All Drugs and Chemicals

Central Nervous System Stimulants

Nicotine

Varenicline

Nicotinic Agonists

Cholinergic Agents

Neurotransmitter Agents

2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)

12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services

a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours

Transdermal Nicotine Patch

3 brief telephone-based smoking cessation counseling sessions

Standard Telephone Counseling

12 weeks of an oral smoking cessation medication

7 telephone-based smoking cessation counseling sessions adapted for cancer patients

Cancer-Targeted Telephone Counseling

Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.

Mailed Information about Standard Care Resources

Danielle E McCarthy, PhD

This pilot comparative effectiveness trial will compare two active smoking cessation treatments in terms of effectiveness, equity across patient subpopulations, and efficiency among adult patients diagnosed with cancer within the past 3 years. An enhanced treatment comprising 12 weeks of varenicline treatment and 7 smoking cessation coaching calls with a cancer focus will be compared against an active comparator modeled after standard quitline treatments (2 weeks of nicotine patch therapy with 3 phone coaching calls). Approximately 50 participants will be recruited to generate estimates of the effects, acceptability, costs, and equity of enhanced treatment (vs. standard treatment), with the primary outcome being abstinence from smoking 26 weeks after trying to quit.

Primary Aim

1. To generate estimates of the size of the comparative effects of enhanced, cancer-specific smoking cessation treatment versus a generic standard care package similar to quitline care in terms of biochemically confirmed 7-day point prevalence abstinence (no smoking in the past 7 days) 26 weeks after a target quit date.

Exploratory Aims

1. To estimate differences in CET arms in exploratory outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness.
2. To estimate the extent to which treatment effects on abstinence and exploratory outcomes differ across patient subpopulations based on demographics (age, race, sex, ethnicity, socioeconomic disadvantage); nicotine dependence; and cancer site, stage, and treatment phase.

Tobacco Treatment Comparison for Cancer Care

Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke

Aggregate results from this research will be shared with the scientific community and our research collaborators. The findings from this research will also be shared upon request with study participants.

This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.

This measure is a self-report response at the 12 week telephone follow-up to the question "Have you smoked, even a puff, in the last 7 days?".

National Cancer Institute (NCI)

University of Wisconsin, Madison

Substance Related Disorders

Behaviors and Mental Disorders

All Conditions

Tobacco Use Disorder

Substance-Related Disorders

Chemically-Induced Disorders

Mental Disorders

Psychotic Disorders

8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg.

Transdermal nicotine patch

Robert A Schnoll, PhD

A teachable moment (TM) refers to life events or transitions, such as physician visits, early detection screening feedback, pregnancy, and hospitalization for, and diagnosis of, disease, that inspire health behavior change. Despite strong intuitive appeal of the TM concept and over 150 studies of interventions implemented in a TM, there has been little investigation of the influence of TMs for smoking, particularly for promoting smoking cessation among those indirectly affected by a TM (e.g., relatives of cancer patients). This prospective observational study using a matched-group design will assess whether a lung cancer diagnosis increases enrollment in a smoking cessation program and cessation, and reduces smoking, among the patient's relatives/spouse who smoke. We will compare enrollment in a cessation program and cessation and smoking rates in 2 groups of smokers: 1) relatives/spouses of newly-diagnosed lung cancer patients, and 2) relatives/spouses of patients with an orthopedic condition. We will also explore mediators and moderators of a lung cancer diagnosis as a TM. This study could clarify the TM concept for smoking cessation, shed light on the underlying mechanisms of TMs, and guide future development and implementation of TM-based smoking cessation interventions.

Assessment of a Teachable Moment for Smoking Cessation

National Institutes of Health (NIH)

University of Pennsylvania

Associate Professor

Relatives of Cancer Patients offered Transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling.

Relatives of Cancer Patients

Relatives of Orthopedic Patients offered transdermal nicotine patch: 8 weeks; 4 weeks of 21mg, 2 weeks of 14mg, and 2 weeks of 7mg and behavioral counseling

Relatives of Orthopedic Patients

Total

Age, Continuous

Sex: Female, Male

Dr. Robert Schnoll

Accrual Rate (Eligibility Visit)

The 129 participants represents a subset of the sample that participated in treatment. This subset of participants includes only those who attended eligibility session and participated in the week 9 follow-up. One oncology relative became ineligible immediately following completion of this counseling session and was excluded.

Smoking Cessation Rate

This analysis includes only a subset of participants who had not discontinued the study by week 1.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tobacco Treatment Comparison for Cancer Care	NCT06218823	Smoking Cessati... Cancer	Transdermal Nic... Standard Teleph... Varenicline Cancer-Targeted... Mailed Informat...	18 Years -	University of Wisconsin, Madison
Assessment of a Teachable Moment for Smoking Cessation	NCT00596440	Nicotine Depend...	Transdermal nic...	18 Years -	University of Pennsylvania
Assessment of a Teachable Moment for Smoking Cessation	NCT00596440	Nicotine Depend...	Transdermal nic...	18 Years -	University of Pennsylvania
Tobacco Treatment Comparison for Cancer Care	NCT06218823	Smoking Cessati... Cancer	Transdermal Nic... Standard Teleph... Varenicline Cancer-Targeted... Mailed Informat...	18 Years -	University of Wisconsin, Madison

Spots Global Cancer Trial Database for transdermal nicotine patch