Health Education & Support for Lung Cancer

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Jonsson Comprehensive Cancer Center

Disqualifiers: Lung cancer, Hemoptysis, Active cancer, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

800 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if advocates (supporters) can boost lung cancer screening rates by helping people overcome fears and lack of awareness about the process. Researchers are examining how education and support can make a difference, especially compared to the more commonly accepted breast cancer screenings. Participants will use an electronic portal for educational materials and access a patient navigator for guidance. The trial seeks current or former smokers, or those with a close family member or friend with a smoking history. The promoted screening method is the Low-Dose CT Scan (Computed Tomography Scan for Lung Cancer Screening).

As an unphased trial, this study offers a unique opportunity to contribute to understanding how advocacy and education can improve lung cancer screening rates.

Do I need to stop my current medications for this trial?

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

What prior data suggests that this method is safe for increasing lung cancer screening rates?

Research has shown that a low-dose CT scan (LDCT) serves as a safe tool for lung cancer screening. This scan uses less radiation than regular CT scans, reducing potential risks. Studies have found that LDCT screening can significantly lower the risk of dying from lung cancer in high-risk individuals. The U.S. Preventive Services Task Force recommends it for certain adults, indicating trust in its safety.

In this trial, participants will use educational materials and work with a patient navigator. As this approach focuses on learning and support rather than a medical procedure, it involves no physical risks. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it focuses on a novel approach to increasing lung cancer screening rates through education and support. Unlike traditional methods, which often rely solely on direct patient-doctor interactions, this approach leverages an electronic patient portal filled with educational materials and involves patient navigators who provide guidance and support. This method also encourages participants to engage their friends and family by sharing materials, potentially broadening awareness and understanding of the benefits of lung cancer screening. By emphasizing education and community support, this approach aims to enhance screening rates and early detection, ultimately improving patient outcomes.

What evidence suggests that utilizing advocates and supporters is effective for increasing lung cancer screening rates?

Research has shown that low-dose CT scans for lung cancer screening can significantly reduce lung cancer deaths. One study found a 20% decrease in lung cancer deaths over 6.5 years with this screening method. Another review confirmed that low-dose CT scans effectively detect lung cancer early, allowing treatment to begin when it is more likely to succeed. These scans accurately identify individuals with the disease, boasting a 97% accuracy rate. This evidence underscores the potential of low-dose CT scans to save lives by detecting lung cancer early. Participants in this trial will access an electronic patient portal with educational materials and interact with a patient navigator to support increased lung cancer screening rates. ^{4 6 7 8 9}

Who Is on the Research Team?

Ashley E. Prosper

Principal Investigator

UCLA / Jonsson Comprehensive Cancer Center

Are You a Good Fit for This Trial?

This trial is for people eligible for breast (over 40 years old) and lung cancer screening (ages 50-80), regardless of smoking status. Participants can be male or female and should have a close family or friend with a history of smoking. It excludes those under the age limits, previously diagnosed with lung cancer, recent unexplained weight loss, hemoptysis, or active cancer.

Inclusion Criteria

I am either male or female.

I am over 40 and have had a breast screening.

I am between 50 and 80 years old.

Exclusion Criteria

I am under 40 and have had a breast screening.

I am younger than 50 or older than 80.

I have not had lung cancer, coughed up blood, or lost more than 15 pounds without trying in the last year.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants access an electronic patient portal with educational materials and interact with a patient navigator. They also receive materials to share with friends and family on the benefits of breast and lung cancer screening.

2 years

Baseline, 1-year, and 2-year follow-ups

Follow-up

Participants are monitored for increased rates of lung and breast cancer screening adherence and the success of the 'sphere of influence' model.

Up to 3 years

What Are the Treatments Tested in This Trial?

Interventions

• Utilizing Advocates and Supporters to Increase Lung Cancer Screening Rates in Eligible Participants

Trial Overview The study tests if using advocates and supporters can increase lung cancer screening rates among eligible individuals. It involves health education programs, patient navigation services to guide through healthcare systems, and survey administration to gather data on psychological barriers unique to lung screening.

