Health Related Quality of Life Following Hepatectomy for Colorectal Liver Metastasis: Global and Disease Specific Changes Over Time
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 219
- 试验地点
- 12
- 主要终点
- changes in the quality of life (QoL)
研究概览
简要总结
This study is being done to learn more about health related quality of life factors in people having surgery for colorectal liver metastasis. The investigators will look at how these factors may change over time. The information gained from this study will help the investigators to understand the long-term effects that cancer treatments have on the health related quality of life of patients. This information is of high value and will help doctors talk to patients about the possible effects of their operations. While many patients live a long time after such operations, the studies that have been done do not tell the full story of what patients go through after surgery. This study will help us to understand cancer treatment from the patient's perspective. It will also help cancer patients make better decisions about their treatment options and will help them know what to expect after the operation.
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
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Colorectal cancer liver metastases (CRLM)
- •> 18 years of age
- •Absence of unresectable extrahepatic disease
- •No previous liver surgery for CRLM
- •Clinical risk score (CRS) >/= 3 or > 4 tumors
- •CRS includes the following variables;
- •Lymph node positive primary
- •Disease free interval <12 months
- •CEA level >200ng/mL (highest CEA level within 6 months prior to surgery, not including day of surgery)
- •Tumor size > 5cm
- •Number of tumors >1(based on most recent scan or pathology before liver resection)
- •Each variable is given a score of one and summed to give final CRS
- •Clinical risk score (CRS) < 3 with pending variables that cannot be determined preoperatively
- •If CRS is still < 3 postoperatively, these patients will be excluded and replaced (inevaluable).
- •Ability to read and write in English
- •Undergoing liver resection/ ablation for CRLM
- •Underwent liver resection/ ablation for CRLM, but not their primary tumors
排除标准
- •Non-English speaking
- •Inability to read and/or write
- •International Patients
- •Concurrent malignancy (excluding non-melanoma skin cancers)
研究组 & 干预措施
patients following hepatectomy
干预措施: HRQoL questionnaires. (Behavioral)
结局指标
主要结局
changes in the quality of life (QoL)
时间窗: 3 years
in patients at high risk of recurrence undergoing hepatectomy to assess health related quality of life (HRQoL) using the EORTC QLQ-C30, QLQ-LMC21 and the EuroQol EQ-5D-5L, in patients at high risk of recurrence undergoing hepatectomy for colorectal liver metastasis and to evaluate global and disease specific changes over time.
次要结局
未报告次要终点