Clinically meaningful changes in health-related quality of life in patients diagnosed with hepatobiliary carcinoma

J. L. Steel, D. T. Eton, D. Cella, M. C. Olek, B. I. Carr

Research output: Contribution to journalArticle

56 Scopus citations

Abstract

Background: To test the reliability, sensitivity to change in biomarkers associated with disease progression and response to treatment, and clinical meaningfulness of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) in patients with hepatobiliary carcinoma. Patients and methods: One hundred and fifty-eight patients diagnosed with hepatobiliary carcinoma were prospectively studied. Health-related quality of life (HRQL) was assessed at baseline (prior to treatment), 3-month follow-up (n=55) and 6-month follow-up (n=27) Results: The internal consistency of all the scales of the FACT-Hep were adequate at all time points (>0.75). The FACT-Hep was found to be sensitive to changes in clinical indicators (alkaline phosphate, alpha-fetoprotein, hemoglobin and survival) that reflect disease progression and response to treatment. Combined results from distribution-based and cross-sectional anchor-based analyses provide the following minimally important difference (MID) estimates: FACT-General (FACT-G) subscales = 2-3; FACT-G =6-7; Hepatobiliary Cancer Subscale = 5-6; FACT-Hep = 8-9; Trial Outcome Index = 7-8; and FACT-Hepatobiliary Symptom Index = 2-3 points. Conclusions: The FACT-Hep is a reliable instrument that is responsive to clinical indicators of disease progression and response to treatment. The MID estimates can aid interpretation of HRQL data and facilitate sample size calculation in clinical trials.

Original languageEnglish (US)
Pages (from-to)304-312
Number of pages9
JournalAnnals of Oncology
Volume17
Issue number2
DOIs
StatePublished - Feb 2006

Keywords

  • Clinical significance
  • Functional Assessment of Cancer Therapy-Hepatobiliary
  • Health-related quality of life
  • Hepatobiliary carcinoma
  • Minimally important difference

ASJC Scopus subject areas

  • Hematology
  • Oncology

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