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

Primary Purpose

Smoking, Smoking Cessation, Tobacco Use Cessation

Status
Enrolling by invitation
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Usual Care
RiskProfile-Clin
RiskProfile-Gen
Sponsored by
Washington University School of Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Smoking focused on measuring precision prevention, genetically-informed interventions, lung cancer screening, tobacco treatment, risk feedback

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 Currently smoking or quit within past 15 years Cumulative pack years ≥ 20 English-speaking Exclusion Criteria: PATIENTS: Lung cancer diagnosis Current order placed for lung cancer screening Unsuccessful DNA sample analyses

Sites / Locations

  • Washington University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Usual Care

RiskProfile-Clin

RiskProfile-Gen

Arm Description

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.

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.
Patient completion of lung cancer screening
This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.
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.
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
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).
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).
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.
Smoking heaviness
This will be quantified by the average number of cigarettes smoked per day in the past 30 days.
Smoking abstinence
This will be quantified by a self-reported 7-day point prevalence.

Full Information

First Posted
November 2, 2022
Last Updated
October 20, 2023
Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05627674
Brief Title
Precision Prevention Strategy to Increase Uptake and Engagement in Lung Cancer Screening and Smoking Cessation Treatment
Acronym
PRECISE
Official Title
Precision Approaches to Lung Cancer Screening and Smoking Cessation Treatment in Primary Care
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
January 1, 2023 (Actual)
Primary Completion Date
January 31, 2026 (Anticipated)
Study Completion Date
January 31, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
Collaborators
National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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 90 clinicians and 825 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Smoking, Smoking Cessation, Tobacco Use Cessation
Keywords
precision prevention, genetically-informed interventions, lung cancer screening, tobacco treatment, risk feedback

