Development and validation of eleven symptom indexes to evaluate response to chemotherapy for advanced cancer: Measurement compliance with regulatory demands

Sarah Rosenbloom, Susan Yount, Kathleen J Yost, Debra Hampton, Diane Paul, Amy Abernethy, Paul B. Jacobsen, Karen Syrjala, Jamie Von Roenn, David Cella

Research output: Contribution to journalArticle

1 Citation (Scopus)

Abstract

Recent guidance from the United States Food and Drug Administration discusses patient-reported outcomes as endpoints in clinical trials (FDA, 2006). Using methods consistent with this guidance, we developed symptom indexes for patients with advanced cancer. Input on the most important symptoms was obtained from 533 patients recruited from National Comprehensive Cancer Network (NCCN) member institutions and four non-profit social service organizations. Diagnoses included the following 11 primary cancers: bladder, brain, breast, colorectal, head/neck, hepatobiliary/pancreatic, kidney, lung, lymphoma, ovarian and prostate. Physician experts in each of 11 diseases were also surveyed to differentiate symptoms that were predominantly disease-based from those that were predominantly treatment-induced. Results were evaluated alongside previously published indexes for 9 of these 11 advanced cancers that were created based on expert provider surveys, also at NCCN institutions (Cella et al., 2003). The 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)53-66
Number of pages14
JournalResearch in Human Capital and Development
Volume16
DOIs
StatePublished - 2008
Externally publishedYes

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chemotherapy
compliance
cancer
expert
Disease
physician's care
mobile social services
demand
index
Chemotherapy
Cancer
brain
drug
physician
Values

ASJC Scopus subject areas

  • Industrial relations
  • Political Science and International Relations
  • Demography
  • Development
  • Economics and Econometrics

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Development and validation of eleven symptom indexes to evaluate response to chemotherapy for advanced cancer : Measurement compliance with regulatory demands. / Rosenbloom, Sarah; Yount, Susan; Yost, Kathleen J; Hampton, Debra; Paul, Diane; Abernethy, Amy; Jacobsen, Paul B.; Syrjala, Karen; Roenn, Jamie Von; Cella, David.

In: Research in Human Capital and Development, Vol. 16, 2008, p. 53-66.

Research output: Contribution to journalArticle

Rosenbloom, Sarah ; Yount, Susan ; Yost, Kathleen J ; Hampton, Debra ; Paul, Diane ; Abernethy, Amy ; Jacobsen, Paul B. ; Syrjala, Karen ; Roenn, Jamie Von ; Cella, David. / Development and validation of eleven symptom indexes to evaluate response to chemotherapy for advanced cancer : Measurement compliance with regulatory demands. In: Research in Human Capital and Development. 2008 ; Vol. 16. pp. 53-66.
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