Comprehensive Study on the Quality of Life in Cervical Cancer Patients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- Scores from EORTC QLQ-C30
研究概览
简要总结
This is prospective cohort study. All the patients with primary cervical cancer in the future three years in Peking Union Medical College Hospital will be included in this study. Before and after the major therapy (including at least radical hysterectomy and/or radiotherapy), the patients accept (1) the questionnaires survey about quality of life; (2) urodynamic testing; (3) rectum dynamics testing and (4) ovarian reserve function. The survival outcomes (disease-free survival and overall survival) will be supplemented as secondary objectives.
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Primary uterine cervical carcinomas
- •Aged 18 or older
- •Accepting major therapy (including at least radical hysterectomy and/or radiotherapy) in the study center
- •Informed consents delivered
排除标准
- •Not meeting any of the inclusion criteria
- •Not accepting any of the four kinds of evaluations for quality of life
- •Recurrent patients
- •Not achieving response after above major therapy
结局指标
主要结局
Scores from EORTC QLQ-C30
时间窗: Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.
Scores calculated from European Organization for Research and Treatment of Cancer (EORTC) QLQ-C30
Scores from EORTC QLQ-CX24
时间窗: Change from the baseline of four weeks before major therapy at following-up. The standard scores ranges from 0 to 100, and the higher score, the more inferior quality of life.
Scores calculated from EORTC QLQ-CX24
次要结局
- Concentration of follicle-stimulating hormone(Change from the baseline of four weeks before major therapy at following-up)
- Concentration of estradiol(Change from the baseline of four weeks before major therapy at following-up)
- Bladder capacity at the first void sense(Change from the baseline of four weeks before major therapy at following-up)
- Concentration of anti-mullerian hormone(Change from the baseline of four weeks before major therapy at following-up)
- Residual urine volume(Change from the baseline of four weeks before major therapy at following-up)
- Average flow rate(Change from the baseline of four weeks before major therapy at following-up)
- Bladder pressure at maximun flow rate(Change from the baseline of four weeks before major therapy at following-up)
- Bladder compliance at strong desire to void(Change from the baseline of four weeks before major therapy at following-up)
- Concentration of inhibin B(Change from the baseline of four weeks before major therapy at following-up)
- Maximun flow rate(Change from the baseline of four weeks before major therapy at following-up)
- Bladder capacity at normal desire to void(Change from the baseline of four weeks before major therapy at following-up)
- Bladder capacity at strong desire to void(Change from the baseline of four weeks before major therapy at following-up)
- Detrusor pressure at maximun flow rate(Change from the baseline of four weeks before major therapy at following-up)
- Detrusor compliance at strong desire to void(Change from the baseline of four weeks before major therapy at following-up)
- Anal sphincter pressure(Change from the baseline of four weeks before major therapy at following-up)
研究者
Lei Li
Professor
Peking Union Medical College Hospital