NCT05011409

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
162

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 17, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 19, 2021

Completed
3 months until next milestone

First Posted

Study publicly available on registry

August 18, 2021

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 21, 2022

Completed
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 10, 2022

Completed
Last Updated

March 25, 2022

Status Verified

March 1, 2022

Enrollment Period

9 months

First QC Date

May 19, 2021

Last Update Submit

March 24, 2022

Conditions

DepressionAnxietyBreast Cancer

Keywords

depressionanxietybreast cancerprevalenceBeck Depression InventoryBeck Anxiety Inventory

Outcome Measures

Primary Outcomes (2)

  • 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

  • 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

Study Arms (1)

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.

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale breast cancer patients, not based on the self-representation of gender identity
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study population will include breast cancer patients with confirmed diagnosis referred to the treatment to the Kazakh Institute of Oncology and Radiology and the Almaty Oncology Center

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Almaty Oncology Center

Almaty, 050000, Kazakhstan

Location

Kazakh Institute of Oncology and Radiology

Almaty, 050000, Kazakhstan

Location

MeSH Terms

Conditions

DepressionAnxiety DisordersBreast Neoplasms

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental DisordersNeoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Indira A Karibayeva, MPH

    Kazakh Medical University of Continuing Education

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 19, 2021

First Posted

August 18, 2021

Study Start

May 17, 2021

Primary Completion

February 21, 2022

Study Completion

March 10, 2022

Last Updated

March 25, 2022

Record last verified: 2022-03

Locations

KA(2)