Human-Centered Intervention for Lung Cancer Screening

(ELFE Trial)

Overseen By Neha Singh, B.S

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of California, Davis

Disqualifiers: Non-consenting, Non-English/Spanish, Under 50, Cancer, others

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

Compensation: Varies

Number of Visits: Unknown

2869 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to further understand the factors involved in increasing lung cancer screening.

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 Pre-Visit Planner, Pre-Visit Planner + MyChart for lung cancer screening?

The use of decision aids (tools to help patients make informed choices) in lung cancer screening has been shown to reduce patient uncertainty and improve understanding of screening benefits and risks. This suggests that similar tools, like the Pre-Visit Planner and MyChart, could help patients better understand and engage with their lung cancer screening process. ^{1 2 3 4 5}

Is the Human-Centered Intervention for Lung Cancer Screening safe for humans?

The research does not provide specific safety data for the Human-Centered Intervention for Lung Cancer Screening, but it does mention that lung cancer screening with low-dose computed tomography generally has few major complications, although there are potential harms like false-positive results and procedural complications. ^{6 7 8 9 10}

How does the Human-Centered Intervention for Lung Cancer Screening differ from other treatments for lung cancer?

The Human-Centered Intervention for Lung Cancer Screening is unique because it focuses on addressing the barriers to implementing lung cancer screening programs, such as patient-provider communication and logistical challenges, rather than being a direct medical treatment. This approach emphasizes individualized risk assessment, shared decision-making, and a multidisciplinary strategy to improve the effectiveness and accessibility of lung cancer screening. ^{8 11 12 13 14}

Eligibility Criteria

This trial is for patients aged 50-80 who are eligible for lung cancer screening, have a history of smoking, and receive care at specified UCDH clinics. It's also for UCDH primary care providers and staff. People under 49, non-UCDH staff, those already screened for lung cancer, non-consenting individuals or those not fluent in English or Spanish, and patients with existing cancer cannot join.

Inclusion Criteria

Patients who are eligible for lung cancer screening

I am a healthcare provider at UCDHS serving patients aged 50-80.

I am between 50-80 years old, have a history of smoking, and receive care at a specified UCDH clinic.

Exclusion Criteria

I am 49 years old or younger.

Non UCDHS primary care providers and clinic staff

UCDHS patients who have already received Lung Cancer Screening

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive a human-centered intervention to increase lung cancer screening, including verification of smoking history and educational video

156 weeks

Follow-up

Participants are monitored for the effectiveness of the intervention in increasing lung cancer screening

156 weeks

Treatment Details

Interventions

• Pre-Visit Planner
• Pre-Visit Planner + MyChart

Trial Overview The study aims to understand how to improve lung cancer screening rates by testing two approaches: a 'Pre-Visit Planner' tool alone versus the planner combined with 'MyChart', an electronic health record system. The effectiveness of these interventions in increasing screenings will be compared.

Participant Groups

Group I: Pre-Visit Planner (PVP) + MyChart Experimental Treatment 1 Intervention

A Licensed Vocational Nurse (LVN) will verify patient smoking history and calculate pack years with the patient over the phone. In addition, the patient will receive educational video through MyChart prior to an LVN calling.

Group II: Pre-Visit Planner (PVP) Experimental Treatment 1 Intervention

A Licensed Vocational Nurse (LVN) will verify patient smoking history and calculate pack years with the patient over the phone.

Group III: Usual Care Active Control 1 Intervention

Patients will receive usual care.

Who Is Running the Clinical Trial?

University of California, Davis

Lead Sponsor

Trials

958

Recruited

4,816,000+

Findings from Research

A single-page, paper-based encounter decision aid (EDA) used during shared decision-making visits for lung cancer screening significantly reduced patient decisional conflict, as indicated by a drop in the Decisional Conflict Scale score from 35.0 to 0.2 (p < 0.001).

While 28% of patients understood the mortality benefit of lung cancer screening after the visit, a much higher percentage (82%) grasped the frequency of abnormal screening results, highlighting the need for improved patient education on the mortality benefits of screening.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. Ito Fukunaga, M., Balwan, A., Janis, JA., et al.[2023]

In a study of 188 lung cancer screening patients, nearly half (47%) misidentified their follow-up recommendations, indicating a significant gap in patient understanding of screening results, particularly among those with lower education levels and higher Lung-RADS scores.

Despite the high rate of misidentification, incorrect understanding of follow-up recommendations did not correlate with lower adherence to follow-up, suggesting that other factors, such as provider communication, may play a more critical role in ensuring patients follow through with recommended screenings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Identification of Lung Cancer Screening Follow-Up Recommendations and the Association with Adherence. Triplette, M., Wenger, DS., Shahrir, S., et al.[2022]

In a study of 901 high-risk patients undergoing CT lung cancer screening, 85.7% adhered to radiologist follow-up recommendations, indicating that high adherence rates are achievable in clinical settings.

The main reasons for nonadherence included patient refusal for follow-up exams (66.7%) and difficulties in contacting patients (20.9%), highlighting areas for improvement in patient engagement and communication.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. Alshora, S., McKee, BJ., Regis, SM., et al.[2018]

Many patients diagnosed with pulmonary nodules experience significant distress due to inadequate communication about their condition, highlighting a gap in patient-clinician interactions.

