Tobacco Treatment Comparison for Cancer Care

University of Wisconsin (UW)

Status and phase: Completed; Phase 4

Conditions: Cancer; Smoking Cessation

Treatments: Behavioral: Cancer-Targeted Telephone Counseling; Drug: Varenicline; Behavioral: Standard Telephone Counseling; Other: Mailed Information about Standard Care Resources; Drug: Transdermal Nicotine Patch

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06218823

2023-1025

SMPH/MEDICINE/GEN INT MD (Other Identifier)

UW23091 (Other Identifier)

Protocol Version 2/13/2024 (Other Identifier)

2P01CA180945-06 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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52 participants in 2 patient groups

Low-Intensity Standard Smoking Cessation Treatment

Active Comparator group

Description:

2 weeks of nicotine patch therapy, 3 telephone counseling sessions, and information about quitline and National Cancer Institute text messaging support services (SmokefreeTXT)

Treatment:

Drug: Transdermal Nicotine Patch

Other: Mailed Information about Standard Care Resources

Behavioral: Standard Telephone Counseling

High-Intensity, Cancer-Targeted Smoking Cessation Treatment

Experimental group

Description:

12 weeks of varenicline therapy, 7 counseling sessions targeted to cancer patients, and information about quitline and SmokefreeTXT services

Treatment:

Other: Mailed Information about Standard Care Resources

Drug: Varenicline

Behavioral: Cancer-Targeted Telephone Counseling