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
None (Open Label)
Allocation
Randomized
Enrollment
915 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual Care
Arm Type
Active Comparator
Arm Description
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.
Arm Title
RiskProfile-Clin
Arm Type
Experimental
Arm Description
RiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Arm Title
RiskProfile-Gen
Arm Type
Experimental
Arm Description
RiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Usual Care
Intervention Description
Usual care incorporates guideline awareness and brief advice.
Intervention Type
Behavioral
Intervention Name(s)
RiskProfile-Clin
Intervention Description
RiskProfile-Clin incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors.
Intervention Type
Behavioral
Intervention Name(s)
RiskProfile-Gen
Intervention Description
RiskProfile-Gen incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors and genetic factors.
Primary Outcome Measure Information:
Title
Clinician ordering of lung cancer screening
Description
This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening.
Time Frame
From enrollment through 6 months post-intervention
Title
Patient completion of lung cancer screening
Description
This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.
Time Frame
From enrollment through 6 months post-intervention
Secondary Outcome Measure Information:
Title
Clinician ordering of lung cancer screening
Description
This will be quantified by the proportion of screen-eligible patients who receive a clinician order for lung cancer screening.
Time Frame
From enrollment through 18 months post-intervention
Title
Patient completion of lung cancer screening
Description
This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.
Time Frame
From enrollment through 18 months post-intervention
Title
Patient completion of lung cancer screening, of those with order for screening
Description
This will be quantified by the proportion of screen-eligible patients with an order for lung cancer screening who complete lung cancer screening.
Time Frame
From enrollment through 18 months post-intervention
Title
Patient ongoing adherence to annual repeat lung cancer screening
Description
This will be quantified by the proportion of screen-eligible patients who complete a repeat annual lung cancer screening
Time Frame
From enrollment through 18 months post-intervention
Title
Clinician prescribing of tobacco treatment
Description
This will be quantified by the proportion of screen-eligible current smokers who receive a clinician order for tobacco treatment (medication and/or counseling).
Time Frame
From enrollment through 18 months post-intervention
Title
Patient use of tobacco treatment
Description
This will be quantified by the proportion of screen-eligible current smokers who use tobacco treatment (medication and/or counseling).
Time Frame
From enrollment through 18 months post-intervention
Title
Readiness to quit smoking
Description
This will be quantified by the proportion of current smokers in the stage of change classifications of Precontemplation, Contemplation, Preparation, or Action.
Time Frame
From baseline through 18 months post-intervention
Title
Smoking heaviness
Description
This will be quantified by the average number of cigarettes smoked per day in the past 30 days.
Time Frame
From baseline through 18 months post-intervention
Title
Smoking abstinence
Description
This will be quantified by a self-reported 7-day point prevalence.
Time Frame
From baseline through 18 months post-intervention
Other Pre-specified Outcome Measures:
Title
Personal relevance (Patients)
Description
The relevance and importance of the intervention for informing the patient's health-related decision making will be assessed using a modified version of the Systematic Processing scale. This scale is measured on a 7-point Likert scale (1 = completely disagree; 7 = completely agree), with higher scores representing greater systematic processing and personal relevance.
Time Frame
From enrollment through 18 months post-intervention
Title
Perceived disease risk (Patients)
Description
Self-reported perceptions of smoking-related disease risks will be assessed using the Perceived Susceptibility and Severity subscales. Possible scores for the susceptibility subscale range from 1 (very unlikely) to 7 (very likely), and possible scores for the severity subscale range from 1 (not at all severe) to 5 (extremely severe), with higher scores representing greater perceived susceptibility and severity of disease.
Time Frame
From baseline through 18 months post-intervention
Title
Perceived benefits of screening and treatment (Patients)
Description
Patients' perceived importance and benefits of receiving lung cancer screening and smoking cessation medications will be assessed using a modified version of the Beliefs and Attitudes about Bupropion scale. The scale is measured on a 5-point Likert scale (1 = not at all; 5 = extremely), with higher scores representing greater perceived benefits of lung cancer screening and smoking cessation medications.
Time Frame
From baseline through 18 months post-intervention
Title
Perceived benefits of screening and treatment (Clinicians)
Description
Clinicians' perceived importance and benefits of eligible patients receiving lung cancer screening and smoking cessation medications will be assessed using a modified version of the Beliefs and Attitudes about Bupropion scale. The scale is measured on a 5-point Likert scales (1 = not at all; 5 = extremely), with higher scores representing greater perceived benefits of lung cancer screening and smoking cessation medications.
Time Frame
exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)
Title
Patient-centeredness of care discussions regarding screening and treatment (Patients)
Description
Patients' perceptions on the extent to which clinician-patient discussions focused on patient-specific needs, preferences, and information regarding lung cancer screening and tobacco treatment will be assessed using the Perceived Involvement in Care Scale (PICS). The scale is measured on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree), with higher scores representing greater patient-centeredness in care discussions.
Time Frame
From enrollment through 18 months post-intervention
Title
Patient-centeredness of care discussions regarding screening and treatment (Clinicians)
Description
Clinicians' perceptions on the extent to which clinician-patient discussions focused on patient-specific needs, preferences, and information regarding lung cancer screening and tobacco treatment will be assessed using the Perceived Involvement in Care Scale (PICS). The scale is measured on a 5-point Likert scale (1 = strongly disagree; 5 = strongly agree), with higher scores representing greater patient-centeredness in care discussions.
Time Frame
exit interview [after last patient is enrolled per clinician at the time of the last intervention (approximately 3 years)]

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 Currently smoking or quit within past 15 years Cumulative pack years ≥ 20 English-speaking Exclusion Criteria: PATIENTS: Lung cancer diagnosis Current order placed for lung cancer screening Unsuccessful DNA sample analyses
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alex Ramsey, Ph.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Li-Shiun Chen, M.D., MPH, ScD
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
The genotype data will be made available 12 months after trial completion in a NIH-designated data repository after data cleaning and quality control completion, which we anticipate to be in year 5, without restrictions on publication or other dissemination.
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

Learn more about this trial

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

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