Nervous System Diseases

Behaviors and Mental Disorders

All Conditions

Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

Symptoms and General Pathology

Parasomnias

Lung Neoplasms

Sleep Wake Disorders

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Neurologic Manifestations

Mental Disorders

Psychotic Disorders

Sleep related quality of life questionnaire.

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

Epworth Sleepiness Scale (ESS)

Evaluation of high-risk for Obstructive Sleep Apnea.

Berlin Questionnaire

Evaluation of high-risk Obstructive Sleep Apnea.

Stop-Bang Questionnaire

Insomnia Questionnaire

Subjective evaluation of Restless Leg Syndrome.

Restless Leg Syndrome Questionnaire

Subjective test for evaluation of depressive mood.

Zung Self-rating Depression Scale (SDS)

Subjective test for evaluation of anxiety.

Beck Anxiety Inventory

Suat Erus, MD

Hale Yapıcı Eser, MD

Suat Erus

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.

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.

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

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

Sleep related quality of life. Score range: 5-20 points, with higher scores indicating better functional status.

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.

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.

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

Insomnia questionnaire. Score range: 0-28 points, with higher scores indicating greater insomnia severity.

Restless Leg Syndrome questionnaire. Score range: 0-4 points, with higher scores indicating more severe symptoms

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.

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".

Marmara University

Trakya University School of Medicine

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

Koç University

Skin and Connective Tissue Diseases

Anxiety Disorders

Depressive Disorder

Breast Neoplasms

Depression

Breast Diseases

Skin Diseases

Behavioral Symptoms

Mood Disorders

Newly diagnosed breast cancer patients referred to Kazakh Institute of Oncology and Radiology or Almaty Oncology Center will be assessed on the prevalence of depression and anxiety symptoms.

Indira A Karibayeva, MPH

Depression and anxiety in patients with breast cancer is serious comorbidity that affects the quality of life for patients, and their survival rates as they have poorer health outcomes. Furthermore, patients' high psychological burden is linked to higher healthcare costs. The investigation of the depression and anxiety symptoms prevalence among newly diagnosed breast cancer patients will help to navigate the health policy adjustment and psycho-social support system requirements. This study aims to investigate the prevalence of depression and anxiety symptoms among newly diagnosed breast cancer patients in Almaty, Kazakhstan, and associated risk factors.

Female breast cancer patients, not based on the self-representation of gender identity

Prevalence of Depression and Anxiety Among Breast Cancer Patients

Prevalence of Depression and Anxiety Symptoms Among Newly Diagnosed Breast Cancer Patients in Almaty, Kazakhstan

Prevalence of depression symptoms among newly diagnosed breast cancer patients according to the Beck Depression Inventory-II (BDI-II). The 21-item self-administered survey is scored on a scale of 0-3 in a list of four statements arranged in increasing severity about a particular symptom of depression. Each of the 21 items corresponding to a symptom of depression is summed to give a single score for the Beck Depression Inventory-II (BDI-II). There is a four-point scale for each item ranging from 0 to 3. p. On two items (16 and 18) there are seven options to indicate either an increase or decrease of appetite and sleep. Cut-off score guidelines for the BDI-II are given with the recommendation that thresholds be adjusted based on the characteristics of the sample, and the purpose for use of the BDI-II. Total score of 0-13 is considered minimal range, 14-19 is mild, 20-28 is moderate, and 29-63 is severe.

Prevalence of anxiety symptoms among newly diagnosed breast cancer patients according to the Beck Anxiety Inventory. The Beck Anxiety Inventory (BAI) consists of 21 self-reported items (four-point scale ranging from 0 to 3. p.) used to assess the intensity of physical and cognitive anxiety symptoms during the past week. Scores may range from 0 to 63: minimal anxiety levels (0-7), mild anxiety (8-15), moderate anxiety (16-25), and severe anxiety (26-63).

University of Malaya

Kazakh Medical University of Continuing Education

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Uterine Cervical Neoplasms

Ovarian Cancer

Ovarian Epithelial Cancer

Female cancer patients with no history of previously diagnosed depression or anxiety and who have been referred to or have been receiving treatment at Almaty Oncology Center or Kazakh Scientific Research Institute of Oncology and Radiology

Kazakh or Russian versions of the Beck Depression Inventory-21will be filled by female cancer patients

Beck Depression Inventory-21 (diagnostic survey)

Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients

Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety

Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria

Botagoz Turdaliyeva, Professor

Depression and anxiety in female patients with cancer are serious comorbidities that affect the quality of life for patients and their survival rates as they have poorer health outcomes. This validation study is a part of the study on the prevalence of depression and anxiety among breast cancer patients. This study aims to investigate the validity of the Kazakh and Russian versions of the Beck Depression Inventory (BDI-II) and Beck Anxiety Inventory (BAI) among female cancer patients in Almaty, Kazakhstan.

Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory

Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients

Non-identifiable IPD will be shared upon request with all required information

Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. 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".

The ICD-10 sets criteria for diagnosis of major depressive disorder and generalized anxiety disorder, and will be used as a gold standard of diagnosis of depression and anxiety.

Internal consistency of the subscales will be evaluated with Cronbach's alpha. Values between 0.70 and 0.90 will be considered good and greater than 0.90 will be considered excellent.

Test - retest reliability of the BDI-II questtionaire on Day 14. Test-retest reliability coefficients vary between 0 and 1, where:

1 : perfect reliability,

* 0.9: excellent reliability,
* 0.8 \< 0.9: good reliability,
* 0.7 \< 0.8: acceptable reliability,
* 0.6 \< 0.7: questionable reliability,
* 0.5 \< 0.6: poor reliability, \< 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

Test - retest reliability of the BAI questtionaire on Day 14. Test-retest reliability coefficients vary between 0 and 1, where:

1 : perfect reliability,

* 0.9: excellent reliability,
* 0.8 \< 0.9: good reliability,
* 0.7 \< 0.8: acceptable reliability,
* 0.6 \< 0.7: questionable reliability,
* 0.5 \< 0.6: poor reliability, \< 0.5: unacceptable reliability, 0: no reliability. On this scale, a correlation of .9(90%) would indicate a very high correlation (good reliability) and a value of 10% a very low one (poor reliability).

Sensitivity and Specificity of the BDI-II at baseline compared to ICD-10 criteria. Beck Depression Inventory (BDI-II) Scale is a 21-item self-reported questionnaire which measures the existence and severity of symptoms of depression. Each of the 21 items on BDI-II tool represents a depressive symptom. The symptoms are each scored on a 4-point Likert scale of 0 to 3 (0=symptom is absent; 3=symptom is severe). Scores for each symptom are added up to obtain the total scores for all 21 items. Total score ranges from 0-63; of which 0-8 is considered no depression, 0-13 is minimal depression, 14-19 is mild depression, 20-28 is moderate depression and 29-63 is severe depression.

Sensitivity and Specificity of the BAI at baseline compared to ICD-10 criteria. Beck Anxiety Inventory (BAI) is a 21-item self-reported questionnaire which measures the existenceand severity of symptoms of anxiety. Each of the 21 items on BAI tool represents an anxiety symptom. 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".

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Sleep Disorders in Patients With Suspected Lung Cancer Before and After Thoracic Surgery	NCT04759651	Lung Cancer	Functional Outc... Epworth Sleepin... Berlin Question... Stop-Bang Quest... Insomnia Questi... Restless Leg Sy... Zung Self-ratin... Beck Anxiety In...	18 Years -	Koç University
Prevalence of Depression and Anxiety Among Breast Cancer Patients	NCT05011409	Depression Anxiety Breast Cancer		18 Years - 75 Years	Kazakh Medical University of Continuing Education
Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory	NCT04630327	Depression Anxiety Breast Cancer Ovarian Cancer Cervical Cancer Lung Cancer Colon Cancer	Beck Depression... Beck Anxiety In... Interview using...	18 Years - 65 Years	Kazakh Medical University of Continuing Education

Spots Global Cancer Trial Database for beck anxiety inventory