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| ID | Type | Description | Link |
|---|---|---|---|
| P50CA244693 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Wake Forest University Health Sciences | OTHER |
| National Institutes of Health (NIH) | NIH |
| National Cancer Institute (NCI) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tele-Navi LCS | Other | Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tele-Navi LCS | Behavioral | Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call |
|
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Tele-Navi LCS | Number of participants completed Tele-Navi LCS, | 30 days |
| Measure | Description | Time Frame |
|---|---|---|
| Completion of Follow-up LCS | Number of participants who received a low-dose CT (LDCT) for LCS follow-up | 180 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Mayuko Ito Fukunaga, MD | University of Massachusetts, Worcester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UMass Chan Medical School | Worcester | Massachusetts | 01655 | United States |
A de-identified (by HIPAA standards) dataset may be made available to the public with PI approval.
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Of 22 enrolled participants, 2 withdrew prior to the baseline survey.
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| ID | Title | Description |
|---|---|---|
| FG000 | Tele-Navi LCS | Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Tele-Navi LCS | Tele-Navi of LCS includes telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Completion of Tele-Navi LCS | Number of participants completed Tele-Navi LCS, | Posted | Count of Participants | Participants | 30 days |
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Adverse events were monitored/assessed for each participant through study completion up to 180 days.
No adverse event
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Tele-Navi LCS | Tele-Navi of LCS includes: telehealth coaching from a Tele-Navigator for patients undergoing LCS using a video or telephone call |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Mayuko Ito Fukunaga | UMass Chan Medical School | 5088561975 | mayuko.itofukunaga@umassmed.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 11, 2023 | Aug 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Number | participants |
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| Secondary | Completion of Follow-up LCS | Number of participants who received a low-dose CT (LDCT) for LCS follow-up | 2 participants moved out from the healthcare system | Posted | Count of Participants | Participants | 180 days |
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| 0 |
| 20 |
| 0 |
| 20 |
| 0 |
| 20 |
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| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |