Neurocognitive and Psychological Impact of Chemotherapy in Breast Cancer Patients: A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- chemotherapy-induced peripheral neuropathy
研究概览
简要总结
Despite growing awareness of neurocognitive and psychological complications of systemic chemotherapy administration in breast cancer, prospective observational studies evaluating such effects in Egyptian breast cancer patients-especially with pre- and post-treatment assessments-remain limited. Given the rising incidence of breast cancer in Egypt and the growing population of long-term survivors, it is essential to investigate the extent and nature of cognitive and psychological changes associated with treatment. The current study aims to fill this gap by prospectively evaluating neurological, cognitive, and psychological parameters in newly diagnosed breast cancer patients, using validated tools before and one year after treatment.
详细描述
Patient Recruitment This prospective observational study will include female breast cancer patients who will be recruited from the neuropsychiatry, Clinical Oncology, and general surgery departments, as well as from outpatient clinics at Sohag University Hospital.
Inclusion Criteria Female patients with newly diagnosed breast cancer will be included. All patients will be evaluated before the initiation of treatment and again one year after treatment completion.
Study Methodology
All enrolled patients will undergo the following assessments:
Complete History taking: thorough medical, neurological, and oncological history will be obtained, including comorbidities and current medications.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed breast cancer female patients.
- •Chemotherapy is indicated for these patients either preoperative or postoperative.
排除标准
- •known history of neurological disease.
- •presence of symptoms suggesting positive neurological disease.
结局指标
主要结局
chemotherapy-induced peripheral neuropathy
时间窗: 1 year, 2 years
FACT/GOG-Ntx questionnaire
psychological impact of chemotherapy adminstration
时间窗: 1 year, 2 years
Functional Assessment of Cancer Therapy/Gynecologic Oncology Group-Neurotoxicity (FACT/GOG-Ntx) questionnaire Total Neuropathy Score (TNS) EORTC QLQ-CIPN20 questionnaire Patient Neurotoxicity Questionnaire
次要结局
未报告次要终点
研究者
Alshaymaa Abdelghaffar
Assistant Professor
Sohag University