Clinical trial NCT05627674: Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment
Official title: Precision Approaches to Lung Cancer Screening and Smoking Cessation Treatment in Primary Care
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Smoking
Smoking Cessation
Tobacco Use Cessation
Keywords: precision prevention
genetically-informed interventions
lung cancer screening
tobacco treatment
risk feedback
Lead sponsor: Washington University School of Medicine
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2022-11-28
Enrollment: 915
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

Brief 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. 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Clinician ordering of lung cancer screening
timeFrame: From enrollment through 6 months post-intervention
measure: Patient completion of lung cancer screening
timeFrame: From enrollment through 6 months post-intervention
Secondary outcomes:
measure: Clinician ordering of lung cancer screening
timeFrame: From enrollment through 18 months post-intervention
measure: Patient completion of lung cancer screening
timeFrame: From enrollment through 18 months post-intervention
measure: Patient completion of lung cancer screening, of those with order for screening
timeFrame: From enrollment through 18 months post-intervention
measure: Patient ongoing adherence to annual repeat lung cancer screening
timeFrame: From enrollment through 18 months post-intervention
measure: Clinician prescribing of tobacco treatment
timeFrame: From enrollment through 18 months post-intervention
measure: Patient use of tobacco treatment
timeFrame: From enrollment through 18 months post-intervention
measure: Readiness to quit smoking
timeFrame: From baseline through 18 months post-intervention
measure: Smoking heaviness
timeFrame: From baseline through 18 months post-intervention
measure: Smoking abstinence
timeFrame: From baseline through 18 months post-intervention
Other outcomes:
measure: Personal relevance (Patients)
timeFrame: From enrollment through 18 months post-intervention
measure: Perceived disease risk (Patients)
timeFrame: From baseline through 18 months post-intervention
measure: Perceived benefits of screening and treatment (Patients)
timeFrame: From baseline through 18 months post-intervention
measure: Perceived benefits of screening and treatment (Clinicians)
timeFrame: exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)
measure: Patient-centeredness of care discussions regarding screening and treatment (Patients)
timeFrame: From enrollment through 18 months post-intervention
measure: Patient-centeredness of care discussions regarding screening and treatment (Clinicians)
timeFrame: exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]
Locations:
city: Saint Louis
country: United States
facility: Washington University School of Medicine
state: Missouri
Study officials:
affiliation: Washington University School of Medicine
name: Alex Ramsey, Ph.D.
role: PRINCIPAL_INVESTIGATOR
affiliation: Washington University School of Medicine
name: Li-Shiun Chen, M.D., MPH, ScD
role: PRINCIPAL_INVESTIGATOR
References: