Depression, Anxiety, Breast Cancer, Ovarian Cancer, Cervical Cancer, Lung Cancer, Colon Cancer
Conditions
Keywords
depression, anxiety, breast cancer, validation study, female cancer patients
Brief summary
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.
Interventions
OTHERBeck Depression Inventory-21 (diagnostic survey)
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
OTHERInterview using The International Classification of Diseases in tenth edition (ICD-10) criteria
Interview using The International Classification of Diseases in tenth edition (ICD-10) criteria as a gold standard of diagnosing depression or anxiety
Sponsors
Kazakh Medical University of Continuing Education
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 65 Years
Inclusion criteria
* 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; * Russian or Kazakh language fluency; * consent to participate;
Exclusion criteria
* history of diagnosed depression or anxiety; * current use of antidepressants; * referral to palliative care
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| BDI-II Score at Baseline: | 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. |
| BDI-II Score on day 14 | 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. |
| BAI Score at Baseline | 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. |
| BAI Score Day 14 | 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. |
| ICD-10 diagnosis at baseline | 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. |
| ICD-10 diagnosis on Day 14 | 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. |
| Internal consistency of the BAI | Day 14 | 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. |
| Internal consistency of the BDI-II | Day 14 | 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 | Day 14 | 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 | Day 14 | 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 | 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. |
| Sensitivity and Specificity of the BAI at baseline | 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. |
Countries
Kazakhstan
Outcome results
None listed