Breast CancerNCT07109063
Psychological Distress in Breast Cancer Patients: A Cross-Sectional Study in Iraq
An observational study of Breast Cancer and Psychological Distress, run by Hameed Adnan Hameed at 1 site in Iraq.
Trial summary
This cross-sectional study aims to assess the psychological distress, including depression, anxiety, and stress, among breast cancer patients in Anbar, Iraq. Data were collected using validated questionnaires to evaluate mental health status and associated clinical and demographic factors. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Psychological Distress, Depression Anxiety Disorder
- How many people
- 500 participants
- Where
- 1 siteIraq
- Study dates
- 29 Jan 2025to 30 May 2025
- 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 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: The study population consists of female breast cancer patients attending Anbar Cancer Center in Iraq for treatment or follow-up during the study period.
Who may be able to join
- Diagnosed with breast cancer
- Female patients aged ≥18 years
- Receiving treatment or follow-up at Anbar Cancer Center
- Willing to provide informed consent
Who cannot join
- Severe cognitive impairment
- Inability to complete questionnaires
- Refusal to participate
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Psychosocial and Clinical Predictors of Depression, Anxiety, and Stress Among Breast Cancer Patients in Iraq: A Multivariate and Path Modeling Analysis
This cross-sectional study aims to assess the psychological distress, including depression, anxiety, and stress, among breast cancer patients in Anbar, Iraq. Data were collected using validated questionnaires to evaluate mental health status and associated clinical and demographic factors. The findings will provide insights to improve psychosocial support and patient care in oncology settings
Read the detailed description
This research is a cross-sectional study conducted to investigate the prevalence and severity of psychological distress, including depression, anxiety, and stress, among breast cancer patients in Anbar, Iraq. The study utilized standardized and validated questionnaires (such as PHQ-9, GAD-7, and Perceived Stress Scale) to assess the mental health status of participants. Data on clinical variables, cancer stage, treatment modalities, and socio-demographic characteristics were collected to identify potential predictors of psychological distress. Statistical analyses were performed to explore associations between psychological outcomes and clinical or demographic factors. The results of this study aim to provide evidence to guide psychosocial interventions and enhance patient care strategies in oncology centers.
- Keywords
- Mental Health, Oncology Patients, Cross-Sectional Study, Iraq, Psychosocial Support
- Medical subject headings
- Breast Neoplasms, Psychological Well-Being
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 |
|---|---|---|
| Breast Cancer Patients Group | This group includes all female patients diagnosed with breast cancer who participated in the cross-sectional survey assessing depression, anxiety, and stress in Anbar, Iraq. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of Depression, Anxiety, and Sleep Disturbances among Breast Cancer Patients
Assessment of psychological distress levels (depression, anxiety, and sleep quality) using PHQ-9, GAD-7, and Pittsburgh Sleep Quality Index questionnaires to evaluate mental health outcomes in breast cancer patients.
Measured: 4 months (January 28, 2025 - May 30, 2025)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2025
- Study start29 Jan 2025
- Primary completion30 May 2025
- Study completion30 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hameed Adnan Hameed
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Hameed Adnan Hameed, Al-Maarif University College
- Investigators
- Raghda Roshdy Sayed Hussein, PhD, Clinical pharmacy, Principal investigator, Faculty of pharmacy, Beni-Suef University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07109063
- Sponsor's protocol ID
- BC-Psychology-2025
- Status last verified
- Aug 2025
- First submitted
- 29 Jul 2025
- Last updated
- 7 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared because the dataset contains sensitive patient information and there are no current agreements or resources to enable secure data sharing while ensuring confidentiality
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychosocial and Clinical Predictors of Depression, Anxiety, and Stress Among Breast Cancer Patients in Iraq: A Multivariate and Path Modeling Analysis
- ClinicalTrials.gov ID
- NCT07109063
- Acronym / sponsor ID
- BC-Psychology-2025
- Keywords
- Mental Health, Oncology Patients, Cross-Sectional Study, Iraq, Psychosocial Support
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Hameed Adnan HameedUniversity, hospital or other
- Study start
- 29 Jan 2025 (actual)
- Primary completion
- 30 May 2025 (actual)
- Study completion
- 30 May 2025 (actual)
- First posted
- 7 Aug 2025 (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.
This cross-sectional study aims to assess the psychological distress, including depression, anxiety, and stress, among breast cancer patients in Anbar, Iraq. Data were collected using validated questionnaires to evaluate mental health status and associated clinical and demographic factors. The findings will provide insights to improve psychosocial support and patient care in oncology settings
Detailed description
This research is a cross-sectional study conducted to investigate the prevalence and severity of psychological distress, including depression, anxiety, and stress, among breast cancer patients in Anbar, Iraq. The study utilized standardized and validated questionnaires (such as PHQ-9, GAD-7, and Perceived Stress Scale) to assess the mental health status of participants. Data on clinical variables, cancer stage, treatment modalities, and socio-demographic characteristics were collected to identify potential predictors of psychological distress. Statistical analyses were performed to explore associations between psychological outcomes and clinical or demographic factors. The results of this study aim to provide evidence to guide psychosocial interventions and enhance patient care strategies in oncology centers.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Breast Cancer Patients Group | – | –This group includes all female patients diagnosed with breast cancer who participated in the cross-sectional survey assessing depression, anxiety, and stress in Anbar, Iraq. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- The study population consists of female breast cancer patients attending Anbar Cancer Center in Iraq for treatment or follow-up during the study period.
Key inclusion criteria (4 listed)
- Diagnosed with breast cancer
- Female patients aged ≥18 years
- Receiving treatment or follow-up at Anbar Cancer Center
- Willing to provide informed consent
Key exclusion criteria (3 listed)
- Severe cognitive impairment
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, Anxiety, and Sleep Disturbances among Breast Cancer Patients
Time frame: 4 months (January 28, 2025 - May 30, 2025)
Assessment of psychological distress levels (depression, anxiety, and sleep quality) using PHQ-9, GAD-7, and Pittsburgh Sleep Quality Index questionnaires to evaluate mental health outcomes in breast cancer patients.
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 7 Aug 2025.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared because the dataset contains sensitive patient information and there are no current agreements or resources to enable secure data sharing while ensuring confidentiality
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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.
Raghda Roshdy Sayed Hussein, PhD, Clinical pharmacy principal investigator
Faculty of pharmacy, Beni-Suef University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Psychological Distress, run by Hameed Adnan Hameed at 1 site in Iraq.
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 7 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Iraq. 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, Anxiety, and Sleep Disturbances among Breast Cancer Patients (time frame: 4 months (January 28, 2025 - May 30, 2025)). 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 7 Aug 2025; AzTrials last refreshed its copy on 7 Nov 2026.