Tobacco Treatment Comparison for Cancer Care

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.

Conditions

• Smoking Cessation
• Cancer

Interventions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• University of Wisconsin, Madison

  lead OTHER

Principal Investigators

• Danielle E McCarthy, PhD · University of Wisconsin, Madison

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-03-01

Primary Completion

2025-08-04

Completion

2025-08-04

FDA Drug

Yes

Countries

• United States

Study Locations