The review emphasizes the need for improved communication strategies to help patients better understand the implications of their pulmonary nodules, which could reduce anxiety and improve patient-centered outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pulmonary Nodules: A Small Problem for Many, Severe Distress for Some, and How to Communicate About It. Slatore, CG., Wiener, RS.[2021]

A study of 438 individuals in Indiana revealed that sociodemographic factors such as race, geographic location, income, and health insurance significantly influence lung cancer screening behavior.

The research identified disparities in screening participation based on race and residence, highlighting the need for targeted outreach and educational programs to improve screening rates among underrepresented groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. Carter-Harris, L., Slaven, JE., Monahan, PO., et al.[2023]

A randomized controlled trial involving 225 patients showed that telephone-based navigation significantly helped identify and address barriers to lung cancer screening, with personal and provider-related issues being the most common.

Provider-related barriers decreased by 80% during the screening process, indicating that patient navigation can effectively improve access to lung cancer screening, especially among minority and underserved populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Assessing Barriers and Facilitators to Lung Cancer Screening: Initial Findings from a Patient Navigation Intervention. Lee, SJC., Lee, J., Zhu, H., et al.[2023]

In a study of 404 patients undergoing lung cancer screening, 26.7-38.0% were found to have inadequate or marginal health literacy, indicating a significant barrier to understanding screening processes.

The readability of online educational materials about lung cancer screening averaged a grade level of 10.6, which is much higher than the recommended 6th grade level, suggesting that these materials may not be accessible to many patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Lung cancer screening: assessment of health literacy and readability of online educational resources. Haas, K., Brillante, C., Sharp, L., et al.[2019]

Annual low-dose CT screening for lung cancer significantly reduces mortality in high-risk individuals, specifically those aged 55-74 with a smoking history of over 30 pack-years.

Effective lung cancer screening requires a comprehensive approach that includes personalized risk assessment, shared decision-making, and a multidisciplinary care team to manage potential risks like overdiagnosis and anxiety from indeterminate findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reviewing Lung Cancer Screening: The Who, Where, When, Why, and How. Bade, BC., Brasher, PB., Luna, BW., et al.[2019]

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 of 1509 participants from diverse backgrounds, lung cancer screening with low-dose CT detected and treated cancer in 2.8% of cases, demonstrating its efficacy in early detection.

The screening had a low false-positive rate of 9.2% and resulted in very few complications, but adherence to annual screening was notably poor, with only 18.7% of participants returning for follow-up in the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Quantifying Benefits and Harms of Lung Cancer Screening in an Underserved Population: Results From a Prospective Study. Erkmen, CP., Randhawa, S., Patterson, F., et al.[2023]

The U.S. Preventive Services Task Force recommends low-dose computed tomography for lung cancer screening in long-term smokers, highlighting its importance for early detection.

However, the implementation of lung cancer screening faces significant challenges, including patient and provider decision-making complexities, logistical issues, and sociopolitical barriers that need to be addressed for effective program development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Multilevel Barriers to the Successful Implementation of Lung Cancer Screening: Why Does It Have to Be So Hard? Carter-Harris, L., Gould, MK.[2022]

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]

A qualitative study involving 105 current smokers revealed that most participants were unaware of lung cancer screening tests, despite 34.3% meeting the eligibility criteria for screening according to the USPSTF.

Participants expressed a strong desire for lung cancer screening but faced barriers such as lack of knowledge, cultural beliefs, and healthcare system issues, highlighting the need for better educational resources to inform smokers about screening options.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A qualitative analysis of smokers' perceptions about lung cancer screening. Gressard, L., DeGroff, AS., Richards, TB., et al.[2018]

The United States Preventive Services Task Force supports low-dose computed tomography (CT) screening for early lung cancer detection, which could significantly lower lung cancer mortality rates.

Implementing a successful lung cancer screening program requires careful consideration of safety, quality, cost-effectiveness, and accessibility, particularly for high-risk individuals without symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Issues with implementing a high-quality lung cancer screening program. Mulshine, JL., D'Amico, TA.[2022]

References

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

Pilot Study of an Encounter Decision Aid for Lung Cancer Screening. [2023]

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

Patient Identification of Lung Cancer Screening Follow-Up Recommendations and the Association with Adherence. [2022]

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

Adherence to Radiology Recommendations in a Clinical CT Lung Screening Program. [2018]

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

Pulmonary Nodules: A Small Problem for Many, Severe Distress for Some, and How to Communicate About It. [2021]

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

Understanding lung cancer screening behavior: Racial, gender, and geographic differences among Indiana long-term smokers. [2023]

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

Assessing Barriers and Facilitators to Lung Cancer Screening: Initial Findings from a Patient Navigation Intervention. [2023]

7. England pubmed.ncbi.nlm.nih.gov

Lung cancer screening: assessment of health literacy and readability of online educational resources. [2019]

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

Reviewing Lung Cancer Screening: The Who, Where, When, Why, and How. [2019]

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

Quantifying Benefits and Harms of Lung Cancer Screening in an Underserved Population: Results From a Prospective Study. [2023]

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

Multilevel Barriers to the Successful Implementation of Lung Cancer Screening: Why Does It Have to Be So Hard? [2022]

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

A qualitative analysis of smokers' perceptions about lung cancer screening. [2018]

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

Issues with implementing a high-quality lung cancer screening program. [2022]