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SmokingPRECISENCT05627674

Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment

A study testing RiskProfile-Clin and RiskProfile-Gen in people with Smoking and Smoking Cessation, run by Washington University School of Medicine at 1 site in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
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Trial summary

This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Smoking, Smoking Cessation, Tobacco Use Cessation
What is being tested?
RiskProfile-Clin and RiskProfile-Gen
Could I receive a placebo?
No, everyone receives an active treatment
How many people
915 participants
Where
1 siteUnited States
Study dates
1 Jan 2023to 31 Aug 2028
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
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • CLINICIANS:
  • Primary care clinician with active caseload in participating clinics
  • PATIENTS:
  • Patient of participating primary care clinician
  • Lung cancer screening naïve
  • Between 50 to 80 years of age, inclusive
Show all 9Show fewer
  • Current or former smokers
  • Pack years ≥ 20
  • English-speaking

Who cannot join

  • PATIENTS:
  • Lung cancer diagnosis
  • Current order placed for lung cancer screening

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

United States1 site
  • Washington University School of Medicine

    St Louis, Missouri, 63110

Other trials in United States

About this study

Official title: Precision Approaches to Lung Cancer Screening and Smoking Cessation Treatment in Primary Care

This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback tool, in comparison to usual care, on lung cancer screening and tobacco treatment. The trial assesses the multilevel effects of these precision risk feedback tools on the likelihood of clinicians to order lung cancer screening and tobacco treatment and of their patients to utilize these cancer prevention interventions.

Read the detailed description

The overarching goal of this study is to test the impact of a precision risk feedback tool aiming to address gaps in clinician and patient uptake of lung cancer screening and tobacco treatment. This study builds on evidence that (1) clinical and genetic factors may inform precision risk on lung cancer and smoking cessation and (2) increasingly high demand for personal genetic risk in particular may signal its potential to activate behavior change. The multi-level precision prevention intervention to be tested--RiskProfile-- provides the opportunity to present personalized clinical and genetic information to increase clinician ordering and patient uptake of screening and treatment recommendations. This study aims to understand the relative benefit of a clinically-informed RiskProfile (based on clinical factors) over usual care, and the additional benefit of a genetically-informed RiskProfile (based on clinical and genetic factors) over the other intervention arms. Therefore, the investigators propose a 3-arm cluster randomized controlled trial of 141 clinicians and 705 screen-eligible patients from a diverse primary care setting (62% African American). Clinicians and patients will be randomized with 1:1:1 allocation to usual care vs. clinically-informed RiskProfile vs. genetically-informed RiskProfile to evaluate the effect of precision prevention interventions on screening and treatment. In Aim 1, the investigators will test the effect of RiskProfile on clinician orders for lung cancer screening and tobacco treatment. In Aim 2, the investigators will test the effect of RiskProfile on patient uptake of lung cancer screening and tobacco treatment. The investigators hypothesize that, compared to usual care, the outcomes of clinician ordering and patient receipt of screening and treatment will be higher in both RiskProfile groups and will be highest in the genetically-informed RiskProfile group. In Aim 3, the investigators will examine the effects of RiskProfile on potential mechanisms that may lead to increased uptake of lung cancer screening and tobacco treatment. The investigators hypothesize that RiskProfile will impact clinician perceptions about lung cancer screening and tobacco treatment that will, in turn, increase ordering behaviors. The investigators further hypothesize that these increases in clinician ordering, combined with changes in patient-level social-cognitive and engagement mechanisms, will increase lung cancer screening and tobacco treatment use among patients. The investigators will assess outcomes at enrollment (at the initial intervention visit), and at 3-month, 6-month, 12-month, and 18-month post-intervention follow-ups. Primary outcomes include clinician ordering and patient completion of lung cancer screening. Secondary outcomes include clinician prescribing and patient use of tobacco treatment, patient progress toward smoking cessation, and patient ongoing adherence to lung cancer screening. Mechanistic outcomes include patient social-cognitive and engagement factors, clinician perceptions about lung cancer screening and tobacco treatment, and clinician-patient interactions at the primary care visit. To better understand potential mechanistic influences of RiskProfile, the investigators will conduct qualitative semi-structured interviews with a subset of clinicians and patients, focused on decision-making processes as well as implementation barriers and facilitators for ordering and receiving lung cancer screening and tobacco treatment. At the nexus of primary care and lung cancer screening, this study will demonstrate the impact of this multi-level intervention designed to stimulate use of evidence-based and guideline-concordant care among primary care clinicians and racially-diverse, medically underserved patients at risk for lung cancer.

Being tested
Usual Care, RiskProfile-Clin, RiskProfile-Gen
Keywords
precision prevention, genetically-informed interventions, lung cancer screening, tobacco treatment, risk feedback
Medical subject headings
Smoking, Smoking Cessation, Tobacco Use Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Usual CareBehavioural

    Usual care incorporates guideline awareness and brief advice.

  • RiskProfile-ClinBehavioural

    RiskProfile-Clin incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors.

  • RiskProfile-GenBehavioural

    RiskProfile-Gen incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors and genetic factors.

Study groups in NCT05627674
Study groupRoleWhat they receive
Usual CareActive comparatorAnnual lung cancer screening with low-dose computed tomography (LDCT) is currently recommended in the U.S. for at-risk patients. Tobacco treatment and cessation is recommended for patients who smoke.
Receives: Behavioral: Usual Care
RiskProfile-ClinExperimentalRiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Receives: Behavioral: RiskProfile-Clin
RiskProfile-GenExperimentalRiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Receives: Behavioral: RiskProfile-Gen

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Clinician ordering of lung cancer screening

    This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening.

    Measured: From enrollment through 6 months post-intervention

  2. Patient completion of lung cancer screening

    This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.

    Measured: From enrollment through 6 months post-intervention

Secondary outcomes (9)
  1. Clinician ordering of lung cancer screening

    This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening.

    Measured: From enrollment through 18 months post-intervention

  2. Patient completion of lung cancer screening

    This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.

    Measured: From enrollment through 18 months post-intervention

  3. Patient completion of lung cancer screening, of those with order for screening

    This will be quantified by the proportion of screen-eligible patients with an order for lung cancer screening who complete lung cancer screening.

    Measured: From enrollment through 18 months post-intervention

  4. Patient ongoing adherence to annual repeat lung cancer screening

    This will be quantified by the proportion of screen-eligible patients who complete a repeat annual lung cancer screening

    Measured: From enrollment through 18 months post-intervention

  5. Clinician prescribing of tobacco treatment

    This will be quantified by the proportion of screen-eligible current smokers who receive a clinician order for tobacco treatment (medication and/or counseling).

    Measured: From enrollment through 18 months post-intervention

  6. Patient use of tobacco treatment

    This will be quantified by the proportion of screen-eligible current smokers who use tobacco treatment (medication and/or counseling).

    Measured: From enrollment through 18 months post-intervention

  7. Readiness to quit smoking

    This will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action.

    Measured: From baseline through 18 months post-intervention

  8. Smoking heaviness

    This will be quantified by the average number of cigarettes smoked per day in the past 30 days.

    Measured: From baseline through 18 months post-intervention

  9. Smoking abstinence

    This will be quantified by a self-reported 7-day point prevalence.

    Measured: From baseline through 18 months post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Nov 2022
  2. Study start1 Jan 2023
  3. Primary completion31 Aug 2027 (estimated)
  4. Study completion31 Aug 2028 (estimated)

Resources

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Model description
Clinicians will be randomized on a 1:1:1 basis to usual care, RiskProfile-Clin, or RiskProfile-Gen. Patients will be assigned to the same arm as their clinician.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
915 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05627674
Sponsor's protocol ID
202203081
Other IDs
R01CA268030
Acronym
PRECISE
Status last verified
Sep 2026
First submitted
2 Nov 2022
Last updated
17 Sep 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: The University will share anonymized human genomic data and relevant associated data from approximately 825 research participants by depositing these data in a NIH-designated data repository or other repositories that meet the appropriate data security measures, confidentiality, privacy, and data use measures. In addition, information necessary to interpret the submitted data will be included, such as study protocols, data instruments and survey tools.

Questions about this trial

What is this clinical trial studying?

A study testing RiskProfile-Clin and RiskProfile-Gen in people with Smoking and Smoking 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?

The sponsor lists 9 inclusion and 3 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: enrolling by invitation, as of the sponsor's last update on 17 Sep 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?

Clinician ordering of lung cancer screening (time frame: From enrollment through 6 months post-intervention). The study lists 2 primary outcomes in all. 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 17 Sep 2026.

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