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

Tele-Navigation of Lung Cancer Screening

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05021133
Enrollment
22
Registered
2021-08-25
Start date
2023-06-05
Completion date
2025-12-12
Last updated
2026-01-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Cancer

Keywords

lung cancer, cancer screening, health informatics

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.

Interventions

BEHAVIORALTele-Navi LCS

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

Sponsors

Wake Forest University Health Sciences
CollaboratorOTHER
National Institutes of Health (NIH)
CollaboratorNIH
National Cancer Institute (NCI)
CollaboratorNIH
University of Massachusetts, Worcester
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
50 Years to 77 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Completion of Tele-Navi LCS30 daysNumber of participants completed Tele-Navi LCS,

Secondary

MeasureTime frameDescription
Completion of Follow-up LCS180 daysNumber of participants who received a low-dose CT (LDCT) for LCS follow-up

Countries

United States

Participant flow

Pre-assignment details

Of 22 enrolled participants, 2 withdrew prior to the baseline survey.

Participants by arm

ArmCount
Tele-Navi LCS
Tele-Navi of LCS includes telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call
20
Total20

Baseline characteristics

CharacteristicTele-Navi LCS
Age, Continuous60.5 years
Ethnicity (NIH/OMB)
Hispanic or Latino
4 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
16 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
Race (NIH/OMB)
Asian
0 Participants
Race (NIH/OMB)
Black or African American
0 Participants
Race (NIH/OMB)
More than one race
0 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
1 Participants
Race (NIH/OMB)
Unknown or Not Reported
2 Participants
Race (NIH/OMB)
White
17 Participants
Region of Enrollment
United States
20 participants
Sex: Female, Male
Female
12 Participants
Sex: Female, Male
Male
8 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 20
other
Total, other adverse events
0 / 20
serious
Total, serious adverse events
0 / 20

Outcome results

Primary

Completion of Tele-Navi LCS

Number of participants completed Tele-Navi LCS,

Time frame: 30 days

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Tele-Navi LCSCompletion of Tele-Navi LCS20 Participants
Secondary

Completion of Follow-up LCS

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

Time frame: 180 days

Population: 2 participants moved out from the healthcare system

ArmMeasureValue (COUNT_OF_PARTICIPANTS)
Tele-Navi LCSCompletion of Follow-up LCS10 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026