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

Primary Purpose

Lung Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tele-Navi LCS
Sponsored by
University of Massachusetts, Worcester
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Lung Cancer focused on measuring lung cancer, cancer screening, health informatics

Eligibility Criteria

50 Years - 77 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Has UMMHC PCP
  • Is eligible for LDCT for LCS follow-up
  • Has technology to complete study activities (e.g., video call visit)
  • English speaker
  • Is due for LDCT follow-up in the next 3-6 months

Exclusion Criteria:

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

Sites / Locations

  • UMass Chan Medical School

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Tele-Navi LCS

Arm Description

Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS to access a patient portal and a video-call system.

Outcomes

Primary Outcome Measures

Completion of Tele-Navi LCS
Number of participants completed Tele-Navi LCS,

Secondary Outcome Measures

Completion of Follow-up LCS
Number of participants who received a low-dose CT (LDCT) for LCS follow-up

Full Information

First Posted
August 10, 2021
Last Updated
September 1, 2023
Sponsor
University of Massachusetts, Worcester
Collaborators
Wake Forest University Health Sciences, National Institutes of Health (NIH), National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT05021133
Brief Title
Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)
Official Title
Tele-Navigation of Lung Cancer Screening
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
August 11, 2023 (Actual)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Massachusetts, Worcester
Collaborators
Wake Forest University Health Sciences, National Institutes of Health (NIH), National Cancer Institute (NCI)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer
Keywords
lung cancer, cancer screening, health informatics

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Tele-Navi LCS
Arm Type
Other
Arm Description
Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS to access a patient portal and a video-call system.
Intervention Type
Behavioral
Intervention Name(s)
Tele-Navi LCS
Intervention Description
Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS to access a patient portal and a video-call system.
Primary Outcome Measure Information:
Title
Completion of Tele-Navi LCS
Description
Number of participants completed Tele-Navi LCS,
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Completion of Follow-up LCS
Description
Number of participants who received a low-dose CT (LDCT) for LCS follow-up
Time Frame
180 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
77 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mayuko Ito Fukunaga, MD
Organizational Affiliation
University of Massachusetts, Worcester
Official's Role
Principal Investigator
Facility Information:
Facility Name
UMass Chan Medical School
City
Worcester
State/Province
Massachusetts
ZIP/Postal Code
01655
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
A de-identified (by HIPAA standards) dataset may be made available to the public with PI approval.

Learn more about this trial

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

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