Smoking CessationNCT05382221
Breathe 2 Project 3: Comprehensive Chronic Care
A study testing Comprehensive Chronic Care in people with Smoking Cessation and Smoking Abstinence, run by University of Wisconsin, Madison at 2 sites in United States.
Trial summary
This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Smoking Cessation, Smoking Abstinence
- What is being tested?
- Comprehensive Chronic Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 979 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Aug 2022to 25 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- On smoking registry at a participating clinic OR report current smoking at a clinic visit
- Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
- Able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent)
- Able to speak and read English.
Who cannot join
- Activated healthcare power of attorney or cognitive impairment that would preclude informed consent.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
UW Health
Madison, Wisconsin, 53792
Advocate Aurora
Milwaukee, Wisconsin, 53204
About this study
This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.
Read the detailed description
This project is a 2-arm randomized controlled trial (RCT) designed to evaluate whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), increases smoking abstinence and treatment use in primary care patients who smoke. The aims are as follows:
- Primary Aim
- Aim 1: To determine whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), significantly improves biochemically confirmed 7-day point-prevalence smoking abstinence at 18 months post-enrollment.
- Secondary Aims
- Aim 2: To determine the effects of CCC relative to SC on: cost-effectiveness and 7-day point-prevalence smoking abstinence at 6- and 12-months (biochemically confirmed) post-enrollment.
- Aim 3: To compare CCC with SC on cessation treatment use over 18 months of treatment access.
Comprehensive Chronic Care (CCC) provides 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.
Standard Care (SC) involves one offer of cessation treatment per year (8 weeks of nicotine patch plus referral to the tobacco quit line).
- Conditions
- Smoking Cessation, Smoking Abstinence
- Being tested
- Comprehensive Chronic Care, Standard Care
- Keywords
- Chronic Care Tobacco Treatment, Standard of Care, Reduction Treatment, Motivation Phase Treatment
- Medical subject headings
- Smoking Cessation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive Chronic CareOther
Those randomized to CCC will receive smoking treatment offers via the following routes: 1) Four Outreach Calls from a Health Counselor at 4, 8, 12, and 14 months post-study enrollment; 2) Four texts and/or mailings (depending on healthcare system preferences) over 14 months. These outreach contacts will offer cessation treatment or reduction treatment.
Standard CareOther
one offer of cessation treatment annually
| Study group | Role | What they receive |
|---|---|---|
| Comprehensive Chronic Care | Experimental | 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 Receives: Other: Comprehensive Chronic Care |
| Standard Care | Active comparator | involves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually Receives: Other: Standard Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months
Group differences in abstinence at 18 months will be evaluated using logistic regression.
Measured: up to 18 months
Secondary outcomes (5)
Number of Participants with 7-day point-prevalence abstinence at 6 months
At 6 months, participants will be asked whether they have smoked in the past 7 days
Measured: 6 months
Number of Participants with 7-day point-prevalence abstinence at 12 months
At 12 months, participants will be asked whether they have smoked in the past 7 days
Measured: 12 months
Group differences in Cessation Treatment
Group differences in cessation treatment use will be evaluated using logistic regression analysis. Initiating greater than 0 Cessation calls will be coded as binary (use vs. no use).
Measured: Up to 18 months
Total Cost of Intervention
Incremental resource costs related to the CCC intervention include Health Counselor/staff time, administration, staff training, recruitment, and medication. Methods recommended by the United States Panel on Cost-Effectiveness in Health and Medicine will be utilized. Costs will be measured from a societal perspective using direct observational data of health system resource use. Cost estimates will be converted to a common year.
Measured: Up to 18 months
Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)
Cost per additional person who quits smoking, for the CCC vs. SC. The ICER is calculated as the difference in total costs between CCC and SC divided by the difference in 18-month quit rates.