How Is the Trial Designed?

Group I: Screening (electronic patient portal, patient navigation) Experimental Treatment 4 Interventions

Participants access an electronic patient portal with educational materials at baseline, 1- and 2-year follow-ups, and also interact with a patient navigator on study. Patients also receive materials to share with their friends/family on benefits of breast and lung cancer screening on study.

Who Is Running the Clinical Trial?

Jonsson Comprehensive Cancer Center

Lead Sponsor

Trials

373

Recruited

35,200+

Published Research Related to This Trial

Annual low-radiation-dose computed tomography (LDCT) screening can significantly reduce lung cancer mortality in high-risk individuals, but its implementation requires careful planning to maximize benefits and minimize harms.

The American Thoracic Society and American College of Chest Physicians provide a framework for developing LDCT screening programs, outlining essential strategies for planning, implementation, and maintenance to ensure these programs are safe, effective, and sustainable.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An official American Thoracic Society/American College of Chest Physicians policy statement: implementation of low-dose computed tomography lung cancer screening programs in clinical practice. Wiener, RS., Gould, MK., Arenberg, DA., et al.[2022]

Only 10.84% of eligible individuals reported participating in low-dose computed tomography (LDCT) lung cancer screening, indicating that while utilization rates are higher than previous estimates, they remain suboptimal.

Participation in lung cancer screening varied by sex; males with COPD and females with poorer self-reported health were more likely to participate, suggesting that targeted strategies may be needed to improve screening rates among different demographic groups.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Factors associated with low-dose CT lung cancer screening participation in a high burden state: Results from the 2017-2018 BRFSS. Sedani, AE., Ford, LA., James, SA., et al.[2022]

In a study of 4,176 patients undergoing lung cancer screening with low-dose CT, the cancer detection rate was 3.8%, significantly higher than the 2.4% reported in the National Lung Screening Trial, indicating improved effectiveness in real-world settings.

Most cancers detected were early-stage (71% stage I), and the study reported low complication rates (24%) and a lower mortality rate (0.45%) over a median follow-up of 3.3 years, suggesting that lung cancer screening is both safe and effective.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Characteristics and Outcomes of Lung Cancers Detected on Low-Dose Lung Cancer Screening CT. Zhang, EW., Shepard, JO., Kuo, A., et al.[2022]

In a study of 121 patients who underwent low-dose computed tomography (LDCT) screening for lung cancer, the overall adherence rate to follow-up scans was only 59.1%, indicating a need for improved compliance with screening guidelines.

Patients with more concerning findings (Lung-RADS score 2) were 2.43 times more likely to adhere to follow-up scans compared to those with less concerning findings (Lung-RADS score 1), while African American patients showed lower odds of adherence, highlighting potential socioeconomic disparities in lung cancer screening compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient Adherence in an Academic Medical Center's Low-dose Computed Tomography Screening Program. Mortman, KD., Devlin, J., Giang, B., et al.[2023]

A study involving 190 patients revealed that while most felt they understood their lung cancer screening results, only 55% actually understood what a lung nodule is, highlighting significant gaps in patient knowledge.

The development of a commonly asked questions (CAQ) information sheet, refined with input from both patients and clinicians, was found to be helpful in improving understanding of lung nodules and incidental findings, suggesting it could enhance communication between patients and healthcare providers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient and Clinician Recommendations to Improve Communication and Understanding of Lung Cancer Screening Results. Crothers, K., Shahrir, S., Kross, EK., et al.[2023]

A video-based decision aid for lung cancer screening significantly increased patients' knowledge about screening, with correct answers rising from 25.5% to 74.8% after viewing the aid, indicating its effectiveness in educating smokers.

The majority of patients (78.8%) expressed greater interest in lung cancer screening after watching the video, highlighting its potential to enhance informed decision-making among heavy smokers aged 45 to 75.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Feasibility of a patient decision aid about lung cancer screening with low-dose computed tomography. Volk, RJ., Linder, SK., Leal, VB., et al.[2021]

A proactive patient education and recruitment program significantly increased the number of eligible patients for low-dose computed tomography (LDCT) lung cancer screening by 37.3%, from 150 to 206 patients.

