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.
調査の概要
状態
条件
詳細な説明
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Taichung、台湾
- 募集
- Chung Shan Medical University Hospital
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コンタクト:
- Shih-Ming Tsao, M.D., Ph.D.
- 電話番号:34711 886-4-24739595
- メール:tsmhwy@ms24.hinet.net
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主任研究者:
- Shih-Ming Tsao, M.D., Ph.D.
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか?
デザインの詳細
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form (BFI-T)
時間枠: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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二次結果の測定
結果測定 |
時間枠 |
|---|---|
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Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
時間枠: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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
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