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

Sponsor
University of Massachusetts, Worcester (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05021133
Collaborator
Wake Forest University Health Sciences (Other), National Institutes of Health (NIH) (NIH), National Cancer Institute (NCI) (NIH), Meyers Primary Care Institute (Other)
20
Enrollment
1
Arm
13
Anticipated Duration (Months)

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Tele-Navi LCS
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Screening
Official Title:
Tele-Navigation of Lung Cancer Screening
Anticipated Study Start Date :
Jan 1, 2023
Anticipated Primary Completion Date :
Aug 1, 2023
Anticipated Study Completion Date :
Feb 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: Tele-Navi LCS

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.

Behavioral: Tele-Navi LCS
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.

Outcome Measures

Primary Outcome Measures

  1. Completion of Tele-Navi LCS [30 days]

    Number of participants completed Tele-Navi LCS,

Secondary Outcome Measures

  1. Completion of Follow-up LCS [180 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
55 Years to 81 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • University of Massachusetts, Worcester
  • Wake Forest University Health Sciences
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
  • Meyers Primary Care Institute

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Mayuko Ito Fukunaga, Assistant Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier:
NCT05021133
Other Study ID Numbers:
  • H00022916
  • P50CA244693
First Posted:
Aug 25, 2021
Last Update Posted:
Aug 17, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
Yes
Plan to Share IPD:
Yes
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Mayuko Ito Fukunaga, Assistant Professor of Medicine, University of Massachusetts, Worcester
lung cancer
cancer screening
health informatics
Additional relevant MeSH terms:
Lung Neoplasms

Study Results

No Results Posted as of Aug 17, 2022