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2022
- Study start8 Aug 2022
- Primary completion25 Sep 2025
- Study completion25 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking CessationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 979 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Jessica Cook, PhD, Principal investigator, UW Center of Tobacco Research and Intervention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05382221
- Sponsor's protocol ID
- 2022-0124
- Other IDs
- Protocol Version 10/12/2023, A534253, 2P01CA180945-06
- Status last verified
- Dec 2025
- First submitted
- 16 May 2022
- Last updated
- 18 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breathe 2 Project 3: Comprehensive Chronic Care
- ClinicalTrials.gov ID
- NCT05382221
- Acronym / sponsor ID
- 2022-0124
- Conditions
- Smoking Cessation, Smoking Abstinence
- Keywords
- Chronic Care Tobacco Treatment, Standard of Care, Reduction Treatment, Motivation Phase Treatment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 979 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 8 Aug 2022 (actual)
- Primary completion
- 25 Sep 2025 (actual)
- Study completion
- 25 Sep 2025 (actual)
- First posted
- 19 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will evaluate Comprehensive Chronic Care (CCC), a healthcare treatment approach designed to increase smoking treatment engagement and abstinence among primary care patients who smoke. This research will compare CCC with Standard of Care (SC) on the following outcomes: abstinence at 18 months (primary outcome), treatment reach, and cost-effectiveness. Participation in the study will last 18 months.
Detailed description
This project is a 2-arm randomized controlled trial (RCT) designed to evaluate whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), increases smoking abstinence and treatment use in primary care patients who smoke. The aims are as follows:
- Primary Aim
- Aim 1: To determine whether Comprehensive Chronic Care (CCC), relative to Standard Care (SC), significantly improves biochemically confirmed 7-day point-prevalence smoking abstinence at 18 months post-enrollment.
- Secondary Aims
- Aim 2: To determine the effects of CCC relative to SC on: cost-effectiveness and 7-day point-prevalence smoking abstinence at 6- and 12-months (biochemically confirmed) post-enrollment.
- Aim 3: To compare CCC with SC on cessation treatment use over 18 months of treatment access.
Comprehensive Chronic Care (CCC) provides 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.
Standard Care (SC) involves one offer of cessation treatment per year (8 weeks of nicotine patch plus referral to the tobacco quit line).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Comprehensive Chronic Care | Experimental | Other: Comprehensive Chronic Careongoing 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 |
| Standard Care | Active comparator | Other: Standard Careinvolves one offer of cessation treatment (8 weeks of nicotine patch plus referral to the tobacco quit line), annually |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- On smoking registry at a participating clinic OR report current smoking at a clinic visit
- Smoked cigarettes every day in the past 30 days (with or without other forms of tobacco or nicotine)
- Able to participate in informed consent activities (e.g., reports understanding the nature of the study and consent)
- Able to speak and read English.
Key exclusion criteria (1 listed)
- Activated healthcare power of attorney or cognitive impairment that would preclude informed consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive Chronic CareThose randomized to CCC will receive smoking treatment offers via the following routes: 1) Four Outreach Calls from a Health Counselor at 4, 8, 12, and 14 months post-study enrollment; 2) Four texts and/or mailings (depending on healthcare system preferences) over 14 months. These outreach contacts will offer cessation treatment or reduction treatment. | Other | Comprehensive Chronic Care |
| Standard Careone offer of cessation treatment annually | Other | Standard Care |
Primary outcome
Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months
Time frame: up to 18 months
Group differences in abstinence at 18 months will be evaluated using logistic regression.
5 secondary outcomes
Number of Participants with 7-day point-prevalence abstinence at 6 months
Time frame: 6 months
Number of Participants with 7-day point-prevalence abstinence at 12 months
Time frame: 12 months
Group differences in Cessation Treatment
Time frame: Up to 18 months
Total Cost of Intervention
Time frame: Up to 18 months
Cost Effectiveness measured by incremental cost-effectiveness ratio (ICER)
Time frame: Up to 18 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jessica Cook, PhD principal investigator
UW Center of Tobacco Research and Intervention
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comprehensive Chronic Care in people with Smoking Cessation and Smoking Abstinence, run by University of Wisconsin, Madison at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants with biochemically confirmed point-prevalence abstinence at 18 months (time frame: up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.