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Clinical Trials/NCT05011409
NCT05011409
Completed
Not Applicable

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

Kazakh Medical University of Continuing Education2 sites in 1 country162 target enrollmentMay 17, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Depression
Sponsor
Kazakh Medical University of Continuing Education
Enrollment
162
Locations
2
Primary Endpoint
Prevalence of Depression Symptoms
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
May 17, 2021
End Date
March 10, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
Female

Investigators

Sponsor
Kazakh Medical University of Continuing Education
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Female adults with confirmed diagnosis of breast cancer within the 6 months study enrollment
  • TNM stage I-IV
  • Russian or Kazakh language proficiency
  • Ability to provide informed consent

Exclusion Criteria

  • Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
  • Current active suicidal ideation
  • Referral to palliative care

Outcomes

Primary Outcomes

Prevalence of Depression Symptoms

Time Frame: within 6 months of diagnosis

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

Time Frame: within 6 months of diagnosis

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).

Study Sites (2)

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