Patient Navigation for Lung Cancer Screening

(HEALS Trial)

Recruiting at 2 trial locations

Overseen By Massey IIT Research Operations

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Virginia Commonwealth University

Disqualifiers: Cancer history, Hemoptysis, Non-English, others

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

Compensation: Varies

Number of Visits: Unknown

225 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a patient navigator service, which provides guidance and support, increases the number of individuals completing lung cancer screening. This screening involves a low-dose CT scan to detect lung cancer. Navigators assist with understanding the process, handling logistics, and managing costs. The trial seeks Black or African-American individuals who have smoked the equivalent of a pack a day for 20 years, currently smoke or quit within the last 15 years, and are willing to participate in all study components. Individuals with a history of cancer or who have already undergone lung screening are not eligible. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance lung cancer screening access and support within the community.

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

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that patient navigation is safe for lung cancer screening?

Research shows that patient navigation is generally safe for individuals undergoing lung cancer screening. Since it is not a drug or medical procedure, it presents no specific safety concerns. Instead, trained professionals guide patients through the healthcare system, assisting with scheduling appointments, understanding medical information, and overcoming obstacles to care.

Studies have shown that patient navigation can be particularly helpful for those who might struggle to access healthcare. For instance, research found it effective in promoting lung cancer screening among people experiencing homelessness, indicating its positive reception and benefits across various groups.

Overall, the focus remains on making healthcare easier to understand and access. As a supportive service rather than a physical treatment, it has no reported negative side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about patient navigation for lung cancer screening because it offers a personalized approach to overcoming barriers that prevent people from getting screened. Unlike traditional methods, which can be impersonal and confusing for patients, this approach involves trained navigators who assist patients with clinical, logistical, and financial challenges, tailored specifically to their needs. This personalized guidance helps ensure that more people get screened and treated promptly, potentially leading to earlier detection and better outcomes for lung cancer patients.

What evidence suggests that patient navigation is effective for lung cancer screening?

Research has shown that patient navigators can increase lung cancer screening rates. In this trial, participants will receive patient navigation services to assist with the clinical, logistical, and financial aspects of lung cancer screening. Studies have found that navigators help patients, especially those in vulnerable groups, overcome obstacles to screening. For example, one study found that navigation effectively encouraged screening among people experiencing homelessness. Another study highlighted how navigators assist patients by addressing medical, practical, and financial challenges. Overall, patient navigation has increased participation and completion of lung cancer screenings. ^{1 2 4 6 7}

Who Is on the Research Team?

Vanessa Sheppard, PhD

Principal Investigator

Virginia Commonwealth University

Are You a Good Fit for This Trial?

This trial is for Black or African-American individuals who currently smoke or quit within the last 15 years, have a significant smoking history (20 pack-years), and meet USPSTF guidelines for lung cancer screening. They must be willing to participate in all study activities and sign consent forms. People with certain cancers, COPD, emphysema, recent coughing up blood, or conditions affecting study compliance can't join.

Inclusion Criteria

I am a current smoker or quit smoking within the last 15 years.

I am willing to participate in all required study activities.

Meets current USPSTF guidelines for lung cancer screening (LCS)

Exclusion Criteria

I cannot speak English.

I have not had cancer (except skin cancer), COPD, emphysema, or coughed up blood in the last 5 years.

Medical, psychological, or social condition that, in the opinion of the investigator, may increase the patient's risk or limit the patient's adherence with study requirements

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Patient Navigation Intervention

Centralized patient navigators help patients navigate the clinical, logistical, and financial aspects of lung cancer screening (LCS).

2 weeks to 4 months

Varies by participant

Follow-up

Participants are monitored for health-related quality of life and satisfaction with the navigation program.

2 weeks to 4 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview The trial is testing a patient navigation program's effectiveness in increasing the number of participants completing lung cancer screenings via low dose computed tomography (LDCT). It focuses on whether this educational support helps people follow through with recommended screenings.

How Is the Trial Designed?

Group I: Patient Navigation Experimental Treatment 1 Intervention

Centralized patient navigators will be trained to help patients navigate the clinical, logistical, and financial aspects of LCS. Navigators employ case management approaches based on social work principles. The experience of patient navigation will be tailored to the individual participant

Who Is Running the Clinical Trial?

Virginia Commonwealth University

Lead Sponsor

Trials

732

Recruited

22,900,000+

Stand Up To Cancer

Collaborator

Trials

53

Recruited

40,100+

Published Research Related to This Trial

Implementing a patient navigation (PN) program for Medicare beneficiaries with lung cancer is cost-effective, yielding better health outcomes despite higher costs, with an incremental cost-effectiveness ratio of $19,312 per quality-adjusted life year (QALY).

The analysis showed a high probability (80-91%) that the PN program is cost-effective at societal willingness-to-pay thresholds of $50,000 and $100,000 per QALY, indicating strong support for this intervention in improving care coordination and treatment timeliness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cost-Effectiveness Analysis of a Capitated Patient Navigation Program for Medicare Beneficiaries with Lung Cancer. Shih, YC., Chien, CR., Moguel, R., et al.[2022]

A study involving 1345 patients with abnormal cancer screenings or cancer diagnoses found a significant correlation between satisfaction with patient navigators and overall satisfaction with cancer-related care, indicating that effective navigation can enhance patient experiences.

Factors such as having an abnormal colorectal cancer screening and being older or from a minority racial-ethnic background were linked to higher satisfaction levels, suggesting that tailored navigation support may help address disparities in cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. Jean-Pierre, P., Cheng, Y., Wells, KJ., et al.[2022]

A patient navigation program significantly increased lung cancer screening rates among high-risk smokers, with 31% of those in the intervention group receiving chest CTs compared to only 17.3% in the control group.

