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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05021133
Recruitment Status : Not yet recruiting
First Posted : August 25, 2021
Last Update Posted : August 26, 2022
Sponsor:
Collaborators:
Wake Forest University Health Sciences
National Institutes of Health (NIH)
National Cancer Institute (NCI)
Meyers Primary Care Institute
Information provided by (Responsible Party):
Mayuko Ito Fukunaga, University of Massachusetts, Worcester

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
Lung Cancer Behavioral: Tele-Navi LCS Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : December 1, 2022
Estimated Primary Completion Date : August 1, 2023
Estimated Study Completion Date : February 1, 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lung Cancer

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Completion of Tele-Navi LCS [ Time Frame: 30 days ]
    Number of participants completed Tele-Navi LCS,


Secondary Outcome Measures :
  1. Completion of Follow-up LCS [ Time Frame: 180 days ]
    Number of participants who received a low-dose CT (LDCT) for LCS follow-up



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   55 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05021133


Contacts
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Contact: Joann L Wagner, MSW (508) 791-7392 Joann.Wagner@umassmed.edu

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
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Principal Investigator: Mayuko Ito Fukunaga, MD University of Massachusetts, Worcester
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Responsible Party: Mayuko Ito Fukunaga, Assistant Professor of Medicine, University of Massachusetts, Worcester
ClinicalTrials.gov Identifier: NCT05021133    
Other Study ID Numbers: H00022916
P50CA244693 ( U.S. NIH Grant/Contract )
First Posted: August 25, 2021    Key Record Dates
Last Update Posted: August 26, 2022
Last Verified: August 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: A de-identified (by HIPAA standards) dataset may be made available to the public with PI approval.
Supporting Materials: Study Protocol

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mayuko Ito Fukunaga, University of Massachusetts, Worcester:
lung cancer
cancer screening
health informatics
Additional relevant MeSH terms:
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Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases