The Effectiveness of Psychoeducational Intervention in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed With Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 58
- 试验地点
- 1
- 主要终点
- Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
研究概览
简要总结
The goal of this clinical trial is to learn if psychoeducational intervention (tailored education, coping strategies, and guided disease disclosure) in a culturally appropriate format is beneficial in Reducing Anxiety, Depression, and Symptom Burden Among Omani Women Diagnosed with Breast Cancer. Patients receiving the intervention will be compared to Women who received standard medical care with no added psychoeducational content.
详细描述
Eligible participants were identified through the hospital's Health Information System (HIS).
Screening was conducted by the principal researcher in collaboration with a senior oncology nurse and was based on pre-established inclusion and exclusion criteria. This included reviewing the patients' diagnosis, cancer stage, psychiatric and cognitive status, and demographic characteristics.
Patients who met the criteria were approached during their chemotherapy sessions in private treatment rooms. An information sheet was provided, the purpose of the study was explained verbally in Arabic and written informed consent was obtained. Baseline assessments (Hospital Anxiety and Depression Scale (HADS) and Edmonton Symptom Assessment Scale (ESAS)) were administered immediately after consent during the same visit.
* Structure and Content of the Intervention:
- First session: duration 30-40 minutes Overview of treatment modalities (chemo, radiotherapy, hormonal therapy), side effects (e.g., fatigue, nausea, hair loss), and general coping strategies (e.g., diet, relaxation). 2nd session: 30-40 minutes Emotional preparation for mastectomy or reconstructive surgery and post-surgical care. 3rd session: 30-40 minutes Fertility, reproductive health, and strategies for managing fertility-related distress. 4th session : 30-40 minutes Managing psychological impact: stress, negative thoughts, and emotional burden. 5th session: 30-40 minutes Communication with children about the illness, including cultural and emotional aspects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age between 18 and 60 years
- •Diagnosed with Stage I-III breast cancer
- •Receiving chemotherapy at SQCCCRC during the study period
排除标准
- •Non-Omani nationality
- •Stage IV disease
- •Major psychiatric or cognitive disorders, based on medical records
结局指标
主要结局
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
时间窗: At baseline the time of the first chemotherapy session and at 9 months follow-up
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). Each subscale consists of 7 items scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety or depression.
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS)
时间窗: At baseline the time of the first chemotherapy session and at 9 months follow-up
Anxiety and depression using the Hospital Anxiety and Depression Scale (HADS) Anxiety and depression measured using the Hospital Anxiety and Depression Scale (HADS). Each subscale consists of 7 items scored from 0 to 3, with total scores ranging from 0 to 21. Higher scores indicate greater anxiety or depression.
次要结局
- Symptom burden using the Edmonton Symptom Assessment Scale (ESAS)(At baseline the time of the first chemotherapy session and at 9 months follow-up)
- Symptom burden using the Edmonton Symptom Assessment Scale (ESAS)(At baseline the time of the first chemotherapy session and at 9 months follow-up)