Personalized Risk Feedback for Lung Cancer Screening and Smoking Cessation

(PRECISE Trial)

Enrolling by invitation at 1 trial location

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Washington University School of Medicine

Disqualifiers: Lung cancer diagnosis, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 3

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how personalized risk feedback—one based on clinical information (RiskProfile-Clin) and another on genetic data (RiskProfile-Gen)—can influence lung cancer screening and smoking cessation efforts. The goal is to determine if these tools can encourage doctors to recommend, and patients to undergo, cancer screenings and quit smoking. The trial seeks current or former smokers aged 50 to 80 who have not had lung cancer screenings before and have smoked the equivalent of at least 20 years of a pack a day. Participants will be compared to those receiving standard care, which includes annual screenings and smoking cessation advice. As an unphased trial, this study provides a unique opportunity to contribute to innovative research that could enhance lung cancer prevention and smoking cessation strategies.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What prior data suggests that these risk feedback tools are safe for use in lung cancer screening and smoking cessation?

Research has shown that tools like RiskProfile-Clin and RiskProfile-Gen can aid in lung cancer screening and smoking cessation. These tools inform patients about their cancer risk and encourage healthier habits. No evidence of safety issues specifically related to these tools has been found in the sources.

This trial differs by focusing on behavior change rather than testing a new drug or procedure. As a result, the tools are likely easy to use and safe. They provide information to motivate better health choices, not treatments with possible side effects.

In summary, the tools are considered safe because they offer information rather than physical treatments. No negative effects specific to these tools have been reported in the sources. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores personalized risk feedback tools to enhance lung cancer screening and smoking cessation efforts. Unlike the usual care approach, which relies on standard annual screenings and tobacco cessation programs, the RiskProfile-Clin and RiskProfile-Gen tools offer tailored feedback. RiskProfile-Clin uses clinical data to provide personalized risk information, while RiskProfile-Gen leverages genetic information to do the same. These tools aim to empower individuals with specific insights into their cancer risk, potentially leading to more effective prevention and behavior change strategies.

What evidence suggests that this trial's treatments could be effective for lung cancer screening and smoking cessation?

In this trial, participants will be assigned to different arms to evaluate the effectiveness of personalized risk feedback tools. The RiskProfile-Clin arm uses a clinically-informed risk feedback tool to activate cancer risk-reducing behaviors. Previous studies suggest that tools like RiskProfile-Clin, which provide feedback based on medical information, can effectively encourage behaviors that lower cancer risk.

The RiskProfile-Gen arm involves a genetically-informed risk feedback tool. One study showed that personalized genetic information, as used in RiskProfile-Gen, was well-received by smokers and helped them take more steps to prevent cancer.

The Usual Care arm involves annual lung cancer screening with low-dose computed tomography (LDCT) and tobacco treatment and cessation for patients who smoke. Both RiskProfile tools aim to increase lung cancer screening and encourage quitting smoking, which is important for reducing lung cancer risk. Early evidence supports the potential effectiveness of these personalized feedback approaches in promoting preventive health actions. ^{2 4 6 7 8}

Who Is on the Research Team?

Alex Ramsey, PhD

Principal Investigator

Washington University School of Medicine

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

Principal Investigator

Washington University School of Medicine

Are You a Good Fit for This Trial?

This trial is for current smokers or those who quit within the last 15 years, aged 50-80, with a history of heavy smoking (≥20 pack-years), and have never been screened for lung cancer. Participants must be patients of clinicians in the study's clinics and speak English. Those already scheduled for lung cancer screening, diagnosed with lung cancer, or unable to provide a DNA sample are excluded.

Inclusion Criteria

Primary care clinician with active caseload in participating clinics

You are currently smoking or stopped smoking within the last 15 years.

You have not been screened for lung cancer before.

Exclusion Criteria

Current order placed for lung cancer screening

I have been diagnosed with lung cancer.

The analysis of your DNA sample was not successful.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive either usual care, clinically-informed RiskProfile, or genetically-informed RiskProfile to activate cancer risk-reducing behaviors

18 months

Initial intervention visit, followed by regular follow-ups

Follow-up

Participants are monitored for outcomes such as clinician ordering and patient completion of lung cancer screening, and tobacco treatment use

18 months

3-month, 6-month, 12-month, and 18-month post-intervention follow-ups

What Are the Treatments Tested in This Trial?

Interventions

• RiskProfile-Clin
• RiskProfile-Gen
• Usual Care

Trial Overview The trial examines two personalized risk feedback tools—clinically-informed (RiskProfile-Clin) and genetically-informed (RiskProfile-Gen)—against standard care. It aims to see if these tools affect how often doctors order lung cancer screenings/smoking cessation treatments and if their patients follow through.

How Is the Trial Designed?

