Lung Screening for Lung Cancer

Recruiting at 9 trial locations

Overseen By Francis Valenzona

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hackensack Meridian Health

Disqualifiers: Lung cancer, Prior lung screening, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 2

100 Participants Needed

Trial Summary

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 LungTalk, LungTalk Digital Tool, Lung Cancer Screening Communication Tool for lung cancer screening?

Research shows that tools like the Risk-Based NLST Outcomes Tool and patient education classes can help people understand their lung cancer risk and make better decisions about screening. These tools improve knowledge and decision-making, which are important for effective lung cancer screening. ^{1 2 3 4 5}

Is the LungTalk tool safe for use in humans?

The available research does not provide specific safety data for the LungTalk tool or its other names, but it is primarily a communication tool to increase awareness and knowledge about lung cancer screening, which suggests it is generally safe for use. ^{1 6 7 8 9}

How is the LungTalk treatment different from other lung cancer treatments?

LungTalk is unique because it is a digital communication tool designed to increase awareness and knowledge about lung cancer screening, particularly using social media to reach high-risk individuals who may not be aware of or have access to screening. Unlike traditional treatments that focus on medical interventions, LungTalk aims to improve patient understanding and participation in screening programs. ^{7 10 11 12 13}

What is the purpose of this trial?

This is a pilot Type 1 Hybrid Effectiveness-Implementation Trial. The study will first examine reach in a non-traditional setting (the Emergency Department - ED) that uses an Electronic Health Record (EHR)-embedded Social Determinants of Health (SDoH) screening tool to identify lung screening-eligible patients for a tailored intervention to increase lung screening uptake. Reach is defined as the absolute number, proportion, and representativeness of individuals targeted for lung screening knowledge, awareness, and uptake. Then, a pilot trial will be conducted to examine the preliminary effectiveness of a tailored lung screening intervention compared to enhanced usual care to influence individual-level potential drivers of lung screening (health literacy, mistrust, stigma, fatalism, knowledge, lung screening health beliefs) and the ability to increase lung screening uptake among screening-eligible patients. Quantitative (Randomized Controlled Trial and EHR data) methods will be used for data collection and analysis to address the study aims.

Research Team

Lisa Carter-Bawa, PhD

Principal Investigator

Hackensack Meridian Health

Eligibility Criteria

The LEAD Study is for individuals aged 50-80 who have a history of heavy smoking (at least 20 pack-years), are current smokers or quit within the last 15 years, and have never had lung cancer screening. Participants must be able to give informed consent and speak English.

Inclusion Criteria

I am between 50 and 80 years old.

I currently smoke or quit smoking within the last 15 years.

I can speak and understand English.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a tailored lung screening intervention using the LungTalk tool or a non-tailored pamphlet

1 month

1 visit (in-person) for intervention delivery

Follow-up

Participants are monitored for changes in lung cancer screening uptake and related health beliefs

6 months

Assessments at 1 week, 1 month, and 6 months post-intervention

Treatment Details

Interventions

• LungTalk

Trial Overview This study tests 'LungTalk', a tailored intervention to increase lung screening uptake, against non-tailored lung screening advice in the Emergency Department. It aims to see if personalized communication can improve knowledge and attitudes towards lung cancer screening.

Participant Groups

Group I: LungTalk Group Experimental Treatment 1 Intervention

LungTalk is a novel theoretically grounded health educational tool that will be delivered via iPad and is an interactive computer-based program that includes audio, video and animation segments with scripts presented from a master content library in consideration of different ways people like to learn. Informed by our prior research, LungTalk tailors its content based on smoking status and perceived barriers. In prior work, LungTalk more than doubled Lung Cancer Screening (LCS) knowledge and health beliefs (p \< 0.01), and was associated with a significant increase in deciding to screen for lung cancer compared to control group; OR 1.99; 95% CI, 1.03, 3.85, p = 0.03.

Group II: Non-tailored Lung Screening Pamphlet Group Active Control 1 Intervention

Non-tailored Lung Screening Pamphlet is a non-tailored educational brochure, What is Lung Cancer Screening from the GO2 Foundation that will be emailed to the patient. This widely used educational standard of care is a 2-page reader-friendly non-tailored electronic brochure about risk and screening for lung cancer used in clinical and community settings.

