Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)

December 15, 2025 updated by: Mayuko Ito Fukunaga, University of Massachusetts, Worcester

Tele-Navigation of Lung Cancer Screening

Adherence to annual follow up is critical to achieving mortality benefits and optimizing cost-effectiveness of lung cancer screening (LCS). However, adherence to LCS follow-up in the real world is suboptimal. Using telehealth, the investigators will co-create Tele-Navigation of Lung Cancer Screening with patients and LCS stakeholders as an intervention to promote adherence of follow-up LCS. The investigators will then implement the Tele-Navi LCS intervention to a pilot sample of patients and evaluate its feasibility in the primary care setting. The investigators will measure the number of patient participants who completed Tele-Navi LCS and follow-up LCS within 180 days from Tele-Navi LCS.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

22

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Worcester, Massachusetts, United States, 01655
        • UMass Chan Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

55 years to 81 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Is eligible for LDCT for LCS follow-up
  • Has technology to complete study activities (e.g., video call visit)
  • English speaker
  • Has undergone LCS at UMMH
  • Is overdue for LDCT follow-up

Exclusion Criteria:

  • Has previous diagnosis of lung cancer
  • Has active cancer diagnosis
  • Is a nursing home or group care resident
  • Is pregnant

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Screening
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Tele-Navi LCS
Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS
Behavioral: Tele-Navi LCS
Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of Tele-Navi LCS
Time Frame: 30 days
Number of participants completed Tele-Navi LCS,
30 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Completion of Follow-up LCS
Time Frame: 180 days
Number of participants who received a low-dose CT (LDCT) for LCS follow-up
180 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Massachusetts, Worcester

Collaborators

National Cancer Institute (NCI)
National Institutes of Health (NIH)
Wake Forest University Health Sciences

Investigators

  • Principal Investigator: Mayuko Ito Fukunaga, MD, University of Massachusetts, Worcester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 5, 2023

Primary Completion (Actual)

August 11, 2023

Study Completion (Actual)

December 12, 2025

Study Registration Dates

First Submitted

August 10, 2021

First Submitted That Met QC Criteria

August 19, 2021

First Posted (Actual)

August 25, 2021

Study Record Updates

Last Update Posted (Estimated)

January 8, 2026

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H00022916
  • P50CA244693 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

A de-identified (by HIPAA standards) dataset may be made available to the public with PI approval.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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