Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery

Lung Cancer Clinical Trial

Official title:

Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery: A Multicenter, Observational, Prospective Cohort Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04759651
• Other study ID #: 2020.482.IRB1.172
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: April 2022
• Source: Koç University
• Contact: Suat Erus, MD
• Phone: +905325506947
• Email: serus[@]ku.edu.tr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1200
• Est. completion date: June 30, 2023
• Est. primary completion date: December 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients who will undergo lung resection with a pre-diagnosis of lung cancer

• Being literate or having the physical strength to answer questions.

Exclusion Criteria:

• The patient has a chronic disease such as dementia or treatment-resistant schizophrenia in which reality assessment is impaired.

• Patients who have received chemotherapy and / or radiotherapy due to their previous disease.

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasms
• Parasomnias
• Sleep Wake Disorders

Intervention

Other:
• Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR)
Sleep related quality of life questionnaire.
• Epworth Sleepiness Scale (ESS)
Subjective level of daytime sleepiness.
• Berlin Questionnaire
Evaluation of high-risk for Obstructive Sleep Apnea.
• Stop-Bang Questionnaire
Evaluation of high-risk Obstructive Sleep Apnea.
• Insomnia Questionnaire
Subjective evaluation of insomnia.
• Restless Leg Syndrome Questionnaire
Subjective evaluation of Restless Leg Syndrome.
• Zung Self-rating Depression Scale (SDS)
Subjective test for evaluation of depressive mood.
• Beck Anxiety Inventory
Subjective test for evaluation of anxiety.

Locations

Country	Name	City	State
Turkey	Koç University Hospital	Istanbul

Sponsors (6)

Lead Sponsor	Collaborator
Koç University	Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Marmara University, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey, Trakya University School of Medicine, Yedikule Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Change from baseline in Insomnia questionnaire scores	Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.	3 months
Primary	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	3 months
Secondary	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
Secondary	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".	3 months