Clinical trial NCT04630327: Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory
Official title: Validation of the Russian and Kazakh Versions of the Beck Depression Inventory and Beck Anxiety Inventory Among Female Cancer Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Depression
Anxiety
Breast Cancer
Ovarian Cancer
Cervical Cancer
Lung Cancer
Colon Cancer
Keywords: depression
anxiety
breast cancer
validation study
female cancer patients
Lead sponsor: Kazakh Medical University of Continuing Education
Sponsor class: OTHER
First posted: 2020-11-16
Enrollment: 226
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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

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.


Eligibility criteria: 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

Primary outcomes:
measure: BDI-II Score at Baseline:
timeFrame: Baseline
measure: BDI-II Score on day 14
timeFrame: Day 14
measure: BAI Score at Baseline
timeFrame: Baseline
measure: BAI Score Day 14
timeFrame: Day 14
measure: ICD-10 diagnosis at baseline
timeFrame: Baseline
measure: ICD-10 diagnosis on Day 14
timeFrame: Day 14
measure: Internal consistency of the BAI
timeFrame: Day 14
measure: Internal consistency of the BDI-II
timeFrame: Day 14
measure: Test - retest reliability of the BDI-II questtionaire
timeFrame: Day 14
measure: Test - retest reliability of the BAI questtionaire
timeFrame: Day 14
measure: Sensitivity and Specificity of the BDI-II at baseline
timeFrame: Baseline
measure: Sensitivity and Specificity of the BAI at baseline
timeFrame: Baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Almaty
country: Kazakhstan
facility: Kazakh Scientific Research Institute of Oncology and Radiology
city: Almaty
country: Kazakhstan
facility: Almaty Oncology Center
Study officials:
affiliation: Kazakh Medical University of Continuing Education
name: Botagoz Turdaliyeva, Professor
role: STUDY_DIRECTOR
References: