Centralized Interventions for Lung Cancer Screening

Overseen By Tinnie Louie

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Age, Smoking history, Screening location, others

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

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if better care coordination, known as Patient Navigation, can increase adherence to lung cancer screenings. Lung cancer is a leading cause of cancer deaths, and regular screenings with low-dose chest CTs can detect it early. The trial tests whether a dedicated care coordinator can facilitate patient follow-through with these screenings. Suitable participants have smoked for over 20 years, are current or recent smokers, and have undergone at least one lung cancer screening. As an unphased trial, this study provides a unique opportunity to contribute to research that could enhance lung cancer screening processes for many.

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 is best to consult with the trial coordinators or your doctor for guidance.

What prior data suggests that this care coordination intervention is safe for lung cancer screening?

Research shows that patient navigation, the focus of this trial, is generally manageable for participants. Past studies have found patient navigation promising in helping individuals maintain lung cancer screening. For instance, a study involving people experiencing homelessness found that patient navigation increased their participation in lung cancer screening. This indicates that the approach is safe and effective in various situations.

Patient navigation involves guiding patients through the healthcare system, reducing confusion and improving access to care. As a non-invasive approach, it typically presents fewer safety concerns compared to direct medical procedures. Overall, evidence suggests that patient navigation is a safe method to support adherence to lung cancer screening. ^{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 touch that current options lack. Unlike traditional methods that often leave patients to navigate complex healthcare systems on their own, this approach provides dedicated care coordinators to guide patients through screening follow-ups, ensuring they receive timely and coordinated care. This hands-on support can potentially improve screening adherence and early detection rates, which is crucial in managing lung cancer effectively.

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

Research has shown that patient navigators can greatly improve lung cancer screening rates. In this trial, participants will receive lung cancer screening follow-up care coordination services, provided by a lung cancer screening care coordinator at their care site. Patient navigators guide and support patients through the screening process, playing a key role in increasing participation in screenings and follow-up appointments. This support is especially beneficial for vulnerable groups, such as those without stable housing, where patient navigators have proven to boost engagement with lung cancer screening. By offering direct support and communication, patient navigators help remove obstacles, making it easier for patients to complete necessary screenings. Overall, patient navigation has positively impacted adherence to lung cancer screening schedules. ^{1 2 4 6 7}

Who Is on the Research Team?

Matthew Triplette

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for individuals who are eligible for lung cancer screening. It aims to improve how often people get screened by using system-level interventions like electronic health record reviews, interviews, and patient navigation in community settings.

Inclusion Criteria

Current or former (within 15 years) smoker

I am between 50 and 80 years old.

Affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center for PROVIDER INTERVIEWS

Exclusion Criteria

Documented move out of healthcare system for AIM II

I am under 18 years old.

Do not have an affiliation with Skagit Regional Health System, Confluence Health or Kadlec Regional Medical Center for PROVIDER INTERVIEWS

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Intervention

Participants receive lung cancer screening follow-up care coordination services

48 months

Follow-up

Participants are monitored for adherence to lung cancer screening follow-up

48 months

What Are the Treatments Tested in This Trial?

Interventions

• Patient Navigation

Trial Overview The ACCELL Trial is testing whether coordinated care services can increase adherence to yearly low-dose chest CT scans for lung cancer screening. These services include tracking outcomes, providing direct information to patients, communicating with doctors and patients, and supporting those not following the screening schedule.

How Is the Trial Designed?

Group I: Screening (LCS coordination) Experimental Treatment 3 Interventions

Patients receive lung cancer screening follow-up care coordination services, delivered by a lung cancer screening care coordinator at their care site.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Published Research Related to This Trial

A nationwide survey of 527 oncology navigators revealed that clinical navigators (76.1% of participants) are more likely to have higher education (88.6% with a bachelor's degree or higher) and are primarily funded by operational budgets, indicating a more stable employment environment compared to nonclinical navigators.

Clinical navigators provide a wider range of services, including basic navigation, care coordination, and treatment support, and are more engaged in critical areas of cancer care such as treatment, end-of-life, and palliative care navigation, highlighting their essential role in the cancer care continuum.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing clinical and nonclinical cancer patient navigators: A national study in the United States. Wells, KJ., Wightman, P., Cobian Aguilar, R., et al.[2023]

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]

In a study involving 10,521 participants with abnormal cancer screenings and 2,105 with cancer diagnoses, patient navigation significantly improved the timeliness of diagnostic resolution and treatment initiation after 90 days, with adjusted hazard ratios of 1.51 and 1.43, respectively.

The effectiveness of patient navigation was particularly notable in centers where there were greater delays in follow-up care, suggesting that this intervention is especially beneficial for populations at risk of being lost to follow-up.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. Freund, KM., Battaglia, TA., Calhoun, E., et al.[2022]

A patient navigation (PN) program significantly improved follow-up care for disadvantaged women with abnormal mammograms, with 90.4% receiving appropriate follow-up compared to 75.3% in practices without PN.

Women in the PN program also experienced quicker follow-up times, especially for BI-RADS 3 findings, where the likelihood of timely follow-up was more than double compared to non-PN practices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. Percac-Lima, S., Ashburner, JM., McCarthy, AM., et al.[2018]

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]

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]

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]

Patient navigation (PN) significantly improves breast cancer screening completion rates, with an odds ratio of 2.0, indicating that those receiving navigation are twice as likely to complete screening compared to those who do not.

PN also reduces the time to diagnosis by an average of 9.9 days, enhancing the efficiency of the screening process, although it does not affect the resolution of abnormal test results.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Patient Navigation on Population-Based Breast Screening: a Systematic Review and Meta-analysis of Randomized Clinical Trials. Tian, L., Huang, L., Liu, J., et al.[2023]

Citations

1. 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 ...

2. 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 ...

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK535466/

Results - Patient Navigation Models for Lung Cancer - NCBI We identified four SRs– that examined patient navigation across the cancer care continuum, including screening,, diagnosis,, and treatment., The main cancer ...

4. 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.

5. 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.

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.