Validation of the Functional Assessment of Cancer Therapy-Lung Symptom Index-12 (FLSI-12)

David T. Eton, David Cella, Susan E. Yount, Kimberly M. Davis

Research output: Contribution to journalArticlepeer-review

14 Scopus citations


We tested the reliability and validity of a brief symptom index for use with patients in the advanced stages of lung cancer. The Functional Assessment of Cancer Therapy-Lung Symptom Index-12 (FLSI-12) is a brief self-report measure that combines seven items addressing symptoms common in advanced-stage lung cancer with five symptoms or concerns that are relevant to most people with advanced-stage cancer. The index was administered prospectively to 92 advanced-stage lung cancer patients beginning at the initiation of chemotherapy and for 12 consecutive weeks. Reliability, convergent and concurrent validities, and responsiveness to change were determined and a minimally important difference (MID) was estimated. The index had good internal consistency (all Cronbach's α's > 0.70), moderate to high item-to-total correlations (93% ρ's ≥ 0.30), and correlated highly with a measure of overall quality of life (ρ's ≥ 0.50). Baseline scores differentiated patients with better versus worse clinical features (p's < .05). Prospective changes in index scores were sensitive to changes in performance status ratings (p's < .05). An MID of 3-4 points was estimated by combining guideline-, distribution-, and anchor-based methods. The results show that the FLSI-12 is a psychometrically sound measure and support its use as an endpoint in clinical trials of advanced-stage lung cancer.

Original languageEnglish (US)
Pages (from-to)339-347
Number of pages9
JournalLung Cancer
Issue number3
StatePublished - Sep 2007


  • FACT
  • FLSI-12
  • Lung cancer
  • Minimally important difference
  • Patient-reported outcome
  • Quality of life
  • Symptoms
  • Validity

ASJC Scopus subject areas

  • Oncology
  • Pulmonary and Respiratory Medicine
  • Cancer Research


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