A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy
Worldwide, nearly 1.25 million patients are diagnosed with and more than 600,000 patients die from colorectal cancer each year. The third leading cause of death is colorectal cancer in Taiwan 2012. The current treatments for colorectal cancer including surgery, chemotherapy and/or radiotherapy are prescribed to improve survival and lower the risk of recurrence. However, disease and treatment-related toxicities in cancer patients may result in fatigue and interfered quality of life (QoL). Previous studies have reported that cancer-related fatigue (CRF) is the most common symptom experienced by patients at all stage of diseases, it can occur during treatment, in advanced disease and in disease-free survivors; the prevalence of fatigue is reported to be between 59-96% in patients undergoing chemotherapy, 65-100% in patients receiving radiation therapy, and 30% in long term survivors. Also, CRF has been reported as the most frequent and distressing toxicity of colon and rectal chemotherapy. The National Comprehensive Cancer Network (NCCN) has published guidelines for the definition of CRF as ''a persistent subjective sense of physical, emotional, and/or cognitive tiredness or exhaustion related to cancer or cancer treatment that is not proportional to recent activity and that significantly interferes with usual functioning." Besides, CRF could dynamically change with the interactions among disease progression, treatment regimen, tumor site, nutrition, infection or other factors. Therefore, to minimize the impact of CRF on cancer patients, more in-depth researches on CRF are needed.
The aim of this longitudinal study is to examine the dynamic changes, correlated factors and QoL of CRF among colorectal cancer patients during adjuvant chemotherapy. Furthermore, the results will supply physicians with more understanding about CRF, and help them to enhance the quality on cancer care to being perfected in the future.
研究概览
地位
条件
详细说明
研究类型
注册 (预期的)
联系人和位置
学习地点
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Taipei、台湾、104
- 招聘中
- MacKay Memorial Hospital
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接触：
- Hsi-Hsien Hsu, M.D., Ph.D.
- 电话号码：886-975-835784
- 邮箱：hsu5936@ms3.hinet.net
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首席研究员：
- Hsi-Hsien Hsu, M.D., Ph.D.
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副研究员：
- Ming-Jen Chen, M.D., Ph.D.
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副研究员：
- Chien-Kuo Liu, M.D.
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
- Patients who signed the informed consent form
- Aged 20 years and older
- Patients who have been given a diagnosis of stage II-IV colorectal cancer
- Scheduled to receive adjuvant chemotherapy
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
- Able to communicate verbally and completely fill out the questionnaires
Exclusion Criteria:
- Female patients are pregnant or breast-feeding
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening
- Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
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Colorectal cancer patients
Colorectal cancer patients during adjuvant chemotherapy
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
大体时间：Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).
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Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
大体时间：Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).
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Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).
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合作者和调查者
调查人员
- 首席研究员：Hsi-Hsien Hsu, M.D., Ph.D.、MacKay Memorial Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (预期的)
研究完成 (预期的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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