A Study of the Correlation Between CRF, Survival and Physiological Factors in NSCLC Patients Under Chemotherapy
An Observational Study of the Correlation Between Cancer-related Fatigue, Survival and Physiological Factors in Non-Small Cell Lung Cancer (NSCLC) Patients Under Chemotherapy
Worldwide, non-small cell lung cancer (NSCLC) is one of the most common causes of cancer mortality. Also, the first leading cause of death is lung cancer in Taiwan 2012. Most patients are diagnosed at advanced stages and their median survival with supportive care is only 3-6 months. The common regimens used on advanced NSCLC treatment consists of platinum-based doublet chemotherapy, the survival benefit of which is able to extend the survival to approximately 10 months. However, disease and treatment-related toxicities in cancer patients may result in fatigue and interfered quality of life (QoL). According to the others reports, eight QoL areas including physical functioning, fatigue, pain, and appetite loss have been showed a statistically significant association with survival rate of NSCLC patients.
Cancer-related fatigue (CRF), an indicator of QoL, has been reported as the most frequent and distressing toxicity of lung cancer chemotherapy. Proposed criteria for CRF have been adopted for inclusion in the International Statistical Classification of Disease and Related Health Problems, Tenth Revision, Clinical Modification (ICD-10-CM). Therefore, more in-depth researches on CRF are needed in Taiwan.
In addition, electrolyte disturbance like hyponatremia has been reported to be counted as one of the many contributing factors for fatigue in palliative care patients and associated with poorer overall survival rate (OS) in lung cancer. Thus, the correlation between CRF and electrolyte possibly would be a strong link for physician to improve the QoL and survival rate of NSCLC patients.
The objective of this observational study is to evaluate the correlation between CRF, survival and physiological factors in NSCLC patients under chemotherapy. The study will compare the effect of QoL and CRF on survival with or without CRF treatment and investigate the correlation between the variation of CRF and physiological factors which have been examined and recorded on medical record under clinical practice. These results will supply physicians with more understanding about CRF, and help them to enhance the quality on lung 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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Taichung、台湾
- 招聘中
- Chung Shan Medical University Hospital
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接触:
- Shih-Ming Tsao, M.D., Ph.D.
- 电话号码:34711 886-4-24739595
- 邮箱:tsmhwy@ms24.hinet.net
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首席研究员:
- Shih-Ming Tsao, M.D., Ph.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 NSCLC cancer.
- Patients who are under/ or scheduled for chemotherapy treatment.
- Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2.
- Patients who are able to complete QoL questionnaires.
Exclusion Criteria:
- Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening.
学习计划
研究是如何设计的?
设计细节
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 6 chemotherapy cycles (24 weeks)
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Change from baseline cancer-related fatigue at 6 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 6 chemotherapy cycles (24 weeks)
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Change from baseline quality of life at 6 chemotherapy cycles (24 weeks)
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
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 (实际的)
研究记录更新
最后更新发布 (实际的)
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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非小细胞肺癌的临床试验
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Taichung Veterans General Hospital完全的心脏毒性 | 非小细胞肺癌(MeSH术语:Carcinoma, Non-Small-Cell Lung) | 药物相关副作用和不良反应(MeSH术语) | 表皮生长因子受体酪氨酸激酶抑制剂台湾
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Fondazione del Piemonte per l'Oncologia招聘中乳腺癌 | 卵巢癌 | 结直肠癌 | 黑色素瘤(皮肤癌) | 非小细胞肺癌(MeSH术语:Carcinoma, Non-Small-Cell Lung)意大利