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

NCT ID: NCT04759651

Last Updated: 2022-04-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

1200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2023-06-30

Brief Summary

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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

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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

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Lung Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Interventions

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Functional Outcome of Sleep Questionnaire Turkish version (FOSQ-TR)

Sleep related quality of life questionnaire.

Intervention Type OTHER

Epworth Sleepiness Scale (ESS)

Subjective level of daytime sleepiness.

Intervention Type OTHER

Berlin Questionnaire

Evaluation of high-risk for Obstructive Sleep Apnea.

Intervention Type OTHER

Stop-Bang Questionnaire

Evaluation of high-risk Obstructive Sleep Apnea.

Intervention Type OTHER

Insomnia Questionnaire

Subjective evaluation of insomnia.

Intervention Type OTHER

Restless Leg Syndrome Questionnaire

Subjective evaluation of Restless Leg Syndrome.

Intervention Type OTHER

Zung Self-rating Depression Scale (SDS)

Subjective test for evaluation of depressive mood.

Intervention Type OTHER

Beck Anxiety Inventory

Subjective test for evaluation of anxiety.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Marmara University

OTHER

Sponsor Role collaborator

Trakya University School of Medicine

UNKNOWN

Sponsor Role collaborator

Istanbul Sureyyapasa Chest Diseases and Chest Surgery Training and Research Hospital

OTHER

Sponsor Role collaborator

Yedikule Training and Research Hospital

OTHER

Sponsor Role collaborator

Sultan Abdulhamid Han Training and Research Hospital, Istanbul, Turkey

OTHER

Sponsor Role collaborator

Koç University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Koç University Hospital

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Suat Erus, MD

Role: CONTACT

+905325506947

Hale Yapıcı Eser, MD

Role: CONTACT

+908502508250

Facility Contacts

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Suat Erus

Role: primary

+908502508250 ext. 29300

Other Identifiers

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2020.482.IRB1.172

Identifier Type: -

Identifier Source: org_study_id

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