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Brief Title: Tobacco Treatment Comparison for Cancer Care
Official Title: Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke
Study ID: NCT06218823
Brief Summary: 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.
Detailed Description: 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.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
UW Carbone Cancer Center, Madison, Wisconsin, United States
Name: Danielle E McCarthy, PhD
Affiliation: University of Wisconsin, Madison
Role: PRINCIPAL_INVESTIGATOR