Prevalence of Depression and Anxiety Among Breast Cancer Patients

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05011409
• Other study ID #: 06-2020
• Status: Completed
• Start date: May 17, 2021
• Est. completion date: March 10, 2022

Study information

• Verified date: March 2022
• Source: Kazakh Medical University of Continuing Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 162
• Est. completion date: March 10, 2022
• Est. primary completion date: February 21, 2022
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Breast Cancer
• Breast Neoplasms
• Depression
• Depressive Disorder

Locations

Country	Name	City	State
Kazakhstan	Almaty Oncology Center	Almaty
Kazakhstan	Kazakh Institute of Oncology and Radiology	Almaty

Sponsors (2)

Lead Sponsor	Collaborator
Kazakh Medical University of Continuing Education	University of Malaya

Country where clinical trial is conducted

Kazakhstan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prevalence of Depression Symptoms	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.	within 6 months of diagnosis
Primary	Prevalence of Anxiety Symptoms	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).	within 6 months of diagnosis