Smoking CessationPhase 4NCT06218823
Tobacco Treatment Comparison for Cancer Care
A Phase 4 study testing Transdermal Nicotine Patch, Standard Telephone Counseling and Varenicline in people with Smoking Cessation and Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Smoking Cessation, Cancer
- What is being tested?
- Transdermal Nicotine Patch, Standard Telephone Counseling and Varenicline
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2024to 4 Aug 2025
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Smoking Cessation, Cancer
- Being tested
- Transdermal Nicotine Patch, Standard Telephone Counseling, Varenicline, Cancer-Targeted Telephone Counseling, Mailed Information about Standard Care Resources
- Medical subject headings
- Smoking Cessation, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transdermal Nicotine PatchDrug
Also called Nicotine Patch, NicoDerm CQ
a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours
Standard Telephone CounselingBehavioural
3 brief telephone-based smoking cessation counseling sessions
VareniclineDrug
Also called apovarenicline
12 weeks of an oral smoking cessation medication
Cancer-Targeted Telephone CounselingBehavioural
7 telephone-based smoking cessation counseling sessions adapted for cancer patients
Mailed Information about Standard Care ResourcesOther
Publicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: 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 Receives: Drug: Varenicline; Behavioral: Cancer-Targeted Telephone Counseling; Other: Mailed Information about Standard Care Resources |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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?".
Measured: up to 13 weeks post target quit date
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2024
- Study start1 Mar 2024
- Primary completion4 Aug 2025
- Study completion4 Aug 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Danielle E McCarthy, PhD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06218823
- Sponsor's protocol ID
- 2023-1025
- Other IDs
- Protocol Version 2/13/2024, SMPH/MEDICINE/GEN INT MD, 2P01CA180945-06, UW23091
- Status last verified
- Oct 2025
- First submitted
- 12 Jan 2024
- Last updated
- 27 Oct 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Effectiveness Trial of Tobacco Cessation Treatments Among Cancer Patients Who Smoke
- ClinicalTrials.gov ID
- NCT06218823
- Acronym / sponsor ID
- 2023-1025
- Conditions
- Smoking Cessation, Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 4 Aug 2025 (actual)
- Study completion
- 4 Aug 2025 (actual)
- First posted
- 23 Jan 2024 (actual)
- Results
- Posted 27 Oct 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low-Intensity Standard Smoking Cessation Treatment | Active comparator | Drug: Transdermal Nicotine Patch, Behavioral: Standard Telephone Counseling, Other: Mailed Information about Standard Care Resources2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT) |
| High-Intensity, Cancer-Targeted Smoking Cessation Treatment | Experimental | Drug: Varenicline, Behavioral: Cancer-Targeted Telephone Counseling, Other: Mailed Information about Standard Care Resources12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- 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).
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transdermal Nicotine PatchAlso: Nicotine Patch, NicoDerm CQa stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours | Drug | Low-Intensity Standard Smoking Cessation Treatment |
| Standard Telephone Counseling3 brief telephone-based smoking cessation counseling sessions | Behavioural | Low-Intensity Standard Smoking Cessation Treatment |
| VareniclineAlso: apovarenicline12 weeks of an oral smoking cessation medication | Drug | High-Intensity, Cancer-Targeted Smoking Cessation Treatment |
| Cancer-Targeted Telephone Counseling7 telephone-based smoking cessation counseling sessions adapted for cancer patients | Behavioural | High-Intensity, Cancer-Targeted Smoking Cessation Treatment |
| Mailed Information about Standard Care ResourcesPublicly funded treatment resources including the SmokefreeTXT program sponsored by the National Cancer Institute and the Wisconsin Tobacco Quit Line. | Other | High-Intensity, Cancer-Targeted Smoking Cessation Treatment, Low-Intensity Standard Smoking Cessation Treatment |
Primary outcome
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.
1 secondary outcome
Self-reported 7-day Point-prevalence Abstinence 12 Weeks After a Target Quit Date.
Time frame: up to 13 weeks post target quit date
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- UW Center for Tobacco Research and InterventionLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danielle E McCarthy, PhD principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Transdermal Nicotine Patch, Standard Telephone Counseling and Varenicline in people with Smoking Cessation and Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biochemically Verified 7-day Point-prevalence Abstinence 26 Weeks After a Target Quit Date. (time frame: up to 30 weeks post target quit date). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2025.