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Pharmacotherapy
High-Intensity, Cancer-Targeted Smoking Cessation Treatment for Smoking Cessation
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 30 weeks post target quit date
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
I was diagnosed with cancer within the last 3 years.
Select...
I do not have a cognitive impairment and do not have a health care power of attorney.
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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Biochemically verified 7-day point-prevalence abstinence 26 weeks after a target quit date.
Secondary outcome measures
Self-reported 7-day point-prevalence abstinence 12 weeks after a target quit date.
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
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)NIH
13,717 Previous Clinical Trials
40,953,314 Total Patients Enrolled
University of Wisconsin, MadisonLead Sponsor
1,193 Previous Clinical Trials
3,161,819 Total Patients Enrolled
Danielle E McCarthy, PhDPrincipal InvestigatorUniversity of Wisconsin, Madison
1 Previous Clinical Trials
13,000 Total Patients Enrolled
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