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| Name | Class |
|---|---|
| Marmara University | OTHER |
| Trakya University | OTHER |
| Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital | OTHER |
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The main aim of this study is to prospectively evaluate the occurrence of sleep disorders in patients undergoing thoracic surgery due to the preliminary diagnosis of lung cancer. Secondary aims include anxiety, depressive mood and functional outcomes before and 3 months after the intervention.
Cancer surgery is one of the traumas that affect human life, starting from diagnostic procedures, along with the recovery process. Although 5-year survival in lung cancer has increased to 60%, there is a general prejudice that lung cancer has a poor prognosis. A preliminary diagnosis of a such condition has consequently a negative effect on the mood and sleep patterns of the patients, starting already from the beginning of the diagnostic procedures. In our study, we want to evaluate the occurrence of sleep disorders, anxiety, depressive mood and functional outcomes before and 3 months after the surgical intervention. This would also help us to better identify the patients in need for professional support for sleep disorders as well as psychiatric conditions, and thus, a better management of patients with lung cancer.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR) | Other | Sleep related quality of life questionnaire. | ||
| Epworth Sleepiness Scale (ESS) | Other | Subjective level of daytime sleepiness. | ||
| Berlin Questionnaire | Other | Evaluation of high-risk for Obstructive Sleep Apnea. | ||
| Stop-Bang Questionnaire | Other | Evaluation of high-risk Obstructive Sleep Apnea. | ||
| Insomnia Questionnaire | Other | Subjective evaluation of insomnia. | ||
| Restless Leg Syndrome Questionnaire |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Functional Outcome of Sleep Questionnaire scores | Sleep related quality of life. Score range: 5-20 points, with higher scores indicating better functional status. | 3 months |
| Change from baseline in Epworth Sleepiness Scale scores | Excessive daytime sleepiness. Score range: 0-24 points, with higher scores indicating greater daytime sleepiness. Scores ≥11 are generally considered to be abnormal, or positive for excessive daytime sleepiness. | 3 months |
| Change from baseline in Berlin Questionnaire scores | High-risk Obstructive Sleep Apnea. Patients can be classified into High Risk or Low Risk based on their responses to the individual items and their overall scores in the symptom categories. | 3 months |
| Change from baseline in STOP-BANG questionnaire scores | High-risk Obstructive Sleep Apnea. Score range: 0-8 points, patients with a STOP-Bang score of 0 to 2 can be classified as low risk for moderate to severe OSA whereas those with a score of 5 to 8 can be classified as high risk for moderate to severe OSA. The STOP-BANG is an assessment tool used to help diagnose Obstructive Sleep Apnea | 3 months |
| Change from baseline in Insomnia questionnaire scores | Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity. | 3 months |
| Change from baseline in Restless Legs Syndrome questionnaire scores | Restless Leg Syndrome questionnaire. Score range: 0-4 points, with higher scores indicating more severe symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Zung Self-rating Depression Scale scores | Zung Self-rating Depression Scale. Score range: 0-80 points, most people with depression score between 50 and 69, while a score of 70 and above indicates severe depression. | 3 months |
| Change from baseline in Beck Anxiety Inventory scores |
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Inclusion Criteria:
Exclusion Criteria:
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All patients meeting the criteria will be included in the study.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Suat Erus, MD | Contact | +905325506947 | serus@ku.edu.tr | |
| Hale Yapıcı Eser, MD | Contact | +908502508250 | hyapici@ku.edu.tr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Koç University Hospital | Recruiting | Istanbul | 34010 | Turkey (Türkiye) |
Data collected for the study, including de-identified individual participant data will be made available to others within 6 months after the publication of this article, as will additional related documents (study protocol, statistical analysis plan, and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author, and with a signed data access agreement
6 months after the publication of the results
Data collected for the study, including de-identified individual participant data will be made available to others within 6 months after the publication of this article, as will additional related documents (study protocol, statistical analysis plan, and informed consent form), for academic purposes (e.g., meta-analyses), upon request to the corresponding author (serus@ku.edu.tr), and with a signed data access agreement.
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| Yedikule Training and Research Hospital |
| OTHER |
| Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey | OTHER |
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Subjective evaluation of Restless Leg Syndrome. |
| Zung Self-rating Depression Scale (SDS) | Other | Subjective test for evaluation of depressive mood. |
| Beck Anxiety Inventory | Other | Subjective test for evaluation of anxiety. |
| 3 months |
Self-rating anxiety scale. Score range: 0-63 points, a total score of 0 - 7 is interpreted as a "Minimal" level of anxiety; 8 - 15 as "Mild"; 16 - 25 as "Moderate", and; 26 - 63 as "Severe". |
| 3 months |
| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| D012893 | Sleep Wake Disorders |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D009422 | Nervous System Diseases |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001523 | Mental Disorders |
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