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

Trial Summary

What is the purpose of this trial?

Evaluate the impact of the patient navigation program on the proportion of patients who complete lung cancer screening (LCS), defined as undergoing a low dose computed tomography (LDCT)

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 data supports the effectiveness of the treatment Patient Navigation for Lung Cancer Screening?

Research shows that patient navigation programs can improve cancer screening rates and quality of life for cancer patients, especially in underserved populations. These programs help ensure patients receive timely care and support, which can lead to better health outcomes. ^{1 2 3 4 5}

Is patient navigation safe for humans?

Patient navigation has been used safely in various healthcare settings to help people access cancer care and screenings. It has been shown to improve access to timely care without any reported safety concerns. ^{3 4 6 7 8}

How does patient navigation differ from other treatments for lung cancer?

Patient navigation is unique because it focuses on guiding patients through the healthcare system, ensuring timely access to screenings, treatments, and support, especially for vulnerable populations. Unlike traditional treatments that directly target the cancer, patient navigation helps improve overall care coordination and patient satisfaction by addressing barriers to care. ^{3 7 8 9 10}

Research Team

Vanessa Sheppard, PhD

Principal Investigator

Virginia Commonwealth University

Eligibility Criteria

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.

Meets current USPSTF guidelines for lung cancer screening (LCS)

I am willing to participate in all required study activities.

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

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

Satisfaction With Health Care Among Patients Navigated for Preventive Cancer Screening. [2022]

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

Randomized controlled trial of patient navigation for newly diagnosed cancer patients: effects on quality of life. [2021]

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

Cost-Effectiveness Analysis of a Capitated Patient Navigation Program for Medicare Beneficiaries with Lung Cancer. [2022]

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

Beneficial effects of a combined navigator/promotora approach for Hispanic women diagnosed with breast abnormalities. [2021]

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

Measuring the impact and potential of patient navigation: proposed common metrics and beyond. [2021]

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

Patient navigation for lung cancer screening among current smokers in community health centers a randomized controlled trial. [2019]

7. Switzerland 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. [2018]

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

The Case for Patient Navigation in Lung Cancer Screening in Vulnerable Populations: A Systematic Review. [2020]

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

Satisfaction with cancer care among underserved racial-ethnic minorities and lower-income patients receiving patient navigation. [2022]

10. England pubmed.ncbi.nlm.nih.gov

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