- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07109063
- Original Trial
Psychological Distress in Breast Cancer Patients: A Cross-Sectional Study in Iraq
August 5, 2025 updated by: Hameed Adnan Hameed
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
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
500
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Anbar
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Ramadi, Anbar, Iraq, 31001
- Anbar Oncology Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Sampling Method
Non-Probability Sample
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.
Description
Inclusion Criteria:
- Diagnosed with breast cancer
- Female patients aged ≥18 years
- Receiving treatment or follow-up at Anbar Cancer Center
- Willing to provide informed consent
Exclusion Criteria:
Severe cognitive impairment
- Inability to complete questionnaires
- Refusal to participate
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
|---|
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Prevalence of Depression, Anxiety, and Sleep Disturbances among Breast Cancer Patients
Time Frame: 4 months (January 28, 2025 - May 30, 2025)
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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.
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4 months (January 28, 2025 - May 30, 2025)
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Raghda Roshdy Sayed Hussein, PhD, Clinical pharmacy, Faculty of pharmacy, Beni-Suef University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 29, 2025
Primary Completion (Actual)
May 30, 2025
Study Completion (Actual)
May 30, 2025
Study Registration Dates
First Submitted
July 29, 2025
First Submitted That Met QC Criteria
August 5, 2025
First Posted (Actual)
August 7, 2025
Study Record Updates
Last Update Posted (Actual)
August 7, 2025
Last Update Submitted That Met QC Criteria
August 5, 2025
Last Verified
August 1, 2025
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BC-Psychology-2025
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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