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

NCT05021133 | Completed Results

• 2 other identifiers: H00022916P50CA244693
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lung Cancer

Keywords

lung cancer; cancer screening; health informatics

Outcome Measures

Primary Outcomes (1)

• Completion of Tele-Navi LCS

  Number of participants completed Tele-Navi LCS,

  30 days

Secondary Outcomes (1)

• Completion of Follow-up LCS

  180 days

Study Arms (1)

Tele-Navi LCS

OTHER

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

Behavioral: Tele-Navi LCS

Interventions

Tele-Navi LCS BEHAVIORAL

Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call

Tele-Navi LCS

Eligibility Criteria

• Age: 50 Years - 77 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Massachusetts, Worcester: lead
• Wake Forest University Health Sciences: collaborator
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

UMass Chan Medical School

Worcester, Massachusetts, 01655, United States

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Results Point of Contact

• Title: Mayuko Ito Fukunaga
• Organization: UMass Chan Medical School

mayuko.itofukunaga@umassmed.edu

5088561975

Study Officials

• Mayuko Ito Fukunaga, MD

  University of Massachusetts, Worcester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Medicine

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 25, 2021
• Study Start: June 5, 2023
• Primary Completion: August 11, 2023
• Study Completion: December 12, 2025
• Last Updated: January 8, 2026
• Results First Posted: August 29, 2024

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL

Locations

US (1)