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OpenTrials
Completed

NCT Number: NCT06218823

Tobacco Treatment Comparison for Cancer Care

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.

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Key information

Conditions

Smoking Cessation Behavior Cancer Health Behavior Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

UW Carbone Cancer Center

Madison, Wisconsin, 53792, United States

About this study

Primary Aim

  • 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

  • To estimate differences in CET arms in exploratory outcomes including patient acceptability, completion, adherence, costs, and cost-effectiveness.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Transdermal Nicotine Patch

Drug

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

Other names: Nicotine Patch, NicoDerm CQ

Standard Telephone Counseling

Behavioral

3 brief telephone-based smoking cessation counseling sessions

Varenicline

Drug

12 weeks of an oral smoking cessation medication

Other names: apovarenicline

Cancer-Targeted Telephone Counseling

Behavioral

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

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.

Primary outcomes

  1. Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date.

    Time frame: up to 30 weeks post target quit date

    This measure is confirmed by expired carbon monoxide and/or a cotinine urine or saliva sample test.

Secondary outcomes

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

    Time frame: up to 13 weeks post 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?".

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Collaborators

  • National Cancer Institute (NCI)

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jan 23, 2024
Registry last updated
Oct 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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