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Pharmacotherapy

Smoking Cessation Methods for Cancer Patients

Phase 4

Waitlist Available

Led By Danielle E McCarthy, PhD

Research Sponsored by University of Wisconsin, Madison

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosed with cancer in the past 3 years

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

Must not have

Unable to provide informed consent to treatment (i.e., cannot answer questions about study procedures or risks after hearing about the study)

Currently receiving treatment for bipolar disorder, schizophrenia, schizoaffective disorder, or psychotic disorder

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 30 weeks post target quit date

Awards & highlights

Drug Has Already Been Approved

No Placebo-Only Group

Pivotal Trial

Summary

This trial will compare two different ways to help cancer patients quit smoking. One group will receive 12 weeks of varenicline treatment and coaching calls focused on quitting smoking with cancer. The other group

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Varenicline may cause nausea, sleep problems, constipation, gas, or vomiting. Nicotine patches can lead to skin irritation at the patch site, dizziness, racing heartbeat or headaches.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I was diagnosed with cancer within the last 3 years.

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I do not have a cognitive impairment and do not have a health care power of attorney.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I understand the study procedures and risks involved.

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I am currently being treated for a serious mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 30 weeks post target quit date

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 30 weeks post target quit date

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 30 weeks post target quit date for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Biochemically verified 7-day point-prevalence abstinence 26 weeks after a target quit date.

Secondary study objectives

Self-reported 7-day point-prevalence abstinence 12 weeks after a target quit date.

Awards & Highlights

Drug Has Already Been Approved

The FDA has already approved this drug, and is just seeking more data.

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: High-Intensity, Cancer-Targeted Smoking Cessation TreatmentExperimental Treatment3 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 TreatmentActive Control3 Interventions

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Varenicline

2011

Completed Phase 4

~4170

0 / 4Eligibility criteria met