A Prospective Multi-centered Observational Study on Postoperative Symptoms After Thyroidectomy (POS-T) in Patients with Thyroid Cancer
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 500
- 试验地点
- 3
- 主要终点
- THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes
研究概览
简要总结
This observational study aimed to evaluate the safety and efficacy of postoperative management in patients with thyroid cancer who received subtotal or total thyroidectomy.
详细描述
- Characteristic analysis of improvement in quality of life and symptoms after surgery in cancer patients
- Multifaceted symptom evaluation of cancer patients visiting medical institutions
- Evaluation of effectiveness and safety of treatment for postoperative symptoms in thyroid cancer patients
- Analysis of the effectiveness and prognosis of cancer-related treatment for each patient with cancer
- Analysis of prognostic factors for disease-free survival and overall survival of cancer patients
Among adult men and women aged 19 years or older who have been diagnosed with thyroid cancer, who have undergone partial or total thyroidectomy and visited the hospital for postoperative management, the characteristics of the visiting patient, quality of life, characteristics of cancer-related symptoms, and treatment effectiveness, We intend to conduct a prospective observational study to evaluate safety and its relationship with prognosis. In addition, we aim to form the basis for follow-up research through the establishment of an Oriental medicine cancer cohort and database.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •19 years of age or older
- •Those who have been confirmed to have a malignant tumor of the thyroid gland by biopsy or imaging
- •Subjects who have undergone partial thyroidectomy or total resection within 1 month
- •Those who have agreed to the implementation of Chinese medicine treatment
- •The Eastern Cooperative Oncology Group(ECOG) performance status 0-3
- •Those who understand the content of the study and agree to participate in the study
排除标准
- •○ When it is judged that other diseases other than cancer (dementia, cerebrovascular disease, severe organ failure, etc.) may have a significant effect on the decline of physical function
- •When it is judged that the life expectancy is less than 3 months and sufficient follow-up cannot be carried out
- •When emergency or major surgery or surgical intervention is required that takes precedence over postoperative treatment
- •Pregnant and lactating women
- •Other researchers who are judged to be unsuitable for research
结局指标
主要结局
THYCA-QoL score at the time of discharge (1w) of hospitalization performed for postoperative management purposes
时间窗: At the end of week 1(each cycle is 7days)
The THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors using methodologically proven standard guidelines and validated questionnaires to improve symptoms, treatment, follow-up and disease experience in thyThe THYCA-QoL is a health-related quality of life questionnaire developed for thyroid cancer and thyroid cancer survivors using methodologically proven standard guidelines and validated questionnaires to improve symptoms, treatment, follow-up and disease experience in thyroid cancer survivors. roid cancer survivors.
次要结局
- CHPIQ(At the end of Day 1, week 1, week 2)
- Oral epithelial cell-based whole genome analysis(Day 1)
- EORTC-QLQ-C30(At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month)
- MDASI-Core(At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month)
- overall survival(At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month)
- Adverse events(At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month)
- Change in THYCA-QoL over time series(At the end of Day 1, week 1, week 2, 1 month, 2 month, 3 month, 4 month, 6 month, 12 month)
- BCQ(At the end of Day 1, week 1, week 2)
研究者
Jee Young Lee
Assistant professor
CHA University