DepressionNCT05011409
Prevalence of Depression and Anxiety Among Breast Cancer Patients
An observational study of Depression and Anxiety, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Depression, Anxiety, Breast Cancer
- How many people
- 162 participants
- Where
- 2 sitesKazakhstan
- Study dates
- 17 May 2021to 10 Mar 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
- Current active suicidal ideation
- Referral to palliative care
Trial locations and contacts
2 sites in 1 country.
Kazakhstan2 sites
Almaty Oncology Center
Almaty, 050000
Kazakh Institute of Oncology and Radiology
Almaty, 050000
About this study
Official title: Prevalence of Depression and Anxiety Symptoms Among Newly Diagnosed Breast Cancer Patients in Almaty, Kazakhstan
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.
- Conditions
- Depression, Anxiety, Breast Cancer
- Keywords
- depression, anxiety, breast cancer, prevalence, Beck Depression Inventory, Beck Anxiety Inventory
- Medical subject headings
- Depression, Anxiety Disorders, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Measured: within 6 months of diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2021
- Study start17 May 2021
- Primary completion21 Feb 2022
- Study completion10 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 162 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kazakh Medical University of Continuing Education
- Sponsor type
- University, hospital or other
- Collaborators
- University of Malaya
- Responsible party
- Sponsor
- Investigators
- Indira A Karibayeva, MPH, Principal investigator, Kazakh Medical University of Continuing Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05011409
- Sponsor's protocol ID
- 06-2020
- Status last verified
- Mar 2022
- First submitted
- 19 May 2021
- Last updated
- 25 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: This plan is to be determined
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Depression and Anxiety Symptoms Among Newly Diagnosed Breast Cancer Patients in Almaty, Kazakhstan
- ClinicalTrials.gov ID
- NCT05011409
- Acronym / sponsor ID
- 06-2020
- Conditions
- Depression, Anxiety, Breast Cancer
- Keywords
- depression, anxiety, breast cancer, prevalence, Beck Depression Inventory, Beck Anxiety Inventory
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 162 participants (actual)
- Lead sponsor
- Kazakh Medical University of Continuing EducationUniversity, hospital or other
- Collaborators
- University of Malaya
- Study start
- 17 May 2021 (actual)
- Primary completion
- 21 Feb 2022 (actual)
- Study completion
- 10 Mar 2022 (actual)
- First posted
- 18 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (3 listed)
- Current psychotic disorder, manic episode, serious neurological disorder, intellectual disability, or developmental disorder
- Current active suicidal ideation
- Referral to palliative care
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2022.
- Individual participant dataSharing planned: Undecided. This plan is to be determined
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Indira A Karibayeva, MPH principal investigator
Kazakh Medical University of Continuing Education
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Depression and Anxiety, run by Kazakh Medical University of Continuing Education at 2 sites in Kazakhstan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Kazakhstan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of Depression Symptoms (time frame: within 6 months of diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2022; AzTrials last refreshed its copy on 8 Nov 2026.