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

NCT ID: NCT05627674

Last Updated: 2025-12-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

NA

Total Enrollment

915 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-01

Study Completion Date

2028-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Smoking Smoking Cessation Tobacco Use Cessation

Keywords

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precision prevention genetically-informed interventions lung cancer screening tobacco treatment risk feedback

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Usual Care

Annual 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.

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type BEHAVIORAL

Usual care incorporates guideline awareness and brief advice.

RiskProfile-Clin

RiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors.

Group Type EXPERIMENTAL

RiskProfile-Clin

Intervention Type BEHAVIORAL

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

RiskProfile-Gen

RiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors.

Group Type EXPERIMENTAL

RiskProfile-Gen

Intervention Type BEHAVIORAL

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

Interventions

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Usual Care

Usual care incorporates guideline awareness and brief advice.

Intervention Type BEHAVIORAL

RiskProfile-Clin

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

Intervention Type BEHAVIORAL

RiskProfile-Gen

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

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
* Current or former smokers
* Pack years ≥ 20
* English-speaking

Exclusion Criteria

PATIENTS:

* Lung cancer diagnosis
* Current order placed for lung cancer screening
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Washington University School of Medicine

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Alex Ramsey, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

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

Role: PRINCIPAL_INVESTIGATOR

Washington University School of Medicine

Locations

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Washington University School of Medicine

St Louis, Missouri, United States

Site Status

Countries

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United States

Related Links

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http://www.siteman.wustl.edu

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

Other Identifiers

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R01CA268030

Identifier Type: NIH

Identifier Source: secondary_id

View Link

202203081

Identifier Type: -

Identifier Source: org_study_id