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Comprehensive Chronic Care for Smoking Cessation
N/A
Waitlist Available
Led By Michael Fiore, MD, MPH, MBA
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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 18 months
Awards & highlights
Study Summary
This trial will compare a new healthcare approach, Comprehensive Chronic Care, with the Standard of Care, to see if it is more effective in helping smokers quit, reaches more people, and is more cost effective.
Who is the study for?
This trial is for English-speaking primary care patients who are current daily smokers, listed on a smoking registry at a participating clinic or reported smoking during a clinic visit. They must understand the study and consent to participate. Those with cognitive impairments that prevent informed consent cannot join.Check my eligibility
What is being tested?
The Breathe 2 Project 3 compares Comprehensive Chronic Care (CCC), an approach aimed at increasing engagement in smoking treatment and abstinence, against Standard Care (SC). The study focuses on abstinence rates after 18 months, reach of treatment, and cost-effectiveness.See study design
What are the potential side effects?
Since this trial involves healthcare treatment approaches rather than medication, traditional side effects are not applicable. However, participants may experience stress or discomfort related to changes in their smoking habits.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months
Secondary outcome measures
Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)
Group differences in Cessation Treatment
Number of Participants with 7-day point-prevalence abstinence at 12 months
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Comprehensive Chronic CareExperimental Treatment1 Intervention
ongoing proactive outreach designed to provide support and information about evidence-based smoking treatment, with access to individually validated treatments that are appropriate for patients who are: 1) unwilling quit but willing to reduce; 2) ready to quit; and 3) recovering from an unsuccessful quit attempt
Group II: Standard CareActive Control1 Intervention
involves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually
Find a Location
Who is running the clinical trial?
University of Wisconsin, MadisonLead Sponsor
1,182 Previous Clinical Trials
3,166,387 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,657 Previous Clinical Trials
40,932,667 Total Patients Enrolled
Michael Fiore, MD, MPH, MBAPrincipal InvestigatorUW Center of Tobacco Research and Intervention
1 Previous Clinical Trials
14,930 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I understand the study and agree to participate.I have someone legally designated to make healthcare decisions for me, or I am not able to understand and give consent due to cognitive impairment.
Research Study Groups:
This trial has the following groups:- Group 1: Standard Care
- Group 2: Comprehensive Chronic Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Could you provide an update on the enrollment status of this clinical trial?
"Clinicaltrials.gov indicates that this medical trial which was initially posted on August 8th, 2022 is now closed for recruitment. Nevertheless, there are still 144 other trials open to new participants at the current time."
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