Tobacco Treatment Comparison for Cancer Care

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

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.

Study Overview

• Status: Completed
• Conditions: Smoking Cessation; Cancer
• Intervention / Treatment: Drug: Transdermal Nicotine Patch; Behavioral: Standard Telephone Counseling; Other: Mailed Information about Standard Care Resources; Drug: Varenicline; Behavioral: Cancer-Targeted Telephone Counseling

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.

• Study Type: Interventional
• Enrollment (Actual): 52
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53792
      • UW Carbone Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Alive (per medical record)
• Diagnosed with cancer in the past 3 years
• Received care from a participating oncology clinic in the past year
• Has a current tobacco use status
• Does not have a preferred language other than English (missing language preference will be included).
• Valid address that is not a correctional facility or residential treatment/care facility.
• No flag for patient cognitive impairment, activated health care power of attorney, or other health care agent (e.g., legally authorized representative) in the EHR.

The following additional inclusion criteria must be met for inclusion in the CET

• Smoked combustible cigarettes in the past month.
• Able to speak and understand English.
• Willing to set a date to quit smoking in the next 60 days.
• Willing to receive smoking treatment information.
• Willing to complete study activities.

Exclusion Criteria:

• No current suicidal ideation.
• Suicide attempt in the past year.
• Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder.
• Incarceration.
• Unable to provide informed consent to treatment (i.e., cannot answer questions about study procedures or risks after hearing about the study).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Low-Intensity Standard Smoking Cessation Treatment; 2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)	Drug: Transdermal Nicotine Patch; a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours; Other Names: NicoDerm CQ; Nicotine Patch; Behavioral: Standard Telephone Counseling; 3 brief telephone-based smoking cessation counseling sessions; 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.
Experimental: High-Intensity, Cancer-Targeted Smoking Cessation Treatment; 12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services	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.; Drug: Varenicline; 12 weeks of an oral smoking cessation medication; Other Names: apovarenicline; Behavioral: Cancer-Targeted Telephone Counseling; 7 telephone-based smoking cessation counseling sessions adapted for cancer patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date.	This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.	up to 30 weeks post target quit date

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.	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?".	up to 13 weeks post target quit date

Collaborators and Investigators

• Sponsor: University of Wisconsin, Madison
• Collaborators: National Cancer Institute (NCI)
• Investigators: Principal Investigator: Danielle E McCarthy, PhD, University of Wisconsin, Madison

Publications and helpful links

Helpful Links

• UW Center for Tobacco Research and Intervention

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Actual): August 4, 2025
• Study Completion (Actual): August 4, 2025

Study Registration Dates

• First Submitted: January 12, 2024
• First Submitted That Met QC Criteria: January 12, 2024
• First Posted (Actual): January 23, 2024

Study Record Updates

• Last Update Posted (Estimated): October 27, 2025
• Last Update Submitted That Met QC Criteria: October 14, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Behavior; Health Behavior; Neoplasms; Smoking Cessation; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Therapeutics; Alkaloids; Benzazepines; Quinoxalines; Solanaceous Alkaloids; Varenicline; Nicotine; Tobacco Use Cessation Devices
• Other Study ID Numbers: 2023-1025; SMPH/MEDICINE/GEN INT MD (Other Identifier: UW Madison); 2P01CA180945-06 (U.S. NIH Grant/Contract); UW23091 (Other Identifier: UWCCC); Protocol Version 2/13/2024 (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Access Criteria: Data will only be shared under the auspices of an approved and executed Data Use Agreement, in accordance with university regulations.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No