Health-related Quality of Life of Patients With Locally Advanced Thyroid Cancer Receiving Targeted Therapy
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- the global status of QLQ C30 questionnaire
研究概览
简要总结
The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).
详细描述
Surgical resection is the cornerstone of treatment for thyroid cancer. However, some patients present with locally advanced disease at the time of diagnosis, and they are not eligible for radical resection. Another patients still had the risk of recurrence after surgery, endocrine therapy and iodine-131 treatment. Tyrosine kinase inhibitors (TKI) have been proved to be effective in thyroid cancer patients. However, it was still unclear whether TKI drugs had influence on the HRQOL of LATC patients. The purpose of this study was to explore the changes of health-related quality of life (HRQOL) in patients with locally advanced thyroid cancer (LATC) receiving TKI drugs (anlotinib, lenvatinib, etc.).Participants enroll the study after informed consent, and quality of life will be assessed using quality of life questionnaires EORTC QLQ C30, and EORTC THY 47 before surgery, and 1,3,6 and 12 months after treatment.
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 age (18-70 year old)
- •Diagnosis of locally advanced thyroid cancer
- •Patient receiving TKI drugs.
排除标准
- •pregnancy or breastfeeding women;
- •history of other malignant diseases, unstable angina, myocardial infarction, cerebral infarction or cerebral hemorrhage within 6 months; (3) patients missing questionnaires greater than 3 times.
研究组 & 干预措施
TKI group
patients with LATC receiving Tyrosine kinase inhibitor drugs.
干预措施: Tyrosine kinase inhibitor drugs. (Drug)
结局指标
主要结局
the global status of QLQ C30 questionnaire
时间窗: 1 year
Change in global HRQOL score between baseline and at 12 months after treatment. A change of more than 10% is set as a limit for a significant change
次要结局
- Change in fatigue score(1 year)
- Adversed events of TKI.(1 year)