Tobacco Treatment Comparison for Cancer Care

NCT06218823 | Completed Phase 4 Results FDA Drug

• 5 other identifiers: 2023-1025Protocol Version 2/13/2024SMPH/MEDICINE/GEN INT MD2P01CA180945-06UW23091
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation; Cancer

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.

  up to 13 weeks post target quit date

Study Arms (2)

Low-Intensity Standard Smoking Cessation Treatment

ACTIVE COMPARATOR

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; Behavioral: Standard Telephone Counseling; Other: Mailed Information about Standard Care Resources

High-Intensity, Cancer-Targeted Smoking Cessation Treatment

EXPERIMENTAL

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

Drug: Varenicline; Behavioral: Cancer-Targeted Telephone Counseling; Other: Mailed Information about Standard Care Resources

Interventions

Transdermal Nicotine Patch DRUG

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

Also known as: Nicotine Patch, NicoDerm CQ

Low-Intensity Standard Smoking Cessation Treatment

Standard Telephone Counseling BEHAVIORAL

3 brief telephone-based smoking cessation counseling sessions

Low-Intensity Standard Smoking Cessation Treatment

Varenicline DRUG

12 weeks of an oral smoking cessation medication

Also known as: apovarenicline

High-Intensity, Cancer-Targeted Smoking Cessation Treatment

Cancer-Targeted Telephone Counseling BEHAVIORAL

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

High-Intensity, Cancer-Targeted Smoking Cessation Treatment

Mailed Information about Standard Care Resources OTHER

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

High-Intensity, Cancer-Targeted Smoking Cessation Treatment; Low-Intensity Standard Smoking Cessation Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

Location

Related Links

• UW Center for Tobacco Research and Intervention

MeSH Terms

Conditions

Smoking Cessation; Neoplasms

Interventions

Tobacco Use Cessation Devices; Nicotine; Varenicline

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics; Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Quinoxalines

Results Point of Contact

• Title: Associate Director of Research
• Organization: University of Wisconsin Center for Tobacco Research and Intervention

demccarthy@ctri.wisc.edu

6082628673

Study Officials

• Danielle E McCarthy, PhD

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 12, 2024
• First Posted: January 23, 2024
• Study Start: March 1, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: October 27, 2025
• Results First Posted: October 27, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Access Criteria: Data will only be shared under the auspices of an approved and executed Data Use Agreement, in accordance with university regulations.

Locations

US (1)