NCT06218823

Tobacco Treatment Comparison for Cancer Care

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Smoking Cessation
• Cancer

Interventions

Type	Name	Description
DRUG	Transdermal Nicotine Patch	a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours
BEHAVIORAL	Standard Telephone Counseling	3 brief telephone-based smoking cessation counseling sessions
DRUG	Varenicline	12 weeks of an oral smoking cessation medication
BEHAVIORAL	Cancer-Targeted Telephone Counseling	7 telephone-based smoking cessation counseling sessions adapted for cancer patients
OTHER	Mailed Information about Standard Care Resources	Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.

Timeline

• Start date: 2024-03-01
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2024-01-23
• Last updated: 2025-10-27
• Results posted: 2025-10-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study