Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer

David Cella*, Sarah K. Rosenbloom, Jennifer L. Beaumont, Susan E. Yount, Diane Paul, Debra Hampton, Amy P. Abernethy, Paul B. Jacobsen, Karen Syrjala, Jamie H. Von Roenn

*Corresponding author for this work

Research output: Contribution to journalReview article

26 Scopus citations

Abstract

Recent guidance from the FDA discusses patient-reported outcomes as end points in clinical trials. Using methods consistent with this guidance, the authors developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from NCCN Member Institutions and 4 nonprofit social service organizations. Diagnoses included bladder, brain, breast, colorectal, head and neck, hepatobiliary/ pancreatic, kidney, lung, ovarian, and prostate cancers and lymphoma. Physician experts in each of these diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results are evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also implemented at NCCN Member Institutions. Final results are 11 symptom indexes that reflect the highest priorities of people affected by these 11 advanced cancers and the experienced perspective of the people who provide their medical treatment. Beyond the clinical value of such indexes, they may also contribute significantly to satisfying regulatory requirements for a standardized tool to evaluate drug efficacy with respect to symptomatology.

Original languageEnglish (US)
Pages (from-to)268-278
Number of pages11
JournalJNCCN Journal of the National Comprehensive Cancer Network
Volume9
Issue number3
DOIs
StatePublished - Mar 1 2011

Keywords

  • Advanced cancer
  • Health-related quality of life
  • Measurement
  • Patient-centered
  • Symptom index

ASJC Scopus subject areas

  • Oncology

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    Cella, D., Rosenbloom, S. K., Beaumont, J. L., Yount, S. E., Paul, D., Hampton, D., Abernethy, A. P., Jacobsen, P. B., Syrjala, K., & Von Roenn, J. H. (2011). Development and validation of 11 symptom indexes to evaluate response to chemotherapy for advanced cancer. JNCCN Journal of the National Comprehensive Cancer Network, 9(3), 268-278. https://doi.org/10.6004/jnccn.2011.0026