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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 : December 12, 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

Tracking Information
First Submitted Date  ICMJE August 10, 2021
First Posted Date  ICMJE August 25, 2021
Last Update Posted Date December 12, 2022
Estimated Study Start Date  ICMJE March 1, 2023
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
Completion of Tele-Navi LCS [ Time Frame: 30 days ]
Number of participants completed Tele-Navi LCS,
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 19, 2021)
Completion of Follow-up LCS [ Time Frame: 180 days ]
Number of participants who received a low-dose CT (LDCT) for LCS follow-up
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)
Official Title  ICMJE Tele-Navigation of Lung Cancer Screening
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Condition  ICMJE Lung Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE 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.
Intervention: Behavioral: Tele-Navi LCS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Not yet recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2021)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE April 1, 2024
Estimated Primary Completion Date August 1, 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 81 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Joann L Wagner, MSW (508) 791-7392 Joann.Wagner@umassmed.edu
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05021133
Other Study ID Numbers  ICMJE H00022916
P50CA244693 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Current Responsible Party Mayuko Ito Fukunaga, University of Massachusetts, Worcester
Original Responsible Party Mayuko Ito Fukunaga, University of Massachusetts, Worcester, Physician (Dual)
Current Study Sponsor  ICMJE University of Massachusetts, Worcester
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE
  • Wake Forest University Health Sciences
  • National Institutes of Health (NIH)
  • National Cancer Institute (NCI)
  • Meyers Primary Care Institute
Investigators  ICMJE
Principal Investigator: Mayuko Ito Fukunaga, MD University of Massachusetts, Worcester
PRS Account University of Massachusetts, Worcester
Verification Date December 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP