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

6772 Participants Needed

Trial Summary

What is the purpose of this trial?

This clinical trial tests the impact of lung cancer screening care coordination interventions implemented at the system-level on lung cancer screening adherence in community settings. Lung cancer remains the leading cause of cancer death in the United States. Although lung cancer screening (LCS) with yearly low-dose chest computed tomography has the potential to decrease lung deaths, the use of this screening technique remains low. In addition, studies have shown that adherence to lung cancer screening in clinical settings is far lower that those found in clinical trials. Improved care coordination services that include comprehensive, system-wide tracking of screening outcomes for all LCS participants, results reporting with direct-to-patient information, direct patient and physician communication, and active reviews of non-adherent patients and stepped support interventions may increase patient adherence to LCS. Coordination services at the system-level may decrease barriers and improve adherence to lung cancer screening in community settings.

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 data supports the effectiveness of the treatment Patient Navigation, Patient Navigation Services, Care Coordination, Healthcare Navigation for lung cancer screening?

Research shows that patient navigation programs can improve cancer outcomes by helping patients get timely and complete cancer diagnostics, which can lead to better survival rates, as seen in non-small cell lung cancer patients. ^{1 2 3 4 5}

Is patient navigation safe for humans?

Patient navigation, also known as care coordination or healthcare navigation, has been used safely in various healthcare settings to help patients manage their care, including lung cancer screening. There is no specific safety data indicating harm from these programs, suggesting they are generally safe for human use. ^{1 5 6 7 8}

How is the Patient Navigation treatment for lung cancer screening different from other treatments?

Patient Navigation is unique because it focuses on guiding patients through the healthcare system, helping them understand their screening options, and overcoming barriers to accessing care, rather than directly treating the cancer itself. This approach is particularly beneficial for underserved populations, improving screening rates and ensuring continuity of care. ^{1 7 9 10 11}

Research Team

Matthew Triplette

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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 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]

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]

References

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

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

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

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

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

Patient navigation to improve follow-up of abnormal mammograms among disadvantaged women. [2018]

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

Impact of Patient Navigation on Population-Based Breast Screening: a Systematic Review and Meta-analysis of Randomized Clinical Trials. [2023]

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

Improved survival of non-small cell lung cancer patients after introducing patient navigation: A retrospective cohort study with propensity score weighted historic control. [2022]

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

Impact of patient navigation on timely cancer care: the Patient Navigation Research Program. [2022]

7. 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]

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

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

9. Switzerland pubmed.ncbi.nlm.nih.gov

Implementing Lung Cancer Screening and Prevention in Academic Centers, Affiliated Network Offices and Collaborating Care Sites. [2021]

10. Canada pubmed.ncbi.nlm.nih.gov

The role of oncology nurse navigators in facilitating continuity of care within the diagnostic phase for adult patients with lung cancer. [2022]

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

Comparing clinical and nonclinical cancer patient navigators: A national study in the United States. [2023]