The program also led to a higher percentage of eligible participants undergoing lung cancer screening (92% in the intervention group), resulting in a diagnosis of lung cancer in 2% of screened patients, highlighting its efficacy in early detection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. Percac-Lima, S., Ashburner, JM., Rigotti, NA., et al.[2019]

In a randomized controlled trial involving 319 patients with breast and colorectal cancer, patient navigation did not show a statistically significant effect on cancer-specific quality of life (QOL) compared to usual care.

While the emotional well-being of the patient navigation group showed a change that approached significance, overall QOL measures did not differ significantly, suggesting that patient navigation may not enhance QOL during cancer treatment in this study's context.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. Hendren, S., Griggs, JJ., Epstein, R., et al.[2021]

Patient navigation (PN) significantly reduced the time from definitive diagnosis to initiation of therapy for breast cancer, with an average of 57 days for the PN group compared to 74 days for the control group, indicating improved efficiency in cancer care.

Hispanic women who received PN were more likely to be diagnosed and start treatment within 60 days of abnormal screening tests, highlighting PN's potential to address health disparities in minority populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. Dudley, DJ., Drake, J., Quinlan, J., et al.[2021]

Nurse navigation in oncology care has been shown to significantly improve patient outcomes for those with advanced non-small-cell lung cancer by increasing the proportion of patients receiving timely systemic treatment and enhancing access to molecular testing.

At the BC Cancer Agency, nurse navigators helped shorten the time to treatment and ensured that more patients had their molecular test results available during their initial consultation, demonstrating the effectiveness of this approach in managing complex cancer care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integration of a nurse navigator into the triage process for patients with non-small-cell lung cancer: creating systematic improvements in patient care. Zibrik, K., Laskin, J., Ho, C.[2018]

In a study involving 222 patients, those who received patient navigation (PN) for cancer screening reported significantly higher satisfaction with their overall medical care compared to those who did not receive PN (71.0 vs 66.8).

The results suggest that PN programs can enhance patient satisfaction, particularly for individuals at high risk of not adhering to recommended cancer screening, indicating a potential benefit for improving care quality and equity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. Hermann, EA., Ashburner, JM., Atlas, SJ., et al.[2022]

Patient navigation can significantly improve access to care and support for vulnerable cancer patients, particularly those with low income, low education, and multiple health issues, as shown by recent analyses of the Patient Navigation Research Program.

To be most effective, patient navigation programs should be tailored to address the specific challenges faced by these high-risk populations, requiring careful planning and integration into existing healthcare systems.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Implementation of evidence-based patient navigation programs. Freund, KM.[2017]

The National Patient Navigation Leadership Summit, held by the American Cancer Society in March 2010, aimed to create a consensus on key outcomes to measure the effectiveness of patient navigation in cancer care.

The Summit brought together a diverse group of experts to propose core metrics that can evaluate the impact of patient navigation on both individual patients and broader populations, providing a framework for future navigation programs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Measuring the impact and potential of patient navigation: proposed common metrics and beyond. Esparza, A., Calhoun, E.[2021]

Patient navigation can help reduce cancer disparities in vulnerable populations, which often experience worse outcomes and lower screening rates, but there is limited research specifically on lung cancer navigation.

The authors reviewed 26 studies and proposed standardized metrics for evaluating lung cancer navigation programs, including screening rates, follow-up compliance, time to treatment, patient satisfaction, quality of life, biopsy complications, and cultural competency.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Case for Patient Navigation in Lung Cancer Screening in Vulnerable Populations: A Systematic Review. Shusted, CS., Barta, JA., Lake, M., et al.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6685525/

The Case for Patient Navigation in Lung Cancer Screening in ... Patient navigation has been proposed to combat cancer disparities in vulnerable populations. Vulnerable populations often have poorer cancer outcomes and ...

2. lungcancerpolicynetwork.com lungcancerpolicynetwork.com/new-report-outlines-the-crucial-role-of-patient-navigators-in-the-delivery-of-lung-cancer-care/

New report outlines the crucial role of patient navigators in ... The Lung Cancer Policy Network has published a new report detailing the importance of establishing high-quality patient navigation for lung cancer.

3. jamanetwork.com jamanetwork.com/journals/jamainternalmedicine/fullarticle/2819819

Patient Navigation for Lung Cancer Screening at a Health ... Study findings suggest that patient navigation may be an effective tool for promoting lung cancer screening engagement among people experiencing homelessness.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0959804925005131

A randomized trial of patient navigation with symptom ... Patient navigators can help overcome barriers to cancer care. We evaluated the impact of patient navigation with symptom-monitoring in patients ...

5. acsjournals.onlinelibrary.wiley.com acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21788

Patient navigation across the cancer care continuum: An ... Two reviews included outcomes relating to cancer screening knowledge and reported that patient navigation interventions, particularly with nurse ...

6. lungcancerpolicynetwork.com lungcancerpolicynetwork.com/app/uploads/Patient-navigation-for-lung-cancer-an-essential-component-of-care.pdf

Patient navigation for lung cancer: an essential component ... 1 Earlier detection leads to the best outcomes; but even when lung cancer is diagnosed early, the next steps of care can be complicated due to access issues, ...

7. ascopubs.org ascopubs.org/doi/10.1200/JCO.2023.41.16_suppl.10577

Patient navigation for lung cancer screening in an urban ... We conducted a pragmatic randomized controlled trial of telephone-based navigation for LCS within an integrated, urban safety-net healthcare system.