Clinical trial NCT04759651: Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery
Official title: Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery: A Multicenter, Observational, Prospective Cohort Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Lung Cancer
Keywords: sleep disorder
vats
lung cancer
robotics
thoracoscopy
Lead sponsor: Koç University
Sponsor class: OTHER
Collaborators: name: Marmara University
name: Trakya University School of Medicine
name: Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital
name: Yedikule Training and Research Hospital
name: Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
First posted: 2021-02-18
Enrollment: 1200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients meeting the criteria will be included in the study.

Brief 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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in Functional Outcome of Sleep Questionnaire scores
timeFrame: 3 months
measure: Change from baseline in Epworth Sleepiness Scale scores
timeFrame: 3 months
measure: Change from baseline in Berlin Questionnaire scores
timeFrame: 3 months
measure: Change from baseline in STOP-BANG questionnaire scores
timeFrame: 3 months
measure: Change from baseline in Insomnia questionnaire scores
timeFrame: 3 months
measure: Change from baseline in Restless Legs Syndrome questionnaire scores
timeFrame: 3 months
Secondary outcomes:
measure: Change from baseline in Zung Self-rating Depression Scale scores
timeFrame: 3 months
measure: Change from baseline in Beck Anxiety Inventory scores
timeFrame: 3 months
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Koç University Hospital
Study officials:
References: