Tele-Navigation for Lung Cancer Screening

Overseen By Joann L Wagner, MSW

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Massachusetts, Worcester

Disqualifiers: Lung cancer, Active cancer, Pregnancy, others

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

Compensation: Varies

Number of Visits: Unknown

22 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new telehealth program called Tele-Navi LCS, designed to help people adhere to their follow-up lung cancer screenings. The goal is to ensure patients complete their annual check-ups, which can detect issues early and save lives. Individuals who have had a lung cancer screening at UMMH, are overdue for their next one, have the technology for video calls, and speak English might be suitable candidates. As an unphased trial, this study offers a unique opportunity to contribute to innovative healthcare solutions that could enhance patient outcomes.

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

Research shows that Tele-Navi LCS, which uses telehealth coaching for lung cancer screening, is easy for patients to handle. Studies have found that phone-based guidance increases the likelihood of patients completing their screening without major side effects, indicating the program's safety. Additionally, similar telehealth programs have succeeded in other healthcare areas, further proving their safety for clinical trials. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the Tele-Navi LCS trial because it's exploring a novel approach to lung cancer screening using telehealth. Unlike traditional methods that rely heavily on in-person consultations and screenings, Tele-Navi LCS offers personalized telehealth coaching from a Tele-Navigator. This could make lung cancer screening more accessible, especially for patients in remote areas, and potentially increase early detection rates. By integrating telehealth, the trial aims to simplify the screening process and provide continuous support, which could lead to better patient outcomes.

What evidence suggests that Tele-Navi LCS is effective for promoting adherence to lung cancer screening?

Studies have shown that telehealth can help people maintain their medical appointments. For lung cancer screening, researchers developed a system called tele-navigation with input from both patients and healthcare providers. This system ensures patients complete their follow-up screenings. Research shows that this type of patient guidance increases the number of people who get screened and follow up on abnormal results. It also ensures all patients receive the same level of care. In this trial, participants will receive telehealth coaching from a Tele-Navigator through the Tele-Navi LCS system, which aims to help more people adhere to their lung cancer screening schedules, crucial for early detection of lung cancer. ^{1 3 5 6 7}

Who Is on the Research Team?

Mayuko Ito Fukunaga, MD

Principal Investigator

University of Massachusetts, Worcester

Are You a Good Fit for This Trial?

This trial is for English-speaking individuals who are eligible for and overdue a low-dose CT scan (LDCT) as part of lung cancer screening follow-up. Participants must have had their initial screening at UMMH and possess the technology to complete study activities, such as video calls. Those with a previous or active cancer diagnosis, nursing home residents, or pregnant individuals cannot join.

Inclusion Criteria

You are eligible for low-dose computed tomography (LDCT) for lung cancer screening follow-up.

I have had a lung cancer screening at UMMH.

Has technology to complete study activities (e.g., video call visit)

Exclusion Criteria

I have been diagnosed with lung cancer before.

I currently have an active cancer diagnosis.

Is a nursing home or group care resident

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Tele-Navi LCS Intervention

Participants receive telehealth coaching from a Tele-Navigator for lung cancer screening

30 days

Telehealth sessions

Follow-up

Participants are monitored for adherence to follow-up lung cancer screening using low-dose CT

180 days

What Are the Treatments Tested in This Trial?

Interventions

• Tele-Navi LCS

Trial Overview The Tele-Navi LCS intervention uses telehealth to improve adherence to follow-up lung cancer screenings. The study will create this program with patient input and test its feasibility in primary care by tracking if participants complete it and their subsequent LDCT within 180 days.

How Is the Trial Designed?

Group I: Tele-Navi LCS Experimental Treatment 1 Intervention

Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS

Who Is Running the Clinical Trial?

University of Massachusetts, Worcester

Lead Sponsor

Trials

372

Recruited

998,000+

Meyers Primary Care Institute

Collaborator

Trials

1

Recruited

20+

Wake Forest University Health Sciences

Collaborator

Trials

1,432

Recruited

2,506,000+

National Institutes of Health (NIH)

Collaborator

Trials

2,896

Recruited

8,053,000+

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38746205/

a study protocol for delivering shared decision-making for lung ... This protocol describes a telehealth decision coaching intervention for LCS in primary care clinics delivered by patient navigators.

2. bmcprimcare.biomedcentral.com bmcprimcare.biomedcentral.com/articles/10.1186/s12875-024-02610-2

a study protocol for delivering shared decision-making for lung ... This protocol describes a telehealth decision coaching and navigation intervention for LCS in primary care clinics delivered by patient navigators.

3. app.trialscreen.org app.trialscreen.org/trials/lung-cancer-tele-navigation-screening-navi-lcs-trial-nct05021133

Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS) Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS) is an intervention co-created with patients and LCS stakeholders using telehealth.

4. withpower.com withpower.com/trial/phase-lung-neoplasms-8-2021-99ae4

Tele-Navigation for Lung Cancer Screening Trial Overview The Tele-Navi LCS intervention uses telehealth to improve adherence to follow-up lung cancer screenings. The study will create this program with ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12131312/

Effect of Patient Navigation on Completion of Lung Cancer ... Specifically, navigation may improve rates of screening and follow-up for abnormal results; it can also decrease disparities in care, particularly for breast ...

6. 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.

7. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2836556

Homelessness, Patient Navigation, and Lung Cancer ... Patient navigation significantly improved lung cancer screening completion among both those currently (20% absolute increase) and formerly (41% absolute ...