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.
Studienübersicht
Status
Bedingungen
Detaillierte Beschreibung
Studientyp
Einschreibung (Voraussichtlich)
Kontakte und Standorte
Studienorte
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Taipei, Taiwan, 104
- Rekrutierung
- MacKay Memorial Hospital
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Kontakt:
- Hsi-Hsien Hsu, M.D., Ph.D.
- Telefonnummer: 886-975-835784
- E-Mail: hsu5936@ms3.hinet.net
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Hauptermittler:
- Hsi-Hsien Hsu, M.D., Ph.D.
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Unterermittler:
- Ming-Jen Chen, M.D., Ph.D.
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Unterermittler:
- Chien-Kuo Liu, M.D.
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Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Probenahmeverfahren
Studienpopulation
Beschreibung
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
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
Kohorten und Interventionen
Gruppe / Kohorte |
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Colorectal cancer patients
Colorectal cancer patients during adjuvant chemotherapy
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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
Zeitfenster: 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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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Zeitfenster |
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Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Zeitfenster: 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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Mitarbeiter und Ermittler
Sponsor
Ermittler
- Hauptermittler: Hsi-Hsien Hsu, M.D., Ph.D., MacKay Memorial Hospital
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Voraussichtlich)
Studienabschluss (Voraussichtlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- CRF-CRC01
Plan für individuelle Teilnehmerdaten (IPD)
Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?
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