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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2024-04893 | Registry Identifier | CTRP (Clinical Trial Reporting Program) | |
| 19-001466 | Other Identifier | Mayo Clinic Institutional Review Board |
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This study evaluates how common insomnia (difficulties with sleep) is in patients with lung cancer that has spread from where it first started (primary site) to other places in the body.
PRIMARY OBJECTIVE:
I. Evaluate the frequency of insomnia in patients with metastatic non-small cell lung cancer.
OUTLINE: This is an observational study.
Patients undergo medical chart review and complete a questionnaire on study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Observational | Patients undergo medical chart review and complete a questionnaire on study. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-Interventional Study | Other | Non-interventional study |
|
| Measure | Description | Time Frame |
|---|---|---|
| Frequency of clinically significant insomnia | Will be assessed using the Insomnia Severity Index questionnaire (ISI), is a 7-item self-report questionnaire used to gauge the perceived severity of difficulties initiating sleep, staying asleep, and early morning awakenings, satisfaction with current sleep pattern, interference with daily functioning, noticeability of impairment attributed to the sleep problem, and degree of distress or concern caused by the sleep problem. ISI score of 15 or greater will be used to categorize clinical insomnia. 0 - 7: no clinically significant insomnia, 8 - 14: subthreshold insomnia, 15 - 21: clinical insomnia (moderate severity), 22 - 28: clinical insomnia (severe). | Baseline |
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Inclusion Criteria:
Have a diagnosis of metastatic non small cell lung cancer
Exclusion Criteria:
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Patients with metastatic non small cell lung cancer recruited from Mayo Clinic Oncology Center
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| Name | Affiliation | Role |
|---|---|---|
| Konstantinos Leventakos, M.D., Ph.D. | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Recruiting | Rochester | Minnesota | 55905 | United States |
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| Label | URL |
|---|---|
| Mayo Clinic Clinical Trials | View source |
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| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |