NCT04630327|CompletedDMC
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Sponsor study identifier
observational
226
1 country
2
Study Start
January 13, 2020
Actual (reported)Primary Completion
April 28, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
May 1, 2022
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 13, 2020
Actual (reported)November 10, 2020
Actual (reported)November 16, 2020
Actual (reported)April 28, 2022
Actual (reported)May 1, 2022
Actual (reported)BDI-II Score at Baseline:
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.
Baseline
BDI-II Score on day 14
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.
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
Kazakh or Russian versions of the Beck Anxiety Inventory will be filled by female cancer patients
Adult female patients between 18 and 65 years of age with a primary diagnosis of breast cancer; ovarian cancer; cervical cancer; colon cancer; lung cancer; who have been referred to or have been receiving treatment at Almaty Oncology Center or Kazakh Scientific Research Institute of Oncology and Radiology
Kazakh Scientific Research Institute of Oncology and Radiology
Almaty, 050012, Kazakhstan
Almaty Oncology Center
Almaty, 050054, Kazakhstan
Botagoz Turdaliyeva, Professor
Kazakh Medical University of Continuing Education
226 participants (actual enrollment reported by the registry).
First Submitted
November 10, 2020
First Posted
November 16, 2020
Study Start
January 13, 2020
Actual (reported)An Integrated Genomic Approach to Assess Genetic Risk and Drug Sensitivity
Day 14
BAI Score at Baseline
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".
Baseline
BAI Score Day 14
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".
Day 14
ICD-10 diagnosis at baseline
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.
Baseline
ICD-10 diagnosis on Day 14
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.
Day 14
Internal consistency of the BAI
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.
Day 14
Internal consistency of the BDI-II
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.
Day 14
Test - retest reliability of the BDI-II questtionaire
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).
Day 14
Test - retest reliability of the BAI questtionaire
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).
Day 14
Sensitivity and Specificity of the BDI-II at baseline
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.
Baseline
Sensitivity and Specificity of the BAI at baseline
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".
Baseline
Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety
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Primary Completion
April 28, 2022
Actual (reported)Study Completion
May 1, 2022
Actual (reported)Last Updated
June 21, 2022
Record last verified: 2022-06
Non-identifiable IPD will be shared upon request with all required information
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