Personalized Risk Feedback for Lung Cancer Screening and Smoking Cessation

(PRECISE Trial)

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

915 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment RiskProfile-Clin, RiskProfile-Gen, Usual Care, Standard Care, Conventional Care for lung cancer screening and smoking cessation?

Research suggests that personalized messaging and feedback, like those used in RiskProfile-Clin and RiskProfile-Gen, can help people quit smoking, especially when they are already considering lung cancer screening. Additionally, using personal stories and decision aids, as seen in similar interventions, may enhance smoking cessation efforts. ^{1 2 3 4 5}

Is the Personalized Risk Feedback for Lung Cancer Screening and Smoking Cessation safe for humans?

The available research does not provide specific safety data for the Personalized Risk Feedback treatment, but it does focus on lung cancer screening and smoking cessation, which are generally considered safe practices when conducted under medical supervision. ^{1 3 6 7 8}

How does the treatment in the Personalized Risk Feedback for Lung Cancer Screening and Smoking Cessation trial differ from other treatments for smoking cessation?

This treatment is unique because it combines personalized feedback based on individual risk factors and screening results with smoking cessation support, which may include counseling and nicotine replacement therapy. This approach aims to tailor interventions to each person's specific needs and motivations, potentially increasing the effectiveness of smoking cessation efforts compared to standard treatments. ^{1 2 3 9 10}

Research Team

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

Principal Investigator

Washington University School of Medicine

Alex Ramsey, PhD

Principal Investigator

Washington University School of Medicine

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

Effect of a Personalized Tobacco Treatment Intervention on Smoking Abstinence in Individuals Eligible for Lung Cancer Screening. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Can nicotine replacement therapy be personalized? A statistical learning analysis. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

A risk-based framework for assessing real-time lung cancer screening eligibility that incorporates life expectancy and past screening findings. [2022]

4. United States 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. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Protocol for a randomized controlled trial of the Enhanced Smoking Cessation Approach to Promote Empowerment (ESCAPE) digitalized intervention to promote lung health in high-risk individuals who smoke. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Evaluation of Lung Cancer Risk Among Persons Undergoing Screening or Guideline-Concordant Monitoring of Lung Nodules in the Mississippi Delta. [2023]

7. England 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. [2023]

8. United States pubmed.ncbi.nlm.nih.gov

Prevalence And Impact of Medical Comorbidities in A Real-World Lung Cancer Screening Population. [2022]

9. Ireland pubmed.ncbi.nlm.nih.gov

Preliminary evaluation of a telephone-based smoking cessation intervention in the lung cancer screening setting: A randomized clinical trial. [2019]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Engaging Patients in Smoking Cessation Treatment within the Lung Cancer Screening Setting: Lessons Learned from an NCI SCALE Trial. [2022]