Patient Navigation for Lung Cancer

Not yet recruiting at 1 trial location

Overseen By Matty Triplette, MD, MPH

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Fred Hutchinson Cancer Center

Disqualifiers: Recent chest CT, Lung cancer history

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 tailored patient navigation can boost lung cancer screening rates in tribal communities in western Washington state. Lung cancer poses a significant concern among American Indian and Alaska Native people, and this trial focuses on assisting those who face barriers to screening. Participants will receive support to better navigate the healthcare system, facilitating screening and follow-up care. Individuals who have smoked for 20 years or more, currently use tobacco, and have recently visited a doctor at a participating clinic may find this trial suitable. As an unphased trial, this study offers a unique opportunity to contribute to research that could enhance healthcare access and outcomes in the community.

Do I have to stop taking my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It focuses on lung cancer screening and patient navigation, so it's best to discuss your medications with the trial coordinators or your doctor.

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

Research has shown that patient navigation (PN) is generally safe and well-received. Studies of similar programs have not identified any major safety concerns. For example, in projects assisting with lung cancer screening, patient navigation has facilitated participation without causing harm. These programs guide individuals through healthcare steps and do not involve new drugs or invasive procedures, which often carry higher risks. This suggests that the PN program should be quite safe for participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about this trial because it explores how tailored patient navigation (PN) can improve lung cancer screening (LCS) uptake and follow-up. Unlike standard care, which often relies solely on educational materials and brief discussions with healthcare providers, this approach offers personalized support over an extended period, aiming to guide patients through the often-complicated process of cancer screening. This tailored support could potentially lead to earlier detection and better outcomes for lung cancer patients by ensuring they complete necessary screenings and follow-up care. By comparing tailored PN to enhanced usual care, researchers hope to identify how personalized interventions might significantly improve patient engagement and health outcomes.

What evidence suggests that tailored patient navigation is effective for improving lung cancer screening in tribal communities?

Studies have shown that personalized help, known as patient navigation, can increase lung cancer screening rates among high-risk groups. In this trial, participants in Arm 1 will receive tailored patient navigation (PN) activities to support the uptake and follow-up of lung cancer screening (LCS) for 21 months. Research indicates that this approach assists people who face challenges accessing healthcare, such as those in tribal communities, to participate more in lung cancer screening. Previous findings from various settings, including among LGBTQ+ individuals and people experiencing homelessness, suggest that patient navigation supports both screening and quitting smoking. Tailored navigation services help people understand and move through the healthcare system, making it easier to get screened and follow up on results. This method shows promise for increasing lung cancer screening in communities with higher smoking rates and lower screening participation. ^{1 2 3 6 7}

Who Is on the Research Team?

Matty Triplette, MD, MPH

Principal Investigator

Fred Hutch/University of Washington Cancer Consortium

Are You a Good Fit for This Trial?

This trial is for American Indian and Alaska Native people aged 50-80 in western Washington who smoke or have smoked heavily. It aims to help them get lung cancer screenings by using a special support program called patient navigation, which is customized for their tribal communities.

Inclusion Criteria

AIM 1 RANDOMIZED CONTROLLED TRIAL: Self-reported 20-pack year smoking history

AIM 1 RANDOMIZED CONTROLLED TRIAL: Ongoing commercial tobacco use within the past 15 years

AIM 1 RANDOMIZED CONTROLLED TRIAL: Seen by a PCP at a participating clinic (South Puget Intertribal Planning Agency [SPIPA] or Muckleshoot) within the past three years

Exclusion Criteria

AIM 1 RANDOMIZED CONTROLLED TRIAL: Has had a documented chest CT within the past one year

I have had lung cancer or symptoms related to it.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Enhanced Usual Care

Participants receive an educational handout on LCS and a warm hand-off to discuss LCS with their PCP

6 months

Tailored Patient Navigation

Participants receive tailored PN activities in support of the uptake and follow-up of LCS

21 months

Follow-up

Participants are monitored for completion of chest CT and adherence to follow-up steps

Up to 15 months

What Are the Treatments Tested in This Trial?

Interventions

• Tailored Patient Navigation

Trial Overview The study tests if tailored patient navigation can increase lung cancer screening rates among tribal community members. It involves surveys, health record reviews, educational materials, interviews, and following best practices to guide participants through the healthcare system.

How Is the Trial Designed?

Group I: Arm 1 (tailored PN) Experimental Treatment 5 Interventions

Participants receive tailored PN activities in support of the uptake and follow-up of LCS for 21 months. Participants also receive an educational handout on LCS on study.

Group II: Arm 2 (enhanced usual care, delayed tailored PN) Active Control 5 Interventions

Participants receive enhanced usual care consisting of an educational handout on LCS and a warm hand-off to discuss LCS with their PCP for 6 months. Participants then receive tailored PN services in support of the uptake and follow-up of LCS for 15 months.

Who Is Running the Clinical Trial?

Fred Hutchinson Cancer Center

Lead Sponsor

Trials

583

Recruited

1,341,000+

National Institute on Minority Health and Health Disparities (NIMHD)

Collaborator

Trials

473

Recruited

1,374,000+

Citations

1. atsjournals.org atsjournals.org/doi/10.1513/AnnalsATS.202502-215OC

Tailored Patient Navigation to Support Lung Cancer ... Through prior community-engaged work, we developed a patient navigation intervention to support smoking cessation and lung cancer screening (LCS) ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40440319/

Tailored Patient Navigation to Support Lung Cancer ... Tailored patient navigation is a promising approach to enhance LCS uptake and smoking cessation in LCS-eligible LGBTQ+ individuals.

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/S2347562525000940

Interventions targeted to improve lung cancer screening ... Combined intervention and patient navigation are most effective in increasing lung cancer screening uptake among high-risk individuals.

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. ascopubs.org ascopubs.org/doi/10.1200/JCO.2022.40.28_suppl.121

Lessons learned from a lung cancer screening patient ... Results: Of the LDCT-eligible patients, PNs were able to complete two or more navigation calls with 55.62% of patients assigned. 77% of patients ...

7. 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 ... In settings where navigators have been introduced, screening processes for lung cancer are more streamlined,41‑43 echoing similar results seen with other cancer ...