Lung CancerNCT04759651
Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery
An observational study of Lung Cancer, run by Koç University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR), Epworth Sleepiness Scale (ESS) and Berlin Questionnaire
- How many people
- 1,200 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2021to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients meeting the criteria will be included in the study.
Who may be able to join
- Patients who will undergo lung resection with a pre-diagnosis of lung cancer
- Being literate or having the physical strength to answer questions.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koç University Hospital
Istanbul, 34010
Suat Erus, +908502508250 ext. 29300, serus@ku.edu.tr
About this study
Official title: 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.
Read the 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.
- Conditions
- Lung Cancer
- Being tested
- Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR), Epworth Sleepiness Scale (ESS), Berlin Questionnaire, Stop-Bang Questionnaire, Insomnia Questionnaire
- Keywords
- sleep disorder, vats, lung cancer, robotics, thoracoscopy
- Medical subject headings
- Lung Neoplasms, Sleep Wake Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 QuestionnaireOther
Evaluation of high-risk for Obstructive Sleep Apnea.
Stop-Bang QuestionnaireOther
Evaluation of high-risk Obstructive Sleep Apnea.
Insomnia QuestionnaireOther
Subjective evaluation of insomnia.
Restless Leg Syndrome QuestionnaireOther
Subjective evaluation of Restless Leg Syndrome.
Zung Self-rating Depression Scale (SDS)Other
Subjective test for evaluation of depressive mood.
Beck Anxiety InventoryOther
Subjective test for evaluation of anxiety.
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 3 months
Change from baseline in Insomnia questionnaire scores
Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.
Measured: 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
Measured: 3 months
Secondary outcomes (2)
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.
Measured: 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".
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2021
- Study start1 Jun 2021
- Primary completion31 Dec 2022 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koç University
- Sponsor type
- University, hospital or other
- Collaborators
- Marmara University, Trakya University, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Yedikule Training and Research Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04759651
- Sponsor's protocol ID
- 2020.482.IRB1.172
- Status last verified
- Apr 2022
- First submitted
- 1 Feb 2021
- Last updated
- 15 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery: A Multicenter, Observational, Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT04759651
- Acronym / sponsor ID
- 2020.482.IRB1.172
- Conditions
- Lung Cancer
- Keywords
- sleep disorder, vats, lung cancer, robotics, thoracoscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,200 participants (estimated)
- Lead sponsor
- Koç UniversityUniversity, hospital or other
- Collaborators
- Marmara University, Trakya University, Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital, Yedikule Training and Research Hospital, Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 18 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients meeting the criteria will be included in the study.
Key inclusion criteria (2 listed)
- Patients who will undergo lung resection with a pre-diagnosis of lung cancer
- Being literate or having the physical strength to answer questions.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR)Sleep related quality of life questionnaire. | Other | – |
| Epworth Sleepiness Scale (ESS)Subjective level of daytime sleepiness. | Other | – |
| Berlin QuestionnaireEvaluation of high-risk for Obstructive Sleep Apnea. | Other | – |
| Stop-Bang QuestionnaireEvaluation of high-risk Obstructive Sleep Apnea. | Other | – |
| Insomnia QuestionnaireSubjective evaluation of insomnia. | Other | – |
| Restless Leg Syndrome QuestionnaireSubjective evaluation of Restless Leg Syndrome. | Other | – |
| Zung Self-rating Depression Scale (SDS)Subjective test for evaluation of depressive mood. | Other | – |
| Beck Anxiety InventorySubjective test for evaluation of anxiety. | Other | – |
Primary outcome
Change from baseline in Functional Outcome of Sleep Questionnaire scores
Time frame: 3 months
Sleep related quality of life. Score range: 5-20 points, with higher scores indicating better functional status.
Change from baseline in Epworth Sleepiness Scale scores
Time frame: 3 months
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.
Change from baseline in Berlin Questionnaire scores
Time frame: 3 months
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.
Change from baseline in STOP-BANG questionnaire scores
Time frame: 3 months
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
Change from baseline in Insomnia questionnaire scores
Time frame: 3 months
Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.
Change from baseline in Restless Legs Syndrome questionnaire scores
Time frame: 3 months
Restless Leg Syndrome questionnaire. Score range: 0-4 points, with higher scores indicating more severe symptoms
2 secondary outcomes
Change from baseline in Zung Self-rating Depression Scale scores
Time frame: 3 months
Change from baseline in Beck Anxiety Inventory scores
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2022.
- Individual participant dataSharing planned: 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
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lung Cancer, run by Koç University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Suat Erus, MD (+905325506947, serus@ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Functional Outcome of Sleep Questionnaire scores (time frame: 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Apr 2022.