Tobacco Treatment Comparison for Cancer Care

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT06218823
• Other study ID #: 2023-1025
• Secondary ID: Protocol Version
• Status: Enrolling by invitation
• Phase: Phase 4
• Start date: March 1, 2024
• Est. completion date: June 2027

Study information

• Verified date: March 2024
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 50
• Est. completion date: June 2027
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Cancer
• Smoking Cessation

Intervention

Drug:
• Transdermal Nicotine Patch
a stop smoking aid, 21 milligrams(mg), 14mg, or 7mg of nicotine delivered over 24 hours

Behavioral:
• Standard Telephone Counseling
3 brief telephone-based smoking cessation counseling sessions

Drug:
• Varenicline
12 weeks of an oral smoking cessation medication

Behavioral:
• Cancer-Targeted Telephone Counseling
7 telephone-based smoking cessation counseling sessions adapted for cancer patients

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.

Locations

Country	Name	City	State
United States	UW Carbone Cancer Center	Madison	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
University of Wisconsin, Madison	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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