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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Lung Cancer
• Intervention / Treatment: Other: Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR); Other: Epworth Sleepiness Scale (ESS); Other: Berlin Questionnaire; Other: Stop-Bang Questionnaire; Other: Insomnia Questionnaire; Other: Restless Leg Syndrome Questionnaire; Other: Zung Self-rating Depression Scale (SDS); Other: Beck Anxiety Inventory

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.

• Study Type: Observational
• Enrollment (Anticipated): 1200

Contacts and Locations

• Study Contact: Name: Suat Erus, MD; Phone Number: +905325506947; Email: serus@ku.edu.tr
• Study Contact Backup: Name: Hale Yapıcı Eser, MD; Phone Number: +908502508250; Email: hyapici@ku.edu.tr

Study Locations

• Turkey
  • Istanbul, Turkey, 34010
    • Recruiting
    • Koç University Hospital
    • Contact: Suat Erus; Phone Number: 29300 +908502508250; Email: serus@ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

All patients meeting the criteria will be included in the study.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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	3 months

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Koç University
• Collaborators: Marmara University; Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey; Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital; Trakya University School of Medicine; Yedikule Training and Research Hospital

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Anticipated): December 31, 2022
• Study Completion (Anticipated): June 30, 2023

Study Registration Dates

• First Submitted: February 1, 2021
• First Submitted That Met QC Criteria: February 14, 2021
• First Posted (Actual): February 18, 2021

Study Record Updates

• Last Update Posted (Actual): April 15, 2022
• Last Update Submitted That Met QC Criteria: April 14, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Keywords: lung cancer; sleep disorder; thoracoscopy; robotics; vats
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Neurologic Manifestations; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms; Sleep Wake Disorders; Parasomnias
• Other Study ID Numbers: 2020.482.IRB1.172

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: 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
• IPD Sharing Time Frame: 6 months after the publication of the results
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No