Prevalence of Depression and Anxiety Among Breast Cancer Patients

Sponsor

Kazakh Medical University of Continuing Education (Other)

Overall Status

Completed

CT.gov ID

NCT05011409

Collaborator

University of Malaya (Other)

162

Enrollment

Locations

9.8

Actual Duration (Months)

Patients Per Site

8.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety Breast Cancer

Study Design

Study Type:

Observational

Actual Enrollment :

162 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

May 17, 2021

Actual Primary Completion Date :

Feb 21, 2022

Actual Study Completion Date :

Mar 10, 2022

Arms and Interventions

Arm	Intervention/Treatment
Newly diagnosed breast cancer patients Newly diagnosed breast cancer patients referred to Kazakh Institute of Oncology and Radiology or Almaty Oncology Center will be assessed on the prevalence of depression and anxiety symptoms.

Outcome Measures

Primary Outcome Measures

Prevalence of Depression Symptoms [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 [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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