sequential cohort design to compare the effects of preference driven tobacco treatment upon cessation versus effects of a previous cohort from a separate randomized controlled trial.

Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment

Number of patients requiring financial assistance with medication.

Number of patients with alteration in therapy due to ongoing cancer treatment.

Proportion of treatments covered by insurance/third party.

Proportion of participants that quit smoking at the 8 week assessment

Seven day point prevalence of cigarette use will be determined from participant reports and CO testing.

Proportion of participants preferring the treatment plan.

Cigarette use will be recorded at weeks one, four, eight and at 6 months.

Subjects who complete 75% of the planned dosages of therapy will be considered compliant.

Subjects who complete 60% of planned therapy sessions will be considered compliant.

Professor

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Participants receive the usual care approach, Ask-Advise-Refer (AAR), which is a standard approach in which non-study clinicians ask smokers about their desire to quit smoking, advise them to quit, and provide informational resources such as hotlines, specialized clinics, or smoking cessation classes.

Participants receive the basic usual care of Ask-Advise-Refer as well as free access to nicotine replacement therapy (NRT) and/or reimbursement of up to $300 for any smoking cessation medications (varenicline/Chantix or bupropion/Zyban) prescribed by non-study clinicians.

Participants receive all aspects of enhanced usual care plus an incentive plan in which they will be informed of their eligibility to earn $100, $200, and $300 if they submit negative tests for nicotine metabolites at 2 weeks, 3 month and 6 months following their quit date, respectively.

Participants receive all aspects of Arm 3 plus an intervention to promote episodic future thinking (EFT), called FutureMe. EFT has been shown to reliably reduce discounting of the future. Patients will practice using EFT cues to envision the "future is now" between the time of enrollment and the quit date, and will then receive cues from the quit date through the end of the intervention period, 6 months later, unless they ask to stop receiving cues sooner.

Free access to nicotine replacement therapies and/or reimbursement for smoking cessation prescription medications

Removal of Financial Barriers

Financial incentive plan of up to $600 for biochemically-confirmed, sustained abstinence for 6 months.

Financial Incentives

Episodic future thinking tool to overcome temporal discounting of future

Mobile Health Application

Shira Blady, BS

Vanessa Madden

Michael Gould, MD MS

Mohamed Ismail, MD MPH

Christine Neslund-Dudas, PhD

Michael Simoff, MD

Matthew Facktor, MD

Charlotte Collins, PhD

Scott D Halpern, MD PhD

Scott Halpern, MD PhD

Anil Vachani, MD MS

Joanna Hart, MD MS

Kevin Volpp, MD PhD

Rachel Kohn, MD MS

Dylan Small, PhD

Alisa Stephens-Shields, PhD

To compare the effectiveness of four interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among underserved smokers referred for lung cancer screening at four large U.S. health systems.

We will conduct a 4-arm randomized trial comparing 4 interventions to promote sustained, biochemically confirmed smoking abstinence for 6 months among smokers in underserved demographic groups. The 3,200 participants to be enrolled will be current smokers who are Black, Hispanic, and/or have low socioeconomic status (defined as household income \<200% of the federal poverty line or a high school education or less) or rural residence who are referred for low-dose computed tomography (LDCT) screening at 4 large health systems. All adult patients with LDCT orders will be further screened for eligibility. Eligible patients will enroll with opt-out consent and complete the study using the NIH-funded Way to Health online research portal. The primary outcome will be biochemically confirmed, sustained abstinence from smoking tobacco for 6 months following participants' selected quit dates. Relapse rates will be tracked at 12 months.

This is a prospective randomized controlled trial using opt-out consent with longitudinal follow-up of patients over 12 months. Based on the expected accrual at each of the four health systems, we expect that overall there will be 470 participants in basic usual care (Arm 1), and 910 participants in each of intervention arms 2-4.

Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening

Individual participant data that underlie published results will be made available to other researchers, after de-identification.

The primary outcome measure is sustained abstinence for 6 months, and will require self-report of smoking cessation followed by biochemical confirmation at 2 weeks, 3, and 6 months.

Point-prevalent rates of self-reported nicotine use and tobacco product use

Point-prevalent rates of biochemically confirmed smoking cessation

The EuroQuol Group's quality of life (EQ-5D) scale is a 25-item validated scale used to assess patients' perceived health-related quality of life across the domains of mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.

The Challenges to Stopping Smoking Scale (CSS-21) is a validated 21-item measure to assess patients' perceived barriers to smoking cessation. The CSS-21 has two sub-scales: intrinsic factors (physical, psychological or cognitive aspects of quitting) and extrinsic factors (social or environmental aspects of quitting).

We will use the 10-item situational measure of self-efficacy related to smoking behavior. This scale measures how sure participants are that they can avoid smoking in different situations.

The Stages of Change (SOC) is a validated 1-item measure to assess patient's self-reported motivation to quit.

Temporal discounting is a measure of impulsivity that reflects people's tendencies to discount the value of a reward as a function of how far in the future it would be received. We will use the 5-Trial Adjusting Delay Task to assess temporal discounting.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment	NCT04634071	Smoking Cessati... Cancer, Treatme...	Varenicline Bupropion Long-acting nic... Low-intensity c... High-intensity ... No nicotine rep... Nicotine Replac...	18 Years -	University of Kentucky
Tobacco Treatment Optimization and Preferences During Concurrent Cancer Treatment	NCT04634071	Smoking Cessati... Cancer, Treatme...	Varenicline Bupropion Long-acting nic... Low-intensity c... High-intensity ... No nicotine rep... Nicotine Replac...	18 Years -	University of Kentucky
Comparing Smoking Cessation Interventions Among Underserved Patients Referred for Lung Cancer Screening	NCT04798664	Smoking Cessati...	Removal of Fina... Financial Incen... Mobile Health A...	18 Years -	University of Pennsylvania

Spots Global Cancer Trial Database for nicotine replacement products