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.
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
- Type of treatment
- Lifestyle or therapy programme
- 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
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.
- Conditions
- Smoking, Smoking Cessation, Tobacco Use Cessation
- 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 group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | 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. Receives: Behavioral: Usual Care |
| RiskProfile-Clin | Experimental | RiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors. Receives: Behavioral: RiskProfile-Clin |
| RiskProfile-Gen | Experimental | RiskProfile-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.
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
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)
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
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
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
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
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
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
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
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
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.
- First posted28 Nov 2022
- Study start1 Jan 2023
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Alex Ramsey, Ph.D., Principal investigator, Washington University School of MedicineLi-Shiun Chen, M.D., MPH, ScD, Principal investigator, Washington University School of Medicine
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.
Study at a glance
From the registry record, last updated by the sponsor on 17 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Approaches to Lung Cancer Screening and Smoking Cessation Treatment in Primary Care
- ClinicalTrials.gov ID
- NCT05627674
- Acronym / sponsor ID
- PRECISE / 202203081
- Conditions
- Smoking, Smoking Cessation, Tobacco Use Cessation
- Keywords
- precision prevention, genetically-informed interventions, lung cancer screening, tobacco treatment, risk feedback
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 915 participants (estimated)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Aug 2028 (estimated)
- First posted
- 28 Nov 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Behavioral: Usual CareAnnual 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 | Experimental | Behavioral: RiskProfile-ClinRiskProfile-Clin is a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors. |
| RiskProfile-Gen | Experimental | Behavioral: RiskProfile-GenRiskProfile-Gen is a genetically-informed risk feedback tool to activate cancer risk-reducing behaviors. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Primary care clinician with active caseload in participating clinics
- Patient of participating primary care clinician
- Lung cancer screening naïve
- Between 50 to 80 years of age, inclusive
- Current or former smokers
Key exclusion criteria (3 listed)
- Lung cancer diagnosis
- Current order placed for lung cancer screening
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Usual CareUsual care incorporates guideline awareness and brief advice. | Behavioural | Usual Care |
| RiskProfile-ClinRiskProfile-Clin incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors. | Behavioural | RiskProfile-Clin |
| RiskProfile-GenRiskProfile-Gen incorporates standard brief advice and guideline awareness plus specific patient risk feedback using clinical factors and genetic factors. | Behavioural | RiskProfile-Gen |
Primary outcome
Clinician ordering of lung cancer screening
Time frame: From enrollment through 6 months post-intervention
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
Time frame: From enrollment through 6 months post-intervention
This will be quantified by the proportion of screen-eligible patients who complete lung cancer screening.
9 secondary outcomes
Clinician ordering of lung cancer screening
Time frame: From enrollment through 18 months post-intervention
Patient completion of lung cancer screening
Time frame: From enrollment through 18 months post-intervention
Patient completion of lung cancer screening, of those with order for screening
Time frame: From enrollment through 18 months post-intervention
Patient ongoing adherence to annual repeat lung cancer screening
Time frame: From enrollment through 18 months post-intervention
Clinician prescribing of tobacco treatment
Time frame: From enrollment through 18 months post-intervention
Patient use of tobacco treatment
Time frame: From enrollment through 18 months post-intervention
Readiness to quit smoking
Time frame: From baseline through 18 months post-intervention
Smoking heaviness
Time frame: From baseline through 18 months post-intervention
Smoking abstinence
Time frame: From baseline through 18 months post-intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Sep 2026.
- Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of MedicineLink provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Alex Ramsey, Ph.D. principal investigator
Washington University School of Medicine
Li-Shiun Chen, M.D., MPH, ScD principal investigator
Washington University School of Medicine
1 site in 1 country: see every site and its status.
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.