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.
Studieoversikt
Status
Forhold
Detaljert beskrivelse
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Taichung, Taiwan
- Rekruttering
- Chung Shan Medical University Hospital
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Ta kontakt med:
- Shih-Ming Tsao, M.D., Ph.D.
- Telefonnummer: 34711 886-4-24739595
- E-post: tsmhwy@ms24.hinet.net
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Hovedetterforsker:
- Shih-Ming Tsao, M.D., Ph.D.
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Deltakelseskriterier
Kvalifikasjonskriterier
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Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form (BFI-T)
Tidsramme: 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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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Tidsramme: 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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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CSMUH01
Plan for individuelle deltakerdata (IPD)
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