In the prospective phase, 59.2% of eligible patients verbally agreed to screening after being contacted by a nurse navigator, highlighting the effectiveness of direct outreach in promoting LDCT screening among at-risk individuals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Proactive Recruitment Strategy for Patient Identification for Lung Cancer Screening. Thuppal, S., Hendren, JR., Colle, J., et al.[2023]

In a study of 11,520 individuals aged 55 to 80 who underwent lung cancer screening with low-dose CT (LDCT), the rates of follow-up imaging and procedures were found to be low, with 17.7% requiring imaging and only 3.1% undergoing procedures within 12 months.

The adjusted rates of specific follow-up procedures were also low, with bronchoscopy at 2.0% and percutaneous biopsy at 1.3%, indicating that while LDCT screening is beneficial, it does not lead to excessive follow-up interventions in a community setting.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Imaging and Diagnostic Procedures After Low-Dose CT Screening for Lung Cancer. Nishi, SPE., Zhou, J., Okereke, I., et al.[2023]

Lung cancer screening using low-dose CT (LDCT) has proven effective in clinical trials, including the National Lung Screening Trial, highlighting its importance in early detection.

The Lung CT Screening Reporting and Data System (Lung-RADS) is recommended for all LDCT exams to improve communication of results and reduce false-positive rates, ensuring better patient care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Screening for Lung Cancer: Lexicon for Communicating With Health Care Providers. Carter, BW., Lichtenberger, JP., Wu, CC., et al.[2018]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9311401/

Low‐dose computed tomography lung cancer screening This trial reported an overall 20% (95% confidence interval [CI], 6.8–26.7; p = 0.004) reduction in lung cancer mortality after 6.5‐years follow‐up when using ...

2. jamanetwork.com jamanetwork.com/journals/jama/fullarticle/2777242

Screening for Lung Cancer With Low-Dose Computed ... The NLST found a reduction in all-cause mortality with LDCT screening compared with chest radiography (1912 vs 2039 deaths; 1141 per 100 000 ...

3. thelancet.com thelancet.com/journals/lanonc/article/PIIS1470-2045(25)00082-8/fulltext

Low-dose CT for lung cancer screening in a high-risk ... At 12 months, the episode sensitivity of our low-dose CT screening protocol for detecting lung cancer was 97·0% (95% CI 95·0–99·1; 261 of 269 ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925003521

Review Current evidence of low-dose CT screening benefit LDCT screening has emerged as a powerful tool for early detection, enabling diagnosis at curable stages and reducing lung cancer mortality.

5. cms.gov cms.gov/medicare-coverage-database/details/nca-decision-memo.aspx?NCAId=274&bc=AAAAAAAAAgAAAA

Screening for Lung Cancer with Low Dose Computed ... The USPSTF noted that “screening with LDCT, CXR, or sputum cytology can detect lung cancer at an earlier stage than lung cancer would be detected in an ...

6. cdc.gov cdc.gov/lung-cancer/screening/index.html

Screening for Lung Cancer The only recommended screening test for lung cancer is low-dose computed tomography (also called a low-dose CT scan, or LDCT).

7. cms.gov cms.gov/medicare-coverage-database/view/ncd.aspx?ncdid=364&ncdver=1

NCD - Lung Cancer Screening with Low Dose Computed ... Low dose computed tomography (LDCT) is a chest CT scan performed at settings to minimize radiation exposure compared to a standard chest CT. Screening for ...

8. uspreventiveservicestaskforce.org uspreventiveservicestaskforce.org/uspstf/recommendation/lung-cancer-screening

Recommendation: Lung Cancer: Screening The USPSTF recommends annual screening for lung cancer with LDCT in adults aged 50 to 80 years who have at least a 20 pack-year smoking history.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4662564/

Assessing the benefits and harms of low-dose computed ... In 2011, the National Lung Screening Trial (NLST) reported that LDCT screening significantly reduced mortality from lung cancer in a high risk population. This ...