Smoking Cessation Methods for Cancer Patients

Recruiting in Palo Alto (17 mi)

Overseen by Danielle E McCarthy, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Waitlist Available

Sponsor: University of Wisconsin, Madison

No Placebo Group

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for adult cancer patients who were diagnosed within the last 3 years and are looking to quit smoking. It's not specified who can't join, but typically those with health conditions that may interfere with the treatment or assessment might be excluded.

Inclusion Criteria

Received care from a participating oncology clinic in the past year

I was diagnosed with cancer within the last 3 years.

Has a current tobacco use status

Exclusion Criteria

Suicide attempt in the past year

I understand the study procedures and risks involved.

No current suicidal ideation

Participant Groups

The study compares two smoking cessation methods: an enhanced treatment with varenicline pills and targeted coaching calls, versus a standard approach using nicotine patches and regular phone counseling. The goal is to see which method helps more people quit smoking after 26 weeks.

Group I: High-Intensity, Cancer-Targeted Smoking Cessation Treatment Experimental Treatment 3 Interventions

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

Group II: Low-Intensity Standard Smoking Cessation Treatment Active Control 3 Interventions

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

Varenicline is already approved in United States, European Union, Canada for the following indications:

🇺🇸 Approved in United States as Chantix for:

• Smoking cessation
• Dry eye disease

🇪🇺 Approved in European Union as Champix for:

• Smoking cessation

🇨🇦 Approved in Canada as Champix for:

• Smoking cessation

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

UW Carbone Cancer Center Madison, WI

Who Is Running the Clinical Trial?

University of Wisconsin, Madison Lead Sponsor

National Cancer Institute (NCI) Collaborator

References