Development of a fatigue and functional impact scale in anemic cancer patients receiving chemotherapy

Authors

  • David Cella PhD,

    Corresponding author
    1. Center on Outcomes Research and Education, Evanston Northwestern Healthcare and Northwestern University, Evanston, Illinois
    • Center on Outcomes Research and Education, Evanston Northwestern Healthcare, Department of Psychiatry, Robert H. Lurie Comprehensive Cancer Center, Northwestern University Feinberg School of Medicine, 1001 University Place, Suite 101, Evanston, IL 60201
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    • Fax: (847) 570-7370.

    • Drs. Cella and Vadhan-Raj have received honoraria and research support from Amgen

  • Hema N. Viswanathan PhD,

    1. Global Health Economics, Amgen Inc., Thousand Oaks, California
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    • Drs. Viswanathan and Kallich are employees of Amgen and own stock in the company.

  • Ron D. Hays PhD,

    1. Division of General Internal Medicine and Health Services Research, Department of Medicine, University of California at Los Angeles, Los Angeles, California
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    • Dr. Hays was supported in part by the University of California at Los Angeles Center for Health Improvement in Minority Elderly/Resource Centers for Minority Aging Research, National Institutes of Health/National Institute on Aging/Center on Minority Health and Health Disparities, under Grant 2P30-AG-021684.

  • Tito R. Mendoza PhD,

    1. Department of Symptom Research, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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  • Kevin D. Stein PhD,

    1. Behavioral Research Center, American Cancer Society, Atlanta, Georgia
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  • David J. Pasta MS,

    1. ICON Clinical Research, San Francisco, California
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    • Mr. Pasta and Ms. Foreman are employees of ICON Clinical Research, which was paid to provide biostatistical and analytic services for the current study.

  • Aimee J. Foreman MA,

    1. ICON Clinical Research, San Francisco, California
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    • Mr. Pasta and Ms. Foreman are employees of ICON Clinical Research, which was paid to provide biostatistical and analytic services for the current study.

  • Saroj Vadhan-Raj MD,

    1. Department of Bioimmunotherapy, The University of Texas M. D. Anderson Cancer Center, Houston, Texas
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    • Drs. Cella and Vadhan-Raj have received honoraria and research support from Amgen

  • Joel D. Kallich PhD

    1. Global Health Economics, Amgen Inc., Thousand Oaks, California
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    • Drs. Viswanathan and Kallich are employees of Amgen and own stock in the company.


Abstract

BACKGROUND.

This study was conducted to develop a brief measure of fatigue and functional impact in cancer patients with anemia.

METHODS.

Data were obtained from a multisite, phase 2 study of darbepoetin-α (n = 1558). Eligible patients were ≥18 years with nonmyeloid malignancies and anemia (hemoglobin ≤11 g/dL) who were receiving chemotherapy. Items from the Functional Assessment of Cancer Therapy-Fatigue (FACT-F), Brief Fatigue Inventory (BFI), Fatigue Symptom Inventory (FSI), and items adapted from the Medical Outcomes Study SF-36 physical functioning scale were evaluated for inclusion in the measure. Items were selected by identifying the best predictors of total FACT-F scores, hemoglobin, and adjusted maximum oxygen uptake (VO2Max) in regression models. Correlations were examined between scale scores and adjusted VO2Max, hemoglobin, performance status, self-reported energy, and productivity.

RESULTS.

Data from 401 patients with complete data were used to identify 8 items for the Fatigue and Functional Impact Scale (FFIS), which was then evaluated using 1355 of the 1558 patients. The FFIS had an estimated internal consistency reliability of 0.90. The FFIS had significant correlations with the FACT-F (r = 0.94), FSI (r = 0.80), and BFI (r = 0.86), from which it was derived. The FFIS also correlated substantially with single-item measures of energy (r = 0.75) and productivity (r = 0.72).

CONCLUSIONS.

The FFIS is a reliable, brief, and practical tool that is potentially suitable for identifying fatigue and functional impact in cancer patients. Cancer 2008. © 2008 American Cancer Society.

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