The Influence of Anxiety and Depression on Survival in Nasopharyngeal Carcinoma Patients: a Prospective Observational Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Progress-free survival
研究概览
简要总结
This is a prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in nasopharyngeal carcinoma patients.
详细描述
Nasopharyngeal carcinoma (NPC) is endemic in Southern China and Southeast Asia. Radiotherapy (RT) and chemotherapy are the mainstays of therapy for NPC because these tumors are biologically highly radiosensitive and chemosensitive. Anxiety and depression symptoms were common psychological symptoms around the time of cancer diagnosis and were often persistent during cancer treatment. Psychological symptoms are associated with prolonged hospital stays, lower quality of life, and worse treatment adherence among patients with cancer. Depressive symptoms have been demonstrated to predict early mortality among patients with some kinds of cancer. But among NPC patients, the influence of anxiety and depression symptoms to long term survival have not be explored. Therefore, this prospective, observational cohort study aimed to explore the influence of anxiety and depression to long term survival in NPC patients.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with newly histologically confirmed non-keratinizing nasopharyngeal carcinoma, including WHO II or III
- •Age between 18-70
- •Male and no pregnant female
- •Patient have signed on the informed consent, and well understood the objective and procedure of this study
排除标准
- •The presence of uncontrolled life-threatening illness
- •Pregnancy or lactation
- •Patient with severe medical condition
结局指标
主要结局
Progress-free survival
时间窗: 3 years
Progress-free survival is calculated from the date of registration to the date of the first progress at any site.
次要结局
- Locoregional Relapse-Free Survival(LRFS)(3 years)
- Anxiety related measure(Baseline, completion of radiation therapy (up to 12 weeks))
- Overall Survival(OS)(3 years)
- Distress related measure(Baseline, completion of radiation therapy (up to 12 weeks))
- Distant Metastasis-Free Survival (DMFS)(3 years)
- Complete Response (CR)(completion of radiation therapy (up to 12 weeks))
- Weight Loss(Baseline, completion of radiation therapy (up to 12 weeks))
研究者
Hai-Qiang Mai,MD,PhD
Deputy Director of the Department of Nasopharyngeal Carcinoma
Sun Yat-sen University