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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

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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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Acknowledgments

Medical writing assistance was provided by ApotheCom ScopeMedical Ltd, funded by Amgen Inc. All authors had full access to the data and had final responsibility for the decision to submit the manuscript. This study was funded by Amgen Inc. Zeeshan Butt’s work on this manuscript was supported in part by grant KL2RR025740 from the National Center for Research Resources, National Institutes of Health.

Conflicts of interest

SB and AB are current employees of Amgen Inc. AO is a former employee of Amgen Inc. The remaining authors have no conflicts of interests to declare in connection with the preparation of this manuscript.

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Authors and Affiliations

  1. Department of Medical Social Sciences, Northwestern University Feinberg School of Medicine, 720 N. Lake Shore Drive, 7th Floor, Chicago, IL, 60611, USA

    David Cella & Zeeshan Butt

  2. University of Chicago Medical Center, Chicago, IL, USA

    Hedy Lee Kindler

  3. Dana-Farber Cancer Institute, Boston, MA, USA

    Charles S. Fuchs

  4. Amgen Inc, Cambridge, UK

    Sarah Bray

  5. Amgen Inc, Thousand Oaks, CA, USA

    Arie Barlev & Alan Oglesby

Authors
  1. David Cella
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  2. Zeeshan Butt
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  3. Hedy Lee Kindler
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  4. Charles S. Fuchs
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  5. Sarah Bray
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  6. Arie Barlev
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  7. Alan Oglesby
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Correspondence to David Cella.

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Cella, D., Butt, Z., Kindler, H.L. et al. 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. Qual Life Res 22, 1105–1112 (2013). https://doi.org/10.1007/s11136-012-0217-4

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