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A Longitudinal Study of Cancer-related Fatigue Among Colorectal Cancer Patients During Adjuvant Chemotherapy

6. januar 2017 oppdatert av: Hsi-Hsien Hsu, Mackay Memorial Hospital

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.

Studieoversikt

Status

Ukjent

Forhold

Detaljert beskrivelse

This study will enroll colorectal cancer patients with adjuvant chemotherapy about 1 year (estimated 60 patients). Brief fatigue inventory-Taiwanese form (BFI-T) and functional assessment of cancer therapy-general 7 (FACT-G7) will be used to evaluate patients' fatigue and quality of life. Patients will be thoroughly informed about all aspects of the study activity schedule and all regulatory requirements that must be satisfied for informed consent. Only patients who give consent to participate in this study and meet all other inclusion and exclusion criteria will be eligible to enroll into this study. The questionnaire survey will be carried out before first chemotherapy treatment (baseline), and every four chemotherapy cycles (i.e. at cycle 4, 8 and 12) after chemotherapy treatment at outpatient department (OPD) or ward during adjuvant chemotherapy treatment period. All patients will receive standard chemotherapy which continued for 24 weeks (12 cycles) or until disease progression, whichever came first. Subject demographic and disease-related information will also be collected for analysis.

Studietype

Observasjonsmessig

Registrering (Forventet)

60

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Taiwan
      • Taipei, Taiwan, 104
        • Rekruttering
        • MacKay Memorial Hospital
        • Ta kontakt med:
        • Hovedetterforsker:
          • Hsi-Hsien Hsu, M.D., Ph.D.
        • Underetterforsker:
          • Ming-Jen Chen, M.D., Ph.D.
        • Underetterforsker:
          • Chien-Kuo Liu, M.D.

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

20 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Colorectal cancer patients during adjuvant chemotherapy

Beskrivelse

Inclusion Criteria:

  1. Patients who signed the informed consent form
  2. Aged 20 years and older
  3. Patients who have been given a diagnosis of stage II-IV colorectal cancer
  4. Scheduled to receive adjuvant chemotherapy
  5. Eastern Cooperative Oncology Group (ECOG) performance status ≤ 2
  6. Able to communicate verbally and completely fill out the questionnaires

Exclusion Criteria:

  1. Female patients are pregnant or breast-feeding
  2. Patients have enrolled or have not yet completed other investigational drug trials within 30 days before screening
  3. Patients who have been given a diagnosis of cognitive impairment are unable to complete the questionnaires

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
Colorectal cancer patients
Colorectal cancer patients during adjuvant chemotherapy

Hva måler studien?

Primære resultatmål

Resultatmål
Tidsramme
Cancer-related fatigue evaluation by brief fatigue inventory-Taiwanese form(BFI-T)
Tidsramme: Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).
Change from baseline cancer-related fatigue at 12 chemotherapy cycles(24 weeks).

Sekundære resultatmål

Resultatmål
Tidsramme
Quality of life assessments by functional assessment of cancer therapy-general 7 (FACT-G7)
Tidsramme: Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).
Change from baseline quality of life at 12 chemotherapy cycles(24 weeks).

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

Mackay Memorial Hospital

Etterforskere

  • Hovedetterforsker: Hsi-Hsien Hsu, M.D., Ph.D., MacKay Memorial Hospital

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. november 2015

Primær fullføring (Forventet)

1. november 2017

Studiet fullført (Forventet)

1. februar 2018

Datoer for studieregistrering

Først innsendt

16. november 2016

Først innsendt som oppfylte QC-kriteriene

6. januar 2017

Først lagt ut (Anslag)

9. januar 2017

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

9. januar 2017

Siste oppdatering sendt inn som oppfylte QC-kriteriene

6. januar 2017

Sist bekreftet

1. januar 2017

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • CRF-CRC01

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

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Medisinsk tilstand

Legemiddelintervensjoner

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Forhold

Sjeldne sykdommer

Legemiddelintervensjoner

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