Group I: RiskProfile-Gen Experimental Treatment 1 Intervention

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

Group II: RiskProfile-Clin Experimental Treatment 1 Intervention

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

Group III: Usual Care Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Washington University School of Medicine

Lead Sponsor

Trials

2,027

Recruited

2,353,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A pilot randomized trial involving 92 current smokers (average age 60.2 years) showed that telephone counseling (TC) for smoking cessation significantly increased quit rates to 17.4% compared to 4.3% in the usual care group, indicating the efficacy of TC in a lung cancer screening (LCS) setting.

The study demonstrated that TC is a feasible intervention, with participants completing an average of 4.4 counseling sessions, suggesting that integrating such programs into LCS could enhance public health efforts to reduce smoking among high-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial. Taylor, KL., Hagerman, CJ., Luta, G., et al.[2019]

In a study of 1358 patients undergoing lung cancer screening with low-dose computed tomography (LDCT), it was found that the average comorbidity burden was moderate, with chronic pulmonary disease being the most common condition.

Despite the presence of comorbidities, the completion rates for LDCT were not significantly affected by the Charlson Comorbidity Index, indicating that patients with various health issues can still successfully participate in lung cancer screening programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Prevalence And Impact of Medical Comorbidities in A Real-World Lung Cancer Screening Population. Majeed, H., Zhu, H., Williams, SA., et al.[2022]

The Personalised Lung Cancer Screening (PLuS) study aims to analyze the health conditions of around 40,000 individuals undergoing lung cancer screening with low-dose CT (LDCT) from 2016 to 2022, focusing on the comorbidity burden and the benefits and harms of screening.

This study is unique as it combines real-world observational data with simulation models to assess the long-term impact of lung cancer screening, which will help inform decision-making for older and potentially sicker populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Personalised Lung Cancer Screening (PLuS) study to assess the importance of coexisting chronic conditions to clinical practice and policy: protocol for a multicentre observational study. Braithwaite, D., Karanth, SD., Slatore, CG., et al.[2023]

In a study analyzing 33,077 participants in a smoking cessation program, the effectiveness of various types and doses of nicotine replacement therapy (NRT) did not significantly vary based on individual characteristics, suggesting a uniformity in treatment outcomes.

Both the main effects model and the model including interactions showed similar predictive accuracy for quit success, indicating that personalizing smoking cessation treatments based on participant demographics may not enhance effectiveness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Can nicotine replacement therapy be personalized? A statistical learning analysis. Veldhuizen, S., Zawertailo, L., Hussain, S., et al.[2022]

An online decision tool developed for advanced non-small-cell lung cancer significantly influenced treatment choices among 442 participating physicians, with expert feedback impacting decisions in 73% of cases.

The tool was particularly effective for cases involving ALK fusions, where participants were 2.5 times more likely to adopt expert-recommended therapies compared to cases with EGFR mutations, highlighting the importance of tailored treatment recommendations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Interactive On-line Tool on Therapeutic Decision-Making for Patients with Advanced Non-Small-Cell Lung Cancer. Chow, H., Edelman, MJ., Giaccone, G., et al.[2016]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4081623/

Impact of Lung Cancer Screening Results on Smoking ... This study evaluates the impact of lung cancer screening results on smoking cessation. Data from Lung Screening Study participants in the National ...

2. cancer.gov cancer.gov/news-events/cancer-currents-blog/2016/risk-profile-lung-screening

Risk Profiling May Improve Lung Cancer Screening - NCI The trial demonstrated a 20% reduction in lung cancer mortality among heavy smokers who received annual CT scans over 3 years, as compared with ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836784

CT Screening Interval for Patients at Moderate Risk of Lung ... Main Outcomes and Measures Strategy effectiveness was evaluated as lung cancer deaths prevented and life-years gained relative to annual ...

4. withpower.com withpower.com/trial/phase-lung-neoplasms-10-2022-8dcba

Personalized Risk Feedback for Lung Cancer Screening ... This trial tests the effects of two versions of RiskProfile, a clinically-informed and a genetically-informed version of a patient-specific risk feedback ...

5. ilcn.org ilcn.org/smoking-cessation-in-lung-cancer-screening-the-latest-randomized-controlled-trial-evidence/

Smoking Cessation in Lung Cancer Screening The SCALE trials aim to uncover key elements of successful smoking cessation programs by evaluating various intervention combinations.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5768904/

Lung Cancer Screening and Smoking Cessation Clinical ... This paper describes methodological issues related to the design of these clinical trials: clinical workflow, participant eligibility criteria, screening ...

7. academic.oup.com academic.oup.com/jnci/article/116/12/1896/7700735

risk and benefit profiles of US-eligible lung cancer screening ... We compared lung cancer death risk and life gained among USPSTF-eligible individuals by screening status (self-reported screened vs not screened ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1877782122000996

Association between lung cancer screening and smoking ... Receipt of lung cancer screening was associated with lower smoking rates and more frequent cessation attempts among US adults.