A Randomized Controlled Trial Assessing the Effect of Psychosocial Support on Improving Breast Cancer's Patients Response to Medical Treatment
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 160
- 试验地点
- 1
- 主要终点
- Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effect of psychosocial therapy on improving treatment response among breast cancer patients receiving chemotherapy. Participants will be randomized to receive standard medical treatment alone or combined with structured psychosocial therapy. Outcomes include treatment response, psychological well-being, and quality of life.
- Do psychosocial interventions affect the response to breast cancer treatment?
- How do societal attitudes toward psychological and social care influence the willingness of breast cancer patients in Palestine to seek psychosocial interventions?
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
- 20 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •age between 20-40 Being Palestinian female from west bank and Jerusalem
- •Diagnosed with stage I-III breast cancer.
- •Currently receiving active medical treatment.
- •Able to provide consent and participate in the intervention.
排除标准
- •being male.
- •holding other nationalities than Palestinian or living outside the westbank or Jerusalem.
- •Younger than 20 or older than 40 years old.
- •Uncooperative with interviewer
- •Terminally ill (stage IV).
- •Receiving palliative care only.
研究组 & 干预措施
Standard medical treatment
干预措施: Standard Medical Treatment (Other)
Psychosocial intervention
干预措施: Psychosocial Therapy (Behavioral)
Psychosocial intervention
干预措施: Standard Medical Treatment (Other)
结局指标
主要结局
Breast cancer-specific quality of life assessed by the Functional Assessment of Cancer Therapy - Breast (FACT-B)
时间窗: Baseline and 6 weeks
Breast cancer-specific quality of life will be assessed using the Functional Assessment of Cancer Therapy-Breast (FACT-B) questionnaire. The FACT-B is a 37-item instrument assessing physical, social/family, emotional, functional well-being, and additional breast cancer concerns. Total scores range from 0 to 148, with higher scores indicating better quality of life.
次要结局
- Anxiety level assessed by the Hospital Anxiety and Depression Scale - Anxiety subscale (HADS-A)(Baseline and 6 weeks)
- Health-related quality of life assessed by the 36-item short form health survey (SF-36)(Baseline and 6 weeks)
研究者
Dr. Hania Obaid
Consultant Psychologist and Psychotherapist
Al-Quds University