LungTalk is already approved in United States for the following indications:

Approved in United States as LungTalk for:

• Lung Cancer Screening Awareness
• Education and Support

Who Is Running the Clinical Trial?

Hackensack Meridian Health

Lead Sponsor

Trials

141

Recruited

42,900+

New Jersey Commission on Cancer Research

Collaborator

Trials

1

Recruited

100+

Findings from Research

The Risk-Based NLST Outcomes Tool (RNOT) helps individuals understand their personalized risk of lung cancer diagnosis and death, which can aid in making informed decisions about screening.

Participants in the study found the RNOT useful for screening decisions, although they expressed confusion about risk changes and indicated that there was no level of false-positive risk that would deter them from screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Perspectives on the Risk-Based NLST Outcomes Tool for Lung Cancer Screening. Roberts, MC., Seaman, EL., Klein, WMP., et al.[2022]

A group education class on lung cancer screening significantly improved participants' knowledge, with an average increase of 0.9 correct responses on a true-false quiz after the class, based on surveys from 680 participants.

Approximately 70% of participants felt they had enough information to make informed decisions about lung cancer screening after attending the class, indicating that this educational approach effectively enhances decision-making capacity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. Sakoda, LC., Meyer, MA., Chawla, N., et al.[2021]

A computer-tailored decision support tool has been developed to help patients engage in shared decision-making about lung cancer screening, with initial phases showing it is user-friendly and satisfactory for participants.

The ongoing pilot randomized controlled trial with 60 participants aims to assess the tool's effectiveness in improving knowledge, perceived risk, and self-efficacy regarding lung cancer screening, which could lead to better patient-clinician discussions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Usability Testing of a Computer-Tailored Decision Support Tool for Lung Cancer Screening: Study Protocol. Carter-Harris, L., Comer, RS., Goyal, A., et al.[2020]

The National Lung Screening Trial found that annual low-dose CT scans can reduce lung cancer-specific mortality by 20% in older heavy smokers, highlighting the potential effectiveness of lung cancer screening.

To maximize the benefits of lung cancer screening, ongoing research is essential for improving risk assessment, patient communication, and management of detected abnormalities, ensuring that screening programs are implemented responsibly.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening. Arenberg, D.[2015]

In a study of 1,060 adults participating in a lung cancer screening program, it was found that former smokers had a high perception of the effectiveness of screening, with 86.4% considering it beneficial for early disease detection.

The results indicated that both smokers and former smokers participated in lung screening at higher rates than non-smokers, suggesting that targeted communication strategies from general practitioners could further enhance participation among smokers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

First result of differentiated communication--to smokers and non-smokers--in order to increase the voluntary participation rate in lung screening. Moizs, M., Bajzik, G., Lelovics, Z., et al.[2021]

Lung cancer screening using low-dose chest CT scans can significantly reduce lung cancer mortality in a very high-risk group, highlighting its efficacy as a preventive measure.

Successful implementation of lung cancer screening programs requires addressing 11 identified obstacles, emphasizing the need for a multi-disciplinary approach and viewing screening as a comprehensive program rather than just a single test.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. Mazzone, PJ.[2018]

A randomized controlled trial is being conducted to evaluate the effectiveness of a social media-based intervention called LungTalk, aimed at increasing awareness and knowledge about lung cancer screening among high-risk individuals.

The study addresses the low uptake of lung cancer screening despite evidence from the National Lung Screening Trial showing that low-dose computed tomography can reduce lung cancer mortality, highlighting the potential of social media to reach underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leveraging social media to increase lung cancer screening awareness, knowledge and uptake among high-risk populations (The INSPIRE-Lung Study): Study protocol of design and methods of a community-based randomized controlled trial. Lisa, CB., Banerjee, SC., Ostroff, JS., et al.[2023]

In a study of 995 patients undergoing lung cancer screening with low-dose computed tomography (LDCT), 2.9% were diagnosed with lung cancer, indicating that screening can lead to early detection in a predominantly African American population.

The screening had a false-positive rate of 9.4%, with very few complications (0.7% from false-positive procedures), highlighting that while harms are rare, they need to be communicated effectively to patients, especially in underserved communities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. Lutzow, LK., Magarinos, J., Dass, C., et al.[2022]

Only 11% of reviewed NCI-Designated Cancer Center websites offered online lung cancer screening assessments, but most of these provided tailored recommendations based on national guidelines for lung cancer screening eligibility.

While the assessments encouraged patients to discuss their results with healthcare providers and highlighted the importance of a tobacco-free lifestyle, there is a need for more support to help patients effectively engage in shared decision-making conversations with their doctors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessment of Lung Cancer Screening Eligibility on NCI-Designated Cancer Center Websites. Paige, SR., Salloum, RG., Carter-Harris, L.[2022]

In a study involving 51 patients undergoing lung cancer screening, participants expressed high satisfaction with the information provided by clinicians, despite recalling few specific harms or benefits of the screening.

Patients reported a strong sense of trust in their clinicians and were generally satisfied with their role in the decision-making process, even though the communication did not fully align with the ideal of shared decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"I'm Putting My Trust in Their Hands": A Qualitative Study of Patients' Views on Clinician Initial Communication About Lung Cancer Screening. Golden, SE., Ono, SS., Thakurta, SG., et al.[2021]

A decentralized lung cancer screening program was successfully implemented across five primary care offices over three years, increasing access to screenings for patients in northeast Florida.

The program led to a higher percentage of early-stage lung cancers being detected, which significantly improved patient outcomes and survival rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening: Development and Replication of a Decentralized Program to Increase Access. Austin, C.[2021]

Four new scales were developed to measure health beliefs about lung cancer screening in long-term smokers, focusing on perceived risk, benefits, barriers, and self-efficacy, with input from experts and smokers.

Psychometric testing of these scales with 497 long-term smokers showed high reliability (Cronbach's α ranging from .88 to .92) and validity, indicating they can effectively identify smokers more likely to participate in lung cancer screening and inform future interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. Carter-Harris, L., Slaven, JE., Monohan, P., et al.[2018]

The NHS England leaflet for the Targeted Lung Health Check (TLHC) program was generally well-received by 40 current and former smokers aged 55-73, helping them understand the screening process and fostering positive intentions towards participation.

Participants expressed anxiety about potential screening results but felt reassured by the involvement of healthcare professionals; however, they struggled with understanding certain risks and eligibility criteria, indicating a need for clearer communication to support informed decision-making.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acceptability of a standalone written leaflet for the National Health Service for England Targeted Lung Health Check Programme: A concurrent, think-aloud study. Jallow, M., Black, G., van Os, S., et al.[2022]

References

1. England pubmed.ncbi.nlm.nih.gov

Patient Perspectives on the Risk-Based NLST Outcomes Tool for Lung Cancer Screening. [2022]

2. England pubmed.ncbi.nlm.nih.gov

Effectiveness of a Patient Education Class to Enhance Knowledge about Lung Cancer Screening: a Quality Improvement Evaluation. [2021]

3. Canada pubmed.ncbi.nlm.nih.gov

Development and Usability Testing of a Computer-Tailored Decision Support Tool for Lung Cancer Screening: Study Protocol. [2020]

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

Lung cancer screening. [2015]

5. England pubmed.ncbi.nlm.nih.gov

First result of differentiated communication--to smokers and non-smokers--in order to increase the voluntary participation rate in lung screening. [2021]

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

Obstacles to and Solutions for a Successful Lung Cancer Screening Program. [2018]

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

Leveraging social media to increase lung cancer screening awareness, knowledge and uptake among high-risk populations (The INSPIRE-Lung Study): Study protocol of design and methods of a community-based randomized controlled trial. [2023]

8. Netherlands pubmed.ncbi.nlm.nih.gov

Lung Cancer Screening in a Safety-Net Hospital: Rare Harms Inform Decision Making. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Assessment of Lung Cancer Screening Eligibility on NCI-Designated Cancer Center Websites. [2022]

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

"I'm Putting My Trust in Their Hands": A Qualitative Study of Patients' Views on Clinician Initial Communication About Lung Cancer Screening. [2021]

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

Lung Cancer Screening: Development and Replication of a Decentralized Program to Increase Access. [2021]

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

Development and Psychometric Evaluation of the Lung Cancer Screening Health Belief Scales. [2018]

13. England pubmed.ncbi.nlm.nih.gov

Acceptability of a standalone written leaflet for the National Health Service for England Targeted Lung Health Check Programme: A concurrent, think-aloud study. [2022]