An observational study in Lung Cancer, sponsored by Koç University. Status unknown at 1 site in Turkey (Türkiye). Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-04-15.
Sponsored by Koç University · Observational
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.
7,334 studies on the registry are indexed under Lung Neoplasms; 1,554 are open to participants now.
This study's planned enrollment of 1,200 is above the median of 190 across 1,547 observational studies indexed under Lung Neoplasms.
Browse Lung Neoplasms studies →Koç University is the lead sponsor of 109 studies on the registry; 36 are open to participants now.
Counted across the registry records on this site, refreshed daily.
All patients meeting the criteria will be included in the study.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Sleep related quality of life questionnaire.
Subjective level of daytime sleepiness.
Evaluation of high-risk for Obstructive Sleep Apnea.
Evaluation of high-risk Obstructive Sleep Apnea.
Subjective evaluation of insomnia.
Subjective evaluation of Restless Leg Syndrome.
Subjective test for evaluation of depressive mood.
Subjective test for evaluation of anxiety.
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 3 months
Change from baseline in Insomnia questionnaire scores
Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.
Time frame: 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
Time frame: 3 months
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.
Time frame: 3 months
Change from baseline in Beck Anxiety Inventory scores
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".
Time frame: 3 months
Plan to share: Yes — 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
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: 6 months after the publication of the results
Access criteria: 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.
No publications or documents are linked to this record.
This study is status unknown, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.