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NCT Number: NCT07020273

CONNECT Cancer Survivors With Tobacco Treatment

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

Tobacco Use Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Nicotine Addiction Smoking Smoking Cessation Substance-Related Disorders Tobacco Smoking Tobacco Use Cessation Tobacco Use Disorder

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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).

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).

Primary outcomes

  1. 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)).

Secondary outcomes

  1. Patient receipt of tobacco use treatment - behavioral intervention.

    Time frame: Up to 6 months post-enrollment

    This will be quantified by the proportion of enrolled patients who receive tobacco use treatment behavioral intervention (brief advice or referral to counseling).

  2. Patient receipt of tobacco use treatment - medication.

    Time frame: Up to 6 months post-enrollment

    This will be quantified by the proportion of enrolled patients who receive tobacco use treatment medication.

  3. Patient smoking abstinence

    Time frame: Up to 6 months post-enrollment

    This will be quantified by the proportion of patients who smoke with EHR-documented smoking abstinence

Other outcomes

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

    Time frame: Up to 12 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).

  2. Patient receipt of tobacco use treatment - behavioral intervention.

    Time frame: Up to 12 months post-enrollment

    This will be quantified by the proportion of enrolled patients who receive tobacco use treatment behavioral intervention (brief advice or referral to counseling).

  3. Patient receipt of tobacco use treatment - medication.

    Time frame: Up to 12 months post-enrollment

    This will be quantified by the proportion of enrolled patients who receive tobacco use treatment medication.

  4. Patient smoking abstinence

    Time frame: Up to 12 months post-enrollment

    This will be quantified by the proportion of patients who smoke with EHR-documented smoking abstinence

  5. Patient bioverified smoking

    Time frame: Up to 12 months post-enrollment

    This will be quantified by the proportion of patients who smoke with bioverified point-prevalent abstinence.

Sponsors and collaborators

Lead sponsor

Washington University School of Medicine

Other

Registry information

Official study title

Cancer Prevention by Reducing Tobacco With Informatics and Chronic Care Approaches Trial (CONNECT)

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jun 13, 2025
Registry last updated
Jul 10, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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