Tobacco UseNCT07020273
CONNECT Cancer Survivors With Tobacco Treatment
A study testing ELEVATE and ELEVATE-S in people with Tobacco Use and Tobacco Use Cessation, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the comparative effectiveness of two different informatics-enabled implementation strategies on increasing tobacco treatment and improving smoking cessation rates for cancer control and prevention. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tobacco Use, Tobacco Use Cessation, Smoking Cessation
- What is being tested?
- ELEVATE and ELEVATE-S
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,543 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jul 2025to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Eligibility Criteria:
- Be receiving care at a participating clinic
- Report current tobacco use (assessed by the rooming staff during the index visit)
- Have a completed appointment with a participating clinic
- Be an adult (at least 18 years old).
Trial locations and contacts
1 site in 1 country.
United States1 site
Washington University School of Medicine
St Louis, Missouri, 63110
About this study
Official title: Cancer Prevention by Reducing Tobacco With Informatics and Chronic Care Approaches Trial (CONNECT)
The purpose of this study is to evaluate the comparative effectiveness of two different informatics-enabled implementation strategies on increasing tobacco treatment and improving smoking cessation rates for cancer control and prevention. This will be done via a two-arm pragmatic cluster randomized trial (CRT) to test the effectiveness of nudges to change (ELEVATE-S) vs. quit-focused usual care (ELEVATE) in increasing tobacco treatment (use of medication, brief advice, or referral to external counseling) and smoking cessation.
- Conditions
- Tobacco Use, Tobacco Use Cessation, Smoking Cessation, Nicotine Addiction, Tobacco Smoking
- Being tested
- ELEVATE, ELEVATE-S
- Keywords
- Patient Reported Outcomes, Tobacco Treatment
- Medical subject headings
- Tobacco Use, Tobacco Use Cessation, Smoking Cessation, Tobacco Use Disorder, Tobacco Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELEVATEBehavioural
ELEVATE uses implementation strategies to support clinicians (support clinicians by revising professional roles to enable point of care tobacco treatment with a team are approach and support clinicians by providing clinical decision support tools).
ELEVATE-SBehavioural
ELEVATE-S uses implementation strategies to support clinicians (support clinicians by revising professional roles to enable point of care tobacco treatment with a team are approach and support clinicians by providing clinical decision support tools) and implementation strategies to support patients with chronic care model-informed self-management support (patient centered flexible goals and patient-generated health data).
| Study group | Role | What they receive |
|---|---|---|
| Electronic health record-enabled evidence-based tobacco treatment (ELEVATE) | Active comparator | Not described Receives: Behavioral: ELEVATE |
| Electronic health record-enabled evidence-based tobacco treatment-Support (ELEVATE-S) | Experimental | Not described Receives: Behavioral: ELEVATE-S |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach
This will be quantified by the proportion of enrolled patients who receive tobacco use treatment (either medication or behavioral intervention (brief advice or referral to counseling)).
Measured: Up to 6 months post-enrollment
Secondary outcomes (3)
Patient receipt of tobacco use treatment - behavioral intervention.
This will be quantified by the proportion of enrolled patients who receive tobacco use treatment behavioral intervention (brief advice or referral to counseling).
Measured: Up to 6 months post-enrollment
Patient receipt of tobacco use treatment - medication.
This will be quantified by the proportion of enrolled patients who receive tobacco use treatment medication.
Measured: Up to 6 months post-enrollment
Patient smoking abstinence
This will be quantified by the proportion of patients who smoke with EHR-documented smoking abstinence
Measured: Up to 6 months post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2025
- Study start1 Jul 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tobacco UseStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- 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
- Model description
- Randomization occurs at the clinic level. For pragmatic concerns, the investigators expect to recruit from multiple clinics and randomization will be stratified by department to minimize the clinic effect. Clinics will be randomized on a 1:1 basis to ELEVATE-S or ELEVATE. Patients within a clinic will be assigned to the same arm.
- Masking
- None (open label)
- Enrolment
- 3,543 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li-Shiun Chen, M.D., MPH, ScD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07020273
- Sponsor's protocol ID
- 202503025
- Status last verified
- Jul 2026
- First submitted
- 5 Jun 2025
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- 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 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cancer Prevention by Reducing Tobacco With Informatics and Chronic Care Approaches Trial (CONNECT)
- ClinicalTrials.gov ID
- NCT07020273
- Acronym / sponsor ID
- 202503025
- Conditions
- Tobacco Use, Tobacco Use Cessation, Smoking Cessation, Nicotine Addiction, Tobacco Smoking
- Keywords
- Patient Reported Outcomes, Tobacco Treatment
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 3,543 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 13 Jun 2025 (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.
The purpose of this study is to evaluate the comparative effectiveness of two different informatics-enabled implementation strategies on increasing tobacco treatment and improving smoking cessation rates for cancer control and prevention. This will be done via a two-arm pragmatic cluster randomized trial (CRT) to test the effectiveness of nudges to change (ELEVATE-S) vs. quit-focused usual care (ELEVATE) in increasing tobacco treatment (use of medication, brief advice, or referral to external counseling) and smoking cessation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomization occurs at the clinic level. For pragmatic concerns, the investigators expect to recruit from multiple clinics and randomization will be stratified by department to minimize the clinic effect. Clinics will be randomized on a 1:1 basis to ELEVATE-S or ELEVATE. Patients within a clinic will be assigned to the same arm.
| Arm | Type | Receives |
|---|---|---|
| Electronic health record-enabled evidence-based tobacco treatment (ELEVATE) | Active comparator | Behavioral: ELEVATE |
| Electronic health record-enabled evidence-based tobacco treatment-Support (ELEVATE-S) | Experimental | Behavioral: ELEVATE-S |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| ELEVATEELEVATE uses implementation strategies to support clinicians (support clinicians by revising professional roles to enable point of care tobacco treatment with a team are approach and support clinicians by providing clinical decision support tools). | Behavioural | Electronic health record-enabled evidence-based tobacco treatment (ELEVATE) |
| ELEVATE-SELEVATE-S uses implementation strategies to support clinicians (support clinicians by revising professional roles to enable point of care tobacco treatment with a team are approach and support clinicians by providing clinical decision support tools) and implementation strategies to support patients with chronic care model-informed self-management support (patient centered flexible goals and patient-generated health data). | Behavioural | Electronic health record-enabled evidence-based tobacco treatment-Support (ELEVATE-S) |
Primary outcome
Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach
Time frame: Up to 6 months post-enrollment
This will be quantified by the proportion of enrolled patients who receive tobacco use treatment (either medication or behavioral intervention (brief advice or referral to counseling)).
3 secondary outcomes
Patient receipt of tobacco use treatment - behavioral intervention.
Time frame: Up to 6 months post-enrollment
Patient receipt of tobacco use treatment - medication.
Time frame: Up to 6 months post-enrollment
Patient smoking abstinence
Time frame: Up to 6 months post-enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- 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.
Li-Shiun Chen, M.D., MPH, ScD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ELEVATE and ELEVATE-S in people with Tobacco Use and Tobacco Use Cessation, run by Washington University School of Medicine at 1 site 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?
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: under way, not looking for participants, as of the sponsor's last update on 10 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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?
Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach (time frame: Up to 6 months post-enrollment). 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 10 Jul 2026.