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Gepubliceerd in: Quality of Life Research 5/2013

01-06-2013

Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer

Auteurs: David Cella, Zeeshan Butt, Hedy Lee Kindler, Charles S. Fuchs, Sarah Bray, Arie Barlev, Alan Oglesby

Gepubliceerd in: Quality of Life Research | Uitgave 5/2013

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Abstract

Purpose

Evaluate reliability and validity of the Functional Assessment of Cancer Therapy-Hepatobiliary (FACT-Hep) questionnaire and its derivative FACT Hepatobiliary Symptom Indexes (FHSI-18 and FHSI-8) in people with metastatic pancreatic cancer.

Methods

Self-reported questionnaire data from a randomized controlled Phase II study evaluating the efficacy and safety of conatumumab (AMG 655), ganitumab (AMG 479) or placebo combined with gemcitabine were evaluated. The following were assessed: internal consistency, using Cronbach’s α; discriminant validity, comparing baseline patient-reported outcomes (PRO) scores across Eastern Cooperative Oncology Group (ECOG) performance status (PS) levels; and ability to detect change, comparing change from baseline PRO score at each cycle across PS and tumour response groups.

Results

The analysis included 96 patients. All scale scores demonstrated good internal consistency (Cronbach’s α > 0.7) and discriminant validity. Baseline scores were significantly poorer among patients with PS = 1 versus patients with PS = 0 (e.g. difference in FACT-Hep total score −17.27; p < 0.001). Ability to detect change was established for Cycles 2/3 versus baseline; PRO scores reduced in the PS-worsened group versus the PS-stable group (e.g. difference in FACT-Hep total score −24.29; p < 0.001). All PRO scale scores showed significant decline for progressive disease versus stable disease (e.g. difference in FACT-Hep total score −12.58; p = 0.004). Changes on the FHSI-18 and FHSI-8 scales were similar in magnitude whether ECOG improved or worsened.

Conclusions

FACT-Hep detects change and is a reliable and valid instrument for measuring health-related quality of life in patients with metastatic pancreatic cancer.
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Metagegevens
Titel
Validity of the FACT Hepatobiliary (FACT-Hep) questionnaire for assessing disease-related symptoms and health-related quality of life in patients with metastatic pancreatic cancer
Auteurs
David Cella
Zeeshan Butt
Hedy Lee Kindler
Charles S. Fuchs
Sarah Bray
Arie Barlev
Alan Oglesby
Publicatiedatum
01-06-2013
Uitgeverij
Springer Netherlands
Gepubliceerd in
Quality of Life Research / Uitgave 5/2013
Print ISSN: 0962-9343
Elektronisch ISSN: 1573-2649
DOI
https://doi.org/10.1007/s11136-012-0217-4

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