Quality of Life in Patients With Hepatocellular Carcinoma
Validation of Questionnaire Module for Quality of Life and Analysis of Its Association With Clinical Outcomes; a Cohort Study in Patients With Hepatocellular Carcinoma
Hepatocellular carcinoma (HCC) is the sixth most common cancer and the second leading cause of cancer-related mortality worldwide. Despite the recent advances in the treatment of HCC, the prognosis of HCC is still poor even after curative treatment.
Performance status has shown to be associated with long-term survival and prognosis in patients with HCC, and it is one of the important factors in the Barcelona Clinic Liver Cancer (BCLC) staging system. Recently, the researches on health-related quality of life (HRQL) of cancer patients have been progressed. The most widely used surveys to assess HRQL of cancer patients are Functional Assessment of Cancer Therapy-Generic (FACT-G) and European Organisation for Research and Treatment of Cancer (EORTC) quality of life questionnaire (QLQ)-C30. Since those two are mainly about cancers in general, HCC specific surveys were developed.
The FACT-Hep questionnaire has 45-items specifically focusing on patients with hepatobiliary cancers. EORTC QLQ-hepatocellular carcinoma 18 (HCC 18) is an 18-item questionnaire designed to be used along with the EORTC QLQ-C30 for patients with HCC. An 18-item National Comprehensive Cancer Network (NCCN)-FACT Hepatobiliary-Pancreatic Symptom Index (NFHSI-18) is a specific questionnaire for advanced hepatobiliary and pancreatic cancers. However, there is no consensus whether it would be appropriate to adopt HRQL as a prognostic variable in HCC staging system. Moreover, there is limited information available about the impact of patients' HRQL on long-term outcome in patients with HCC.
Thus, in this study, the researchers will investigate whether HRQL can be an important factor in HCC staging system by testing the reliability and clinical validity of FACT-Hep, EORTC QLQ-HCC18, and NFHSI-18. Second, the investigators will evaluate the relation of HRQL with treatment efficacy, recurrence and survival outcome. Lastly, the investigators will suggest the suitable questionnaire module for patients with HCC.
Studieoversikt
Status
Forhold
Studietype
Registrering (Forventet)
Kontakter og plasseringer
Studiesteder
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Seoul, Korea, Republikken, 138-736
- Rekruttering
- Asan Medical Center
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Ta kontakt med:
- Ju Hyun Shim, MD, PhD
- Telefonnummer: +82-2-3010-3190
- E-post: s5854@medimail.co.kr
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Diagnosis of HCC
- Ability to speak, read, and write Korean
- Patient is able and willing to give informed consent
Exclusion Criteria:
- Evidence of cognitive impairment or psychiatric disturbance
- Other concurrent malignancy
- Patients involved in other clinical studies
Studieplan
Hvordan er studiet utformet?
Designdetaljer
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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Clinical validity of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18
Tidsramme: Baseline
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The FACT-Hep questionnaire consists of 18-item Hepatobiliary Subscales and 27-item FACT-G, which contains physical (7 items), social (7 items), emotional (6 items), and functional scales (7 items).
Hepatobiliary Subscale is scored 0-72, FACT-G is scored 0-108, and FACT-Hep is scored 0-180.
EORTC QLQ-HCC 18 is an 18-item questionnaire designed to be used along with the 30-item EORTC QLQ-C30.
EORTC QLQ-HCC 18 questionnaire includes 8 symptom scales such as fatigue, jaundice, nutrition, pain, fever, abdominal swelling, sexual interest, and body image.
Each item is scored 0-100 according to the EORTC guidelines.
NFHSI-18 consists of 18-item scales, and each item is scored 0-4, yielding a total between 0 and 72.
The investigators will test the validity by using the correlation and comparison of all of the questionnaire scores at baseline.
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Baseline
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Reliability of FACT-Hep, EORTC QLQ-HCC18 and NFHSI-18
Tidsramme: Baseline and at least 6 hours later
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Patients will complete the questionnaires at baseline and then will respond to the follow-up surveys at least 6 hours later the first assessment.
The investigators will examine reliability by assessing test-retest reliability of each survey after measuring the scores of questionnaires at two assessment points.
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Baseline and at least 6 hours later
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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Recurrence rates
Tidsramme: upto 3 years
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upto 3 years
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Death rates
Tidsramme: upto 3 years
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upto 3 years
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Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: Ju Hyun Shim, MD, PhD, Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
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
- AMC 2015-0229
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