CONNECT Cancer Survivors With Tobacco Treatment

NCT07020273 | Recruiting

• 1 other identifier: 202503025
• Study Type: interventional
• Target: 5,000
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Patient Reported Outcomes; Tobacco Treatment

Outcome Measures

Primary Outcomes (1)

• 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)).

  Up to 6 months post-enrollment

Secondary Outcomes (3)

• Patient receipt of tobacco use treatment - behavioral intervention.

  Up to 6 months post-enrollment

• Patient receipt of tobacco use treatment - medication.

  Up to 6 months post-enrollment

• Patient smoking abstinence

  Up to 6 months post-enrollment

Other Outcomes (5)

• Patient receipt of tobacco use treatment, i.e. Tobacco use treatment (TUT) Reach

  Up to 12 months post-enrollment

• Patient receipt of tobacco use treatment - behavioral intervention.

  Up to 12 months post-enrollment

• Patient receipt of tobacco use treatment - medication.

  Up to 12 months post-enrollment

Study Arms (2)

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

Interventions

ELEVATE BEHAVIORAL

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).

Electronic health record-enabled evidence-based tobacco treatment (ELEVATE)

ELEVATE-S BEHAVIORAL

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).

Electronic health record-enabled evidence-based tobacco treatment-Support (ELEVATE-S)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

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).

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

RECRUITING

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Tobacco Use; Tobacco Use Cessation; Smoking Cessation; Tobacco Use Disorder; Tobacco Smoking

Condition Hierarchy (Ancestors)

Behavior; Health Behavior; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Smoking

Study Officials

• Li-Shiun Chen, M.D., MPH, ScD

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Li-Shiun Chen, M.D., MPH, ScD

CONTACT

314-362-3932; li-shiun@wustl.edu

Nina Smock

CONTACT

smockn@wustl.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 5, 2025
• First Posted: June 13, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): January 1, 2027
• Last Updated: January 8, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)