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

Nutritional and Metabolic Diseases

Gland and Hormone Related Diseases

All Conditions

Heart and Blood Diseases

Symptoms and General Pathology

Respiratory Tract (Lung and Bronchial) Diseases

Rare Diseases

Diabetes Mellitus

Hypertension

Chronic Disease

Lung Diseases

Pulmonary Disease, Chronic Obstructive

Respiratory Tract Diseases

Disease Attributes

Lung Diseases, Obstructive

Chronic Graft Versus Host Disease

Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking

Family-supported

Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

Standard Telephone counseling

Lori Anne Bastian, MD MPH

The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.

ANTICIPATED IMPACT(S) ON VETERAN'S HEALTHCARE:

Veterans with chronic disease who continue to smoke exact a significant burden on the VA health care system. Effective smoking cessation programs, that target veterans who continue to smoke after the diagnosis of a smoking-related chronic illness, are needed.

BACKGROUND/RATIONALE:

Chronic diseases related to tobacco exposure are common among veterans. Persistent tobacco use after being diagnosed with these diseases decreases quality of life and survival. Yet, 30% of veterans with these conditions continue to smoke. Researchers have found that the social environment is important for smokers. In our current NCI-funded study, 70% of veterans with lung cancer identified at least one family member who smokes and 45% live with a family member that smokes. A family-supported smoking cessation intervention timed to follow a veteran's diagnosis of cancer or heart disease could be effective for helping veterans quit smoking.

OBJECTIVES:

The overarching aim of the study is to evaluate in a randomized trial the impact of a family-supported intervention compared to a standard veteran-focused telephone counseling control group to promote smoking cessation among cancer and heart disease patients.

AIM 1: To evaluate the impact of a family-supported intervention on rates of abstinence from cigarettes (self-reported 7-day point prevalent abstinence) at 2 weeks, and 12-month post-treatment follow-ups.

Hypothesis 1: Abstinence rates will be significantly higher among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.

AIM 2: To evaluate the impact of a family-supported intervention on perceived support for quitting 2 weeks and 12-month post-treatment follow-ups.

Hypothesis 2: Perceived support for quitting smoking will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.

AIM 3: To measure the impact of a family-supported intervention on quality of life in veterans 2 weeks, and 12-month post-treatment follow-ups.

Hypothesis 3: Symptom-related quality of life will be significantly greater among veterans who receive the family-supported intervention than those who receive the standard telephone counseling control.

METHODS: Proposed is a two-group design in which 470 veterans who smoke will be randomized to receive:

STANDARD TELEPHONE COUNSELING control including a letter from a VA physician encouraging the patient to quit smoking, nicotine replacement (if not contraindicated), a self-help cessation kit, and 5 standard telephone counseling calls; or FAMILY-SUPPORTED intervention that includes all components of the control arm plus a Family-supported intervention that includes a support skills booklet and an additional telephone counseling protocol focusing on social support. .

Family-supported Smoking Cessation for Chronically Ill Veterans

Family-Supported Smoking Cessation for Chronically Ill Veterans

self-reported 7-day point prevalent abstinence

self-reported 7- day point prevalent abstinence

US Department of Veterans Affairs

Family-supported smoking cessation

Family-supported: Group receives quit kit, option for nicotine replacement therapy, and 5 telephone counseling sessions with the goal of attaining social support during the process of quitting smoking

Arm 1

Standard smoking cessation

Standard Telephone counseling: Group receives quit kit, option for nicotine replacement therapy, and 5 standard smoking cessation telephone counseling sessions

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
Family-supported Smoking Cessation for Chronically Ill Veterans	NCT00448344	Chronic Disease Neoplasm Cardiovascular ... Pulmonary Disea... Diabetes Mellit... Hypertension	Family-supporte... Standard Teleph...	18 Years -	VA Office of Research and Development
Family-supported Smoking Cessation for Chronically Ill Veterans	NCT00448344	Chronic Disease Neoplasm Cardiovascular ... Pulmonary Disea... Diabetes Mellit... Hypertension	Family-supporte... Standard Teleph...	18 Years -	VA Office of Research and Development
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 standard telephone counseling