Tobacco Treatment Comparison for Cancer Care

Phase 4

Active, not recruiting

• Conditions: Cancer; Smoking Cessation
• Interventions: Drug: Transdermal Nicotine Patch; Drug: Varenicline; Behavioral: Standard Telephone Counseling; Behavioral: Cancer-Targeted Telephone Counseling; Other: Mailed Information about Standard Care Resources

• Registration Number: NCT06218823
• Lead Sponsor: University of Wisconsin, Madison

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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-01-12
• Study First Submitted QC: 2024-01-12
• Study First Posted: 2024-01-23
• Study Start: 2024-03-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-02
• Last Update Posted: 2024-12-04
• Primary Completion: 2025-08
• Study Completion: 2025-08

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 52

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.

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low-Intensity Standard Smoking Cessation Treatment	Transdermal Nicotine Patch	2 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	Mailed Information about Standard Care Resources	12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
Low-Intensity Standard Smoking Cessation Treatment	Standard Telephone Counseling	2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)
Low-Intensity Standard Smoking Cessation Treatment	Mailed Information about Standard Care Resources	2 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	Cancer-Targeted Telephone Counseling	12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services
High-Intensity, Cancer-Targeted Smoking Cessation Treatment	Varenicline	12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services

Primary Outcome Measures

Name	Time	Method
Biochemically verified 7-day point-prevalence abstinence 26 weeks after a target quit date.	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 Outcome Measures

Name	Time	Method
Self-reported 7-day point-prevalence abstinence 12 weeks after a target quit date.	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?".

Trial Locations

Locations (1)

UW Carbone Cancer Center; 🇺🇸 Madison, Wisconsin, United States