Lung CancerNCT05021133
Tele-Navigation of Lung Cancer Screening (Tele-Navi LCS)
A study testing Tele-Navi LCS in people with Lung Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 77 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Tele-Navi LCS
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2023to 12 Dec 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Has previous diagnosis of lung cancer
- Has active cancer diagnosis
- Is a nursing home or group care resident
- Is pregnant
Trial locations and contacts
1 site in 1 country.
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
About this study
Official title: Tele-Navigation of Lung Cancer Screening
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.
- Conditions
- Lung Cancer
- Being tested
- Tele-Navi LCS
- Keywords
- lung cancer, cancer screening, health informatics
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tele-Navi LCSBehavioural
Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call
| Study group | Role | What they receive |
|---|---|---|
| Tele-Navi LCS | Other | Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS Receives: Behavioral: Tele-Navi LCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
Completion of Tele-Navi LCS
Number of participants completed Tele-Navi LCS,
Measured: 30 days
Secondary outcomes (1)
Completion of Follow-up LCS
Number of participants who received a low-dose CT (LDCT) for LCS follow-up
Measured: 180 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2021
- Study start5 Jun 2023
- Primary completion11 Aug 2023
- Study completion12 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Collaborators
- Wake Forest University Health Sciences, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Responsible party
- Principal investigator, Mayuko Ito Fukunaga, University of Massachusetts, Worcester
- Investigators
- Mayuko Ito Fukunaga, MD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05021133
- Sponsor's protocol ID
- H00022916
- Other IDs
- P50CA244693
- Status last verified
- Dec 2025
- First submitted
- 10 Aug 2021
- Last updated
- 8 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: A de-identified (by HIPAA standards) dataset may be made available to the public with PI approval.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tele-Navigation of Lung Cancer Screening
- ClinicalTrials.gov ID
- NCT05021133
- Acronym / sponsor ID
- H00022916
- Conditions
- Lung Cancer
- Keywords
- lung cancer, cancer screening, health informatics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- Wake Forest University Health Sciences, National Institutes of Health (NIH), National Cancer Institute (NCI)
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 11 Aug 2023 (actual)
- Study completion
- 12 Dec 2025 (actual)
- First posted
- 25 Aug 2021 (actual)
- Results
- Posted 29 Aug 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Screening
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tele-Navi LCS | Other | Behavioral: Tele-Navi LCSTele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS |
Who may qualify
- Ages
- 50 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Has previous diagnosis of lung cancer
- Has active cancer diagnosis
- Is a nursing home or group care resident
- Is pregnant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tele-Navi LCSTele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call | Behavioural | Tele-Navi LCS |
Primary outcome
Completion of Tele-Navi LCS
Time frame: 30 days
Number of participants completed Tele-Navi LCS,
1 secondary outcome
Completion of Follow-up LCS
Time frame: 180 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. A de-identified (by HIPAA standards) dataset may be made available to the public with PI approval.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mayuko Ito Fukunaga, MD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tele-Navi LCS in people with Lung Cancer, run by University of Massachusetts, Worcester at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Aug 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Completion of Tele-Navi LCS (time frame: 30 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jan 2026.