Phase 4
N=52
Tobacco Treatment Comparison for Cancer Care
Smoking Cessation · Cancer
Bottom Line
View on ClinicalTrials.gov: NCT06218823 ↗Enrolled (actual)
52
Serious AEs
26.9%
Results posted
Oct 2025
Primary outcome: Primary: Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date. — 2; 7 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Transdermal Nicotine Patch (Drug); Standard Telephone Counseling (Behavioral); Varenicline (Drug); Cancer-Targeted Telephone Counseling (Behavioral); Mailed Information about Standard Care Resources (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Wisconsin, Madison
- Primary completion
- Aug 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date. |
2; 7 | — |
| SECONDARY Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date. |
6; 9 | — |
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.
Eligibility Criteria
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).
Data sourced from ClinicalTrials.gov (NCT06218823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.