Psychometric evaluation of the FACT Colorectal Cancer Symptom Index (FCSI-9): reliability, validity, responsiveness, and clinical meaningfulness

Oncologist. 2010;15(3):308-16. doi: 10.1634/theoncologist.2009-0034. Epub 2010 Feb 26.


Background: Patient-reported outcomes (PROs) are essential for evaluating treatment effects on health-related quality of life and symptoms from the patient's perspective. This study sought to evaluate the psychometric properties of the nine-item Functional Assessment of Cancer Therapy/National Comprehensive Cancer Network Colorectal Cancer Symptom Index (FCSI-9) in a metastatic colorectal cancer (mCRC) population.

Methods: The FCSI-9 and EQ-5D were administered every 2-4 weeks to mCRC subjects in a phase III clinical trial. Three hundred ninety-one mCRC subjects completed the questionnaires at baseline and at least one follow-up assessment. Internal consistency reliability, test-retest reliability, construct validity, known groups validity, responsiveness, and the minimum important difference (MID) of the FCSI-9 were evaluated.

Results: The internal consistency and test-retest reliability of the FCSI-9 were acceptable (0.81 and 0.76, respectively). Construct validity was supported based on moderate correlations with the EQ-5D. Known groups validity was evaluated by examining the FCSI-9 scores of subjects categorized by their Eastern Cooperative Oncology Group performance status (PS) score. Subjects with better PS scores reported significantly higher FCSI-9 scores than those with lower PS scores at both baseline and week 8. Responsiveness, as measured by Guyatt's statistic, was 0.77 from baseline to week 8 and 0.60 from week 4 to week 12. Considering all data together, the MID of the FCSI-9 is estimated to be in the range of 1.5-3.0 points.

Conclusion: Results provide preliminary evidence of the reliability, validity, and responsiveness of the FCSI-9.

Publication types

  • Clinical Trial, Phase III
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Aged
  • Antibodies, Monoclonal / therapeutic use
  • Colorectal Neoplasms / drug therapy
  • Colorectal Neoplasms / psychology*
  • Female
  • Humans
  • Male
  • Outcome Assessment, Health Care / methods*
  • Palliative Care
  • Panitumumab
  • Patient Participation
  • Patient Satisfaction
  • Psychometrics / methods*
  • Quality of Life
  • Surveys and Questionnaires
  • Treatment Outcome


  • Antibodies, Monoclonal
  • Panitumumab