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Completed

NCT Number: NCT05011409

Prevalence of Depression and Anxiety Among Breast Cancer Patients

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.

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Key information

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Almaty Oncology Center, Almaty, Kazakhstan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. 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.

  2. 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).

Sponsors and collaborators

Lead sponsor

Kazakh Medical University of Continuing Education

Other

Collaborators

  • University of Malaya

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 18, 2021
Registry last updated